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- The Science of COVID
Spoiler alert: This essay contains an unpopular conclusion, and you may disagree. It’s okay if you do, because you’ll probably be in the company of many of my colleagues who disagree with me too. Today I’m going to talk about when we can trust science. To do that, I’m going to pretend to be a scientist and a philosopher. This is dangerous because, as I have said before, I am neither a scientist nor a philosopher. Instead, I am a practitioner, applying science to the problems of diagnostic medicine. As a practitioner, I must know when science is applicable and when it is not. I know just enough about science and philosophy to be dangerous.
Our experience tells us to trust science, and the explosion of technology during our lifetimes tells us we can. But science is a process, not a product. Not everything labelled as science is science. To understand the difference, let’s consider how science works.
The scientific method begins with a hypothesis. A hypothesis is just an educated guess about some aspect of reality. It is proposed by a scientist as a fact of the world, something that can be relied on to be always true within certain conditions. If the conditions are true, the hypothesis can be used to predict the future and tell us about the past.
Once formed, the hypothesis is communicated to other scientists, who test the hypothesis by experiment. The objective of an experiment is not to prove the hypothesis true; rather, the objective of an experiment is to prove the hypothesis false. If successfully proven false, the hypothesis is rejected. This is the fate of most hypotheses. The path of science is littered by the half-truths of discarded hypotheses. On the other hand, if the hypothesis survives the challenges of repeated experimentation, it becomes elevated by the community of scientists to the status of theory, and its predictions become part of scientific knowledge. This is a relatively rare phenomenon.
The falsification objective of the scientific method is a commonly misunderstood aspect of the process, but it is fundamentally important. It gives science its power over other means of understanding reality, but it also gives science its pace. It takes time to test hypotheses. The proof of a hypothesis can be shortened by increasing the number of simultaneous experiments, but only to a point. Science, like fine wine, requires adequate aging.
For all its power, the elevation of hypothesis to theory illustrates another weakness of the method: theories are created by scientists. Scientists are people, and people make mistakes. Scientists have made many. We can review examples of the most spectacular blunders of scientists later. The point is that the mistakes of science are the mistakes of people, not fallacies in the method.
So why do we trust science? Because, despite its flaws and weaknesses, science has increased our understanding of the world exponentially. But can we be misled by science? Of course we can, and we are most vulnerable when products labeled as science are not developed with strict adherence to the scientific method.
This brings us to the controversial part. Most of everything we have learned and developed in the war against COVID-19, including the tests, the treatments, and the vaccines, should not be trusted as science. In the middle of this emergency, there has not been enough time to fully study the virus and the disease by the scientific method. Rather, what we have so far are merely hypotheses: the best guesses of the smartest and brightest people in the land. To be sure, these hypotheses are our best hope in this fight against pandemic, but they should not be labeled science. There has not been strict adherence to the scientific method. So, what should we trust, what should we view skeptically, and how can we tell the difference? We will address these questions next time.
- The FDA and Its EUAs
We have learned that science is a method, not a product. Science begins with an educated guess which is proven true by a series of experiments designed to show that the guess is false. If the hypothesis cannot be proven false, it is accepted as true by the community of scientists. Now that we’ve waded up to our armpits in philosophy of science, let’s move back into shallow waters and consider the process by which our FDA approves new drugs, medical devices, and laboratory tests in the United States.
First, I am going to reveal a personal bias. I believe that the United States has the safest healthcare system in the world for individual patients. Notice I did not say most efficient, cost effective, or optimized for populations. But if I am sick or injured, I want my healthcare delivered by U.S. trained doctors in U.S. hospitals using drugs, devices and tests approved by the U.S. FDA.
The FDA has been disparaged for being too slow to approve new therapies and methods. True enough, the FDA’s priority is not speed. Instead, the FDA’s mandate is safety. The FDA conducts a thorough, time-consuming review of all details of science supporting an application for approval, granting approval only after all questions have been answered satisfactorily. The FDA conducts post-market surveillance of approved drugs, devices and tests, mandating reporting of adverse outcomes. The FDA’s slow, methodical pace keeps Americans safe.
The FDA does not conduct science. Rather, the FDA performs quality control for science, validating the logic, analytics and data supporting the claims of products submitted for approval. Therefore, FDA approval implies a level of trustworthiness akin to science. But like science, FDA approval takes time. Time is something we do not have in a pandemic.
Enter the Emergency Use Authorization, known as EUA. When time is short, the FDA may allow unapproved medical products to be used to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. All SARS-CoV-2 tests have been made available by EUA. Convalescent plasma is transfused under EUA. Antibody treatments for COVID-19 are prescribed under EUA. Remdesivir, Baricitinib and the their combination are first line treatments for severe COVID-19, available for use by EUA. And COVID-19 vaccines released by Pfizer and Moderna have been made available by EUA. None have been approved by the FDA. The trust conferred by FDA approval should not be transferred to the tests, treatments, or vaccines we are using in the fight against COVID-19.
Are there reasons to believe that the vaccines are safe and effective? Yes, and good ones too. But as with any experimental treatment or product, risks of adverse outcomes are elevated. Individuals must evaluate whether the risks–both known and unknown–are outweighed by the potential benefits of the vaccine. In a recent article published in the New England Journal of Medicine, Dr. Mariana Castells and Dr. Elizabeth Phillips articulately summarize the outstanding questions about the vaccines currently available:
“In the world of Covid-19 and vaccines, many questions remain. What are the correlates of protective immunity after natural infection or vaccination? How long will immunity last? Will widespread immunity limit the spread of the virus in the population? Which component of the vaccine is responsible for allergic reactions? Are some vaccines less likely than others to cause IgE- and non-IgE–mediated reactions? Careful vaccine-safety surveillance over time, paired with elucidation of mechanisms of adverse events across different SARS-CoV-2 vaccine platforms, will be needed to inform a strategic and systematic approach to vaccine safety.”
Some may criticize me for suggesting that the vaccine is not risk-free and that it may be better for some to wait before receiving their shot. However, honesty is one of the foundational characteristics of science. We must be willing to follow the data where it leads, even if it leads to a place we do not want to go. It is dishonest to say that any COVID-19 vaccine has FDA approval; to say that possible adverse effects—short term and long term–have been fully evaluated by the scientific method; to say that the protective immunity imparted by vaccine has been fully studied scientifically; to say that vaccine will alter the course of the pandemic or any infected person’s disease. I am not saying the vaccines will cause harm, but likewise we cannot say the vaccines will not cause harm.
The vaccines available now are associated with the risks of the unknown. For some that risk is worth taking; for others it is not. Whether you decide to take the vaccine or to wait, keep doing what we know slows the spread of disease: mask up, keep apart, and isolate when exposed.
- New Information about Variants and Tests
On January 8, the FDA released a warning that certain PCR tests for SARS-CoV-2 available by EUA may have seriously reduced sensitivity for the SARS-CoV-2 Variant of Concern (VOC, also known as 20I/501Y.V1, VOC 202012/01, or B.1.1.7), resulting in false negative test results. The tests mentioned in this advisory are the Accula SARS-Cov-2 Test by Mesa Biotech, the TaqPath COVID-19 Combo Kit by Thermo Fisher Scientific, and the Linea COVID-19 Assay Kit by Applied DNA Sciences. How will this development impact testing?
The SARS-CoV-2 virus mutates regularly with new strains emerging once every two weeks. Mutations occur in the genetic material of the virus, the very material that molecular test methods like PCR use to detect the virus. Until recently, none of these mutations has been associated with different clinical characteristics, such as more severe disease or increased rate of transmission. However, a variant of concern (VOC) recently emerged in the UK. As far as we know, this is still the one and only VOC. Since this VOC has a much higher rate of infectivity than standard SARS-CoV-2 virus, we can expect it to spread quickly. It will probably soon become the predominant form of the virus in the United States.
PCR tests look for a match in a region of viral RNA. The target sequence is like a computer password: any mistake causes the password to fail, even if the entry is off by only one letter. Therefore, when a mutation occurs in the target region of a PCR test, the test will be unable to detect the virus. This is why the tests mentioned in the FDA warning may not detect all forms of the virus.
Most PCR tests look for a match in more than one target sequence of RNA. Generally, the more targets in a particular test system, the less likely a mutation will impact test results. But beware: negative results should be evaluated in combination with history and symptoms. If COVID-19 is still suspected after a negative test, consider repeat testing with a different test—one with different targets.
How do you know which test you received? Look closely in the fine print of the results—the test used is probably referenced there. If not, ask.
Although most commercially available tests will continue to detect the VOC, these tests do not identify whether the virus is the variant or standard form. They will only identify that a SARS-CoV-2 virus is present. Furthermore, there is no assurance that a variant will not emerge that evades detection.
Obviously, this is a situation we will continue to follow closely.
- Where’s the Flu?
Since October, all rapid SARS-CoV-2 PCR tests performed at the hospital laboratories where I work have included a PCR test for flu. But of the thousands of tests performed, not one positive flu has been detected. Has COVID cured flu?
No, I don’t believe that COVID has cured the flu, but I believe that masks have dramatically reduced the prevalence of flu in the community. Flu is a respiratory infection, passed from person to person by the same transmission mode as COVID, mainly inhaled droplets from an infected person. Standard face coverings reduce flu transmission in two ways. First, droplets from an infected person are less likely to be spread into the surrounding air; instead, they hit the mask and fall. Second, the mask helps filter the air of droplets that may contain viral particles. The result is a reduction, but not an elimination, of respiratory viral transmission.
So why haven’t masks cured COVID? SARS-CoV-2 is more infectious than flu, meaning that compared to flu, far fewer SARS-CoV-2 viral particles are needed to cause infection. Masks reduce the number of viral particles in the air, but they don’t eliminate them. Some virus leaks out from the masks of infected persons, and some virus can be inhaled by masked individuals nearby. It’s a matter of how much virus gets inhaled. It takes much more flu to cause infection than SARS-CoV-2. Masks slow the spread of COVID-19, but do not eliminate disease the way masks have flu.
We may use this COVID/Flu comparison to make some predictions about the B.1.1.7 variant, the “variant of concern” now reported in at least 70 countries. This variant is reported to be much more infectious than the standard SARS-CoV-2 virus, about fifty percent more, with the consequence that masks may not be enough to slow its spread through the community. Tighter, less permeable, and more uncomfortable masks may be necessary to protect against this variant as it spreads across our nation. The higher transmission rate also predicts that this variant will soon be the dominant form of the SARS-CoV-2 virus in the U.S.
If standard face coverings may soon become less effective protection against COVID-19, maybe now is the time to learn about different types of masks. We will do that next time.
- The Mask Clinic
Face coverings, N95 masks, respirators, and P99 masks—how do we make sense of this confusing alphabet soup?
Standard face coverings do not have a rating. They made from cloth or paper, and they usually resist fluids. But they leak. Air comes in around the sides–anyone who has worn a mask (and who hasn’t?) knows this. Nevertheless, mask usage is key to protecting you from exposure to SARS-CoV-2, the virus that causes COVID-19. However, there are more infectious organisms that require a rated mask for protection. One such organism is Mycobacterium tuberculosis, the organism that causes tuberculosis. Another such organisms may be the B.1.1.7 variant of SARS-CoV-2, the variant of concern, which has a transmission rate fifty percent greater than standard SARS-CoV-2.
Rated masks have a letter prefix, either N, R, or P, followed by a number, usually 95, 99 or 100. The letter refers to how resistant the mask is to oil, and the number refers to the percentage of airborne particles filtered by the mask.
Mask Type Airborne Particles Filtered Resistance to Oil N95 At least 95% No N99 At least 99% No N100 At least 99.97% No R95 At least 95% Somewhat P95 At least 95% Strong P99 At least 99% Strong P100 At least 99.97% Strong These masks are held snuggly around the face by elastic bands or straps around the head that eliminate the gaps between the skin and the mask. Note that “KN95” masks do not meet U.S. standards, and often have bands that loop over the ears and not over the head. Don’t let the word “respirator” confuse you: respirator is just another name for a rated mask. All the masks in the table above are also known as respirators. For protection against most respiratory organisms, an “N” mask is adequate since resistance to oil is not necessary.
So what level of protection is needed? Standard face coverings are adequate protection against SARS-CoV-2 exposure if worn properly by all individuals interacting at distances less than six feet, but an N95 mask is needed to provide adequate respiratory protection against tuberculosis. At 2 microns long, tuberculosis organisms are much larger than SARS-CoV-2 particles which measure 0.1 microns or less. Still, I believe that N95 masks also provide adequate protection against COVID, even when unmasked, infected individuals are nearby because of the experience of collectors at the test collection centers run by the laboratories where I work. These collectors use an N95 mask and a face shield for respiratory protection, and none has become infected at work despite collecting thousands of positive swabs.
How does an N95 mask work? In addition to forming a tight seal on the face around mouth and nose, N95 masks are made from material with pore sizes between 0.1 and 0.3 microns in diameter.
“But wait!” you might say, “You said that a SARS-CoV-2 virus particle is 0.1 microns or less. What keeps the virus from slipping through?” The spread of SARS-CoV-2 virus is on respiratory droplets. These droplets are 5-10 microns in diameter, much larger than the pore size of the masks, keeping most viral particles out of the nose of the mask wearer.
What about the coming B.1.1.7 variant of SARS-CoV-2? I want to be very clear: the FDA does not recommend the general use of an N95 or higher rated mask for COVID-19 prevention. Although N95 masks protect against SARS-CoV-2, there continues to be supply shortages of these masks. Therefore, the FDA recommends that their use be reserved for health care providers. However, as we discussed last time, there may soon be a time that this recommendation changes. It is possible that an N95 mask will be required to protect against the B.1.1.7 variant because of its higher transmission rate.
So what other new information is there about the SARS-CoV-2 variants? We will discuss the latest information about variants next time.
- The Latest about Variants
The CDC recently released new information about the variants of SARS-CoV-2, updating information previously released.
Although SARS-CoV-2 mutates frequently, about once every two weeks, most mutations do not result in a clinically different virus. However, three variants have emerged which are being watched closely.
B.1.1.7 is the first variant of concern which emerged in the UK last December and is now present in at least 70 countries, including the United States. This variant is associated with a fifty percent higher transmission rate, which means it may soon be the dominant form of the virus. There is emerging data that suggests this form of the virus is also associated with a higher death rate.
B.1.351 emerged in South Africa and has spread to other countries, including the United States. There is data that suggests that the Moderna mRNA-1273 vaccine currently used in the US may be less effective against this variant.
P.1 has been found in Japan and Brazil. As of late January, this variant is known to exist in the United States. There is data suggesting this variant may be less susceptible to immunity acquired either by previous infection or by vaccination.
All three variants are concerning because of mutations in the spike proteins in the virus. These proteins are significant because they are responsible for the binding of virus to cells in the back of the nose, the first step in infection. They are also significant because antibodies in the human immune system work by recognizing these spike proteins. Whether these antibodies come from natural immunity (i.e., previous infection), induced immunity (i.e., vaccination) or convalescent plasma, altered spike proteins may allow viral particles to slip past this line of protection.
Since we’ve talked a lot about vaccination recently, now may be the time to discuss how COVID vaccines work. We will pick up there next time.
- mRNA Vaccines
To understand how mRNA vaccines work, we must first have a basic understanding of cells and genetics. Zzzzzzz. Wait! Before you go to sleep, we’re going to make this really short and really simple. Cells are bags of jelly—jellybeans, so to speak—and in those jellybeans is a kernel called a nucleus. DNA lives in the nucleus, and like the cell’s hard drive, DNA stores and preserves the cell’s genetic code. Genetic code is a series of nitrogen bases strung together to form nucleic acid. There are only four possible bases, so just like computer code is a series of 1’s and 0’s, genetic code is a series of A’s, T’s, G’s, and C’s, each letter standing for a different nitrogen base. DNA is arranged in two complimentary stands—the famous double helix of Watson and Crick—to create code redundancy like mirrored hard drives that protect your data in case of a crash.
When the genetic code needs to be accessed, a specific portion of the DNA untwists, exposing a segment of code which is copied onto a new strand of messenger RNA (mRNA). Unlike DNA, RNA is only a single strand of nucleic acid and much less stable. The mRNA floats into the cell jelly, the cytoplasm, where ribosomes attach and move along the strand, coupling together amino acids as they go. Every sequence of three bases on the mRNA, known as a codon, codes for a specific amino acid. For example, GCA codes for alanine, CAA codes for glutamine, and so on. There are 20 different amino acids, each with its own codon or codons (some have more than one). Put together according to the sequence of bases on the mRNA, the amino acid chains become a protein. Out of the trillions of possible amino acid combinations, the proteins formed by your genetic code define the shape of your nose, the length of your bones, the complexion of your skin and everything else that makes you you. Once the right number of proteins have been made, the mRNA disintegrates into the cytoplasm of the cell. The process starts again in the nucleus, and a new protein is created as called for by the cell.
What if mRNA could be injected directly into cytoplasm without first being created in the nucleus? Then the cell’s machinery could create a protein that wasn’t part of the cell’s genetic code. That’s exactly the hypothesis behind mRNA vaccines. After the vaccine delivers mRNA into the cytoplasm of muscle cells in the arm, those cells begin forming the protein coded by the mRNA in the vaccine—in the case of COVID vaccines, one of the spike proteins known to exist on the SARS-CoV-2 viral capsule—and those proteins make their way to the surface of the cell where the immune system forms antibodies which are memorized by the body for future use. How cool is that!
Various companies have been working on mRNA vaccines for over a decade, but none made it to production until the pandemic demanded rapid vaccine development. Although never been used on a large scale before, mRNA vaccine technology is appealing for several reasons:
- Molecular sequencing systems makes creation of mRNA almost as easy as writing a computer script.
- Once sequenced, mRNA can be mass produced easily and cheaply.
- There is no danger from viable pathogens in the vaccine production.
- There are no infectious agents or toxins injected into the vaccine recipient.
- Once the delivery system is perfected, vaccinations for many different pathogens can be created by simply altering the mRNA sequence, making it possible for vaccines to respond quickly to emerging viral variants.
Before we anoint mRNA vaccines as our pandemic savior, we should first listen to voices urging caution about this new technology. For example, in a recent New England Journal of Medicine publication, Dr. Mariana Castells and Dr. Elizabeth Phillips note that the incidence of anaphylaxis, a serious, sometimes fatal allergic reaction, associated with the Pfizer SARS-CoV-2 mRNA vaccine is “10 times as high as the incidence reported with all previous vaccines, at approximately 1 in 100,000, as compared 1 in 1,000,000.” Why? And moreover, what are our expectations of vaccination? Do vaccines prevent COVID or simply reduce COVID complications? How long will immunity last? Who should NOT get the vaccine? Answers to these and other questions are not readily apparent, not because of a failure of diligence, but because there has simply not been enough time to collect, compile and analyze the data that will eventually yield answers.
The Center for Evidence Based Practice at the University of Pennsylvania recently published a review of the adverse effects of mRNA vaccines. Among their findings are the following:
- There are no specific guidelines for use of messenger RNA (mRNA) vaccines or contraindications to mRNA vaccines.
- No large trials of any mRNA vaccine have been completed yet.
- The only evidence on safety of mRNA vaccines comes from small phase I and phase II trials of SARS-CoV-2 vaccines, with follow-up typically less than two months.
- Systemic adverse events such as fatigue, muscle aches, headache, and chills are common
- The rate and severity of adverse events appears to be higher for the second dose of vaccine than for the first.
- Higher vaccine doses appear to increase the rate and severity of adverse events.
- Larger trials of SARS-CoV-2 vaccines are in progress, with results expected in mid-2021.
- There is not sufficient evidence to support any conclusions on the comparative safety of different mRNA vaccines.
- Direct evidence on the comparative safety of mRNA vaccines and other vaccines is lacking.
Clearly, mRNA vaccines offer an attractive, promising alternative to other vaccine technology, especially when a new vaccine is needed quickly. However, it is a new technology associated with risks of the unknown. Many unanswered questions remain, demanding a sober examination of the evidence for and against vaccine safety. Since the risk-to-benefit ratio from taking a COVID vaccine varies individually, I urge individual decisions, not collective ones. The Infectious Diseases Society of America recently published a comprehensive FAQ on vaccine safety which you may find to be a valuable great resource for making an individual decision.
Although paved with good intentions, the early path of new technologies is frequently littered with unintended consequences. Next time, I will tell a story of good intentions that ended tragically for many.
- We Have No Bananas
When Texas freezes over, most everything closes. That includes blood collection centers, which were closed for 5 days this week. I’m writing to encourage you to donate blood. If you’re a bottom-line person, you can skip this blog, find a donation site, and sign-up to give blood by clicking here.
For those of you still with me, this is what I saw at the grocery store last night:
There were no bananas. What does that have to do with blood donation? Read on; I’ll tell you.
Blood has four parts. First, there are the red cells which carry oxygen to the tissues in your body. Oxygen is the fuel that makes cells go. Without oxygen, cells get cold and die. When people bleed, they lose these fuel-carriers, and their body goes on the biologic version of rolling blackouts, shunting blood towards essential internal organs at the expense of less vital parts like fingers and toes. The second part of blood are white cells. These are the infection fighting cells of your immune system. Like first responders, white cells are carried by blood to the front lines of battle, where they protect you from invasion. Third, blood contains platelets which are little bits of larger cells that act like the Fix-A-Flat you put in bicycle tires. Platelets circulate in the blood looking for holes to plug, helping slow down or stop bleeding. The fourth part of blood is plasma, the liquid part. Plasma contains proteins, hormones, antibodies, clotting factors, and all the other stuff that needs to be carried from one part of your body to another.
Most people have all four parts of blood in excess, but the blood center will test before collection to make sure you will not miss the unit you donate. The unit you give is divided into three parts, so every donation helps three different people. The collected red cells are separated into one bag, the platelets into another bag, and the plasma into a third bag. The white cells collected are not used.
Red cells are like milk. They must be refrigerated, and they expire after about a month (up to 42 days). Plasma is like frozen vegetables. Once frozen, plasma can be stored for a year. But platelets are like bananas. They are stored at room temperature, and they are only good for five days. So when Texas freezes over, we run out of bananas, and we run out of platelets.
Blood bank inventories are slim during the first part of the year. After the holidays, people don’t feel like donating blood. That’s understandable, but our hospital blood banks suffer critical shortages as a result. This year is no exception; blood banks were dealing with critical shortages before the freezing weather. But two massive winter storms this week have reduced blood inventories to nearly nothing. That’s why your urgent action is needed.
There is no substitute for donated blood. There are no synthetic red cells or platelets, and there is no substitute for human plasma when it is needed. To have blood products available when you or your family need it, you must make blood available to your neighbors today. Please, your community needs your blood. Find a donation site, and sign-up to give blood by clicking here.
- Shouldna Taken That Shot
It was a heady time to be a scientist. Albert Einstein was still alive, and his special and general theories of relativity changed our understanding of the universe. Quantum physics predicted space travel and limitless energy. We had a brand-new theory of gravity, of space-time, of waves and particles, and of the atom. Vaccines had nearly wiped smallpox off the earth. We had penicillin, saving many lives and limbs. Science, it seemed, could conquer all. So, when your doctor said you needed a shot to prevent a miscarriage, you took an injection without question.
DES (diethylstilbestrol) is a synthetic estrogen created by Sir Charles Dodd in 1938. Cheap and easy to produce, pharmaceutical companies marketed DES for prevention of menopause symptoms in women. In 1947, the FDA approved DES for use to prevent miscarriages, and such use was advocated by an article published in the American Journal of Obstetrics and Gynecology. American obstetricians enthusiastically embraced the new drug as a cure for one of the most unhappy outcomes in their profession. Although some physicians questioned its effectiveness, DES continued to be commonly prescribed in the United States to women with threatened miscarriages until 1971.
That’s when a bombshell was published in the New England Journal of Medicine. The daughters of women who received DES during pregnancy had an unignorably high rate of clear cell adenocarcinoma of the vagina, an extremely rare tumor in women whose mothers had not received DES. That’s right—a drug manufactured and sold in the United States, approved by the FDA, prescribed as intended by licensed physicians—caused a rare cancer in young women. And not just clear cell adenocarcinoma. The daughters of women who received DES during pregnancy have higher rates of breast cancer, abnormal cells on their pap smears, anatomic defects in their reproductive organs, trouble getting pregnant, and problems during pregnancy. And not just the daughters—the sons too have increased rates of benign tumors and structural defects in their reproductive organs. Even the mothers are affected. Women who received DES during pregnancy have an increased risk of breast cancer. Does it stop there? Research is currently ongoing on the third generation, the grandchildren of women who received DES during pregnancy.
Clear cell adenocarcinoma of the vagina. Although it’s not a story my profession likes to tell, the lessons of the DES tragedy must never be lost. Before we accept the opinions of experts, we must be mindful of the limitations of science. Before we are swept along with the crowd, we must recognize the possibility of unintended consequences. Before we act on conventional wisdom, we must think; think with our own brains, and make up our own minds. We must ask questions, critically examine data, and make judgements by what we know from experience. We must all be scientists now.
- Vaccine and Quarantine
On February 10, the CDC updated quarantine guidance for vaccinated individuals exposed to COVID-19, giving some people a get out of jail free card.
According to the new guidance, individuals who received their second FDA authorized mRNA vaccine injection between 14 and 90 days ago need not quarantine after exposure to COVID-19 provided they are symptom free.
An exposure is still defined as an encounter of more than 15 minutes and less than 6 feet with someone infected by SARS-CoV-2 when one or both individuals are not wearing a mask. Provided that there is no fever or other indications of upper respiratory infection in the exposed individual, quarantine is not necessary for those who received both doses of either the Pfizer or Moderna vaccine more than two weeks before the exposure. However, vaccinated individuals should monitor for symptoms (i.e., take daily temperatures) for 14 days after exposure, and should quarantine immediately if symptoms (i.e., fever) develop. This reduced quarantine requirement does not apply to individuals who complete a vaccination series which has not receive an EUA from the FDA, such as vaccines approved in countries outside the United States.
If it has been more than two weeks since you completed a vaccine series, then you benefit from reduced quarantine requirements after exposure. But you don’t get to party like it’s 2019! You may still be able to spread the virus to others, so you must still mask and social distance in public. Furthermore, no one knows how long vaccine-induced immunity will last.
The CDC maintains that natural immunity—immunity from infection—lasts for at least 90 days. It may last longer, but the CDC is still unwilling to say so. Since the CDC’s new quarantine exemption also expires after 90 days, it seems reasonable to infer that 90 days may be the outer limits of immunity, whether from previous infection or vaccination. We may hope that it’s longer, but so far, the CDC has not said so.
So what does all this mean? If it has been more than two weeks since you completed Pfizer or Moderna vaccination series, you have a get out of quarantine jail free card—you don’t have to quarantine after a potential exposure if you are symptom free. However, a vaccination does not make you special in any other way. You must monitor for symptoms for 14 days after exposure. You must quarantine immediately if you have symptoms. You must continue to mask and keep apart in public. In other words, even if you have completed a vaccination series, you don’t have this card:
At least not yet.
- New Vaccine
There were a couple of big changes in the COVID vaccine landscape last week. On Thursday, February 25, the FDA reissued its EUAs for the Pfizer and Moderna COVID-19 vaccines, revising portions of their original EUAs. On Saturday, February 27, the FDA issued a new EUA for the Janssen COVID-19 vaccine, commonly known as the Johnson and Johnson vaccine. Lots of news, too much for one blog. Let’s address the important information one bite at a time, starting with the Janssen vaccine.
Like all other COVID-19 vaccines, the Janssen vaccine has not been approved for use by the FDA. Instead, these vaccines are authorized for use in the U.S. This authorization is based on the FDA’s authority to make unapproved products available during an emergency when “there are no adequate, approved, and available alternatives.” As stated in the EUA letter issued February 27, 2021, “It is an investigational vaccine not licensed for any indication.” This means that clinical trails on vaccine safety and effectiveness have not been completed. Expect comprehensive analysis of clinical trials this summer at the earliest.
However, the Janssen vaccine differs from the other two vaccines in important ways. First, it is not an mRNA vaccine. Rather, it is a recombinant vector vaccine. This vaccine is made by inserting genetic code for a protein of the target into a harmless virus (the “vector”). When injected, this harmless virus presents the target proteins to the immune system, causing formation of antibodies, in this case antibodies to the spike proteins on the SARS-CoV-2 capsule. This technology is not entirely new. Manufactured (or “recombinant”) genetic code has been used to synthesize proteins for vaccines for nearly a decade. Recombinant flu vaccines received FDA approval in 2013. You may have received a recombinant flu vaccine in recent years. The difference between recombinant protein vaccine and viral vector vaccines has to do with where the antigenic proteins are made–either in your body (viral vector) or outside your body (recombinant protein). The harmless virus (the “viral vector”) cannot replicate within your body, so the effect is the same.
There are more differences. According to data submitted to the FDA, the Janssen vaccine is less effective preventing moderate to severe COVID-19 than the Moderna and Pfizer vaccines. The Janssen vaccine requires only one doses compared to the two doses required by Moderna and Pfizer. Storage of the Janssen vaccine is easier to accomplish than the other two. Vaccines features are compared as follows:
Pfizer Moderna Janssen Vaccine Technology mRNA mRNA Recombinant Vector FDA Approval No No No Effective rate 95% 95% 66% Minimum Age 16 years 18 years 18 years Doses 2 2 1 Storage -70°C -70°C Refrigerated Time between doses 3 weeks 1 month Not applicable Current comparison among authorized COVID-19 vaccines. There is another difference. In its reissued EUA, the FDA has required Pfizer to disclose post-authorization adverse events in its fact sheet to health care providers. We will discuss that next time.
- New Guidance for the Fully Vaccinated
Yesterday, the CDC published new guidance for fully vaccinated individuals. In this article, we will summarize the key points of this new guidance.
First, we must understand what it means to be fully vaccinated. The full effect of vaccine-induced immunity takes about 2 weeks, so an individual is considered fully vaccinated 14 days after the final vaccine injection. The final vaccine injection is the second dose of the Pfizer or Moderna vaccine, or the single dose of the Janssen vaccine.
Last month, the CDC issued guidance lifting the quarantine requirements for fully vaccinated individuals following a COVID exposure, provided they remain asymptomatic. Previously, this permission expired after 90 days. Yesterday, the CDC affirmed its previous guidance, but lifted the 90-day expiration. According to current CDC guidance, there is no longer an outer time-limit for the benefit of vaccine-induced immunity. This is bound to change; we will follow closely.
To the removal of quarantine requirement, the CDC also added two additional liberties yesterday: (1) fully vaccinated individuals may visit indoors with other fully vaccinated individuals without wearing masks or social distancing, and (2) fully vaccinated individuals may visit with unvaccinated people from a single household who are at low risk for COVID-19 without wearing masks or social distancing.
Other COVID precautions remain in force for fully vaccinated individuals, including masking and social distancing in public except in the specific situations mentioned above. If symptoms develop, fully vaccinated individuals should follow the same quarantine and testing recommendations of unvaccinated individuals.
- New Variant Classification
Last week the CDC revised its classifying terminology for SARS-CoV-2 variants. To have clarity in our thoughts and debates, we must be precise in our language. Poor decisions often descend from muddled and incomplete understandings. I know that readers of these posts strive to be current in models of understanding and language, so they will not be caught flatfooted in conversation and reasoning. That’s why I summarize the essential points here.
There are now three types of SARS-CoV-2 variants: Variants of Interest, Variants of Concern and Variants of High Concern. I will discuss the definitions, lists of variants and their characteristics in reverse order.
Variants of High Concern. Variants of high concern are those SARS-CoV-2 variants that cannot be detected by tests, are not treatable by current therapies or for which natural or vaccine induced immunity offers no protection. Any one of those three criteria is enough to place the variant on the High Concern list. Scary stuff. The good news is that there are no variants on this list. At least not yet.
Variants of Concern. Variants of Concern have reduced detection by tests, reduced response to therapy, reduced immune protection, greater transmissibility, or more severe disease. Again, any one of these criteria is enough to land a variant on this list. The bad news is that the number of variants on this list has exploded since the last time I wrote about it. In addition to the B.1.1.7 variant first detected in the UK last fall, four other variants have been added to the list:
These Variants of Concern have all been identified in the United States. The B.1.427/429 Variants of Concern are most prevalent in the western United States, now responsible for more than half of infections in California. The B.1.1.7 Variant of Concern is most prevalent in New Jersey and Florida, approaching 10% of the new viral infections there. Click here to view the current numbers and distribution in the United States. To see worldwide cases of COVID-19 caused by variants, click here. These maps are updated at least weekly.
Variants of Interest. Variants of Interest are being watched closely because they have the potential to become Variants of Concern based in the mutations within the variant, even though they don’t fulfill criteria to be a Variant of Concern based on observation. This may be because the variant is too new or because too few of the instances of the variant exists to make meaningful observations. The current Variants of Interest and their potential, but not observed, effects are listed below:
Like the Variants of Concern, all the Variants of Interest are currently present in the United States.
There are a number of other variants which have been identified and named, but which have not yet been classified as a Variant of Interest, Variant of Concern, or Variant of High Concern. Expect the members of these variant classification lists to change and shift as more becomes known about variants.
- Breakthrough
As more Americans are receiving COVID vaccinations, there are reports of COVID occurring in individuals who have been fully vaccinated. Can this really happen?
Yes, you may still become sick from a SARS-CoV-2 infection even if more than two weeks have passed since your final vaccine injection. “Breakthrough” is the term for this type of infection, and many state health departments have reported breakthrough infections. According to current CDC reports, over 50 million Americans have been fully vaccinated, accounting for 15.1% of the total U.S. population, yet 7-day rolling averages for new COVID-19 cases and hospital admissions for COVID are up 6.7% and 2.6% respectively.
We know that breakthrough infections occur with other vaccines. In years past, many patients were admitted to the hospital for flu even though they received a flu vaccine earlier in the season. We may be seeing a similar phenomenon with the COVID vaccine. Furthermore, we still do not know whether most breakthrough infections are caused by the original SARS-CoV-2 virus, or one of the emerging variants. It is possible that vaccine is less effective against one or more variants.
We have a lot to learn about breakthrough infections, but this much is clear: the pandemic is not over, and the vaccine is not a panacea. While vaccine may provide an added layer of protection against dying from COVID, it does not prevent contraction of disease. For now we must continue to do what we know keeps us safe: mask in public and keep apart, even if you have received a vaccine.
- Anaphylaxis
In the revised EUA issued for its COVID vaccine on February 25, 2021, the FDA required Pfizer to updated its “Fact Sheet for Healthcare Providers” to include post-authorization adverse effects. As a result, Pfizer’s fact sheet now states, “Severe allergic reactions, including anaphylaxis [emphasis added], and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.” Moderna did not receive the same mandate to revise its fact sheet, which still does not include a similar warning about anaphylaxis. What is anaphylaxis and what are the facts about this life-threatening vaccination complication?
Anaphylaxis is a severe allergic reaction in which your body releases a flood of chemicals designed to modulate the immune response all at once. The result is a sudden drop in blood pressure and narrowing of airways which can lead to fainting and death. Some people are more prone to anaphylaxis than others, and some stimuli are more common causes of anaphylaxis than others. Peanuts and bee stings are common examples. The allergic response can be effectively reversed by an injection of epinephrine. Susceptible individuals (and you know who you are) often carry EpiPens to self-administer a dose of epinephrine in case of a reaction.
Anaphylaxis can occur anytime something is injected in the body, although the risk is exceedingly low. However, the rate of anaphylaxis after the mRNA vaccines is about ten times higher than the rate of pre-COVID vaccines. If this is the case, then why did Pfizer’s new EUA highlight this potential complication and Moderna’s did not? The answer may be related to initial experience with the two vaccines. Since Pfizer received authorization for its vaccine first, increased anaphylaxishad already been observed in association with the Pfizer vaccine before Moderna even received its EUA. The reputation stuck. Although initial reports suggested that Pfizer caused more than twice as many anaphylaxis reactions as Moderna, subsequent experience has shown that both mRNA vaccines have about the same rate of anaphylaxis. According to a March 16 CDC report 1,913 deaths have been reported associated with vaccine administration after more than 109 million doses. Reports of recent VAERS data searches, the FDA database collecting vaccine adverse events, suggest that the rate of anaphylaxis deaths are similar for the two vaccine manufacturers. The Janssen recombinant vector vaccine appears to be associated with fewer cases of anaphylaxis than the mRNA vaccines; time will tell whether this observation sticks or is skewed by the fewer number of vaccines administered so far. The CDC recommends that all vaccination administration sites be prepared for potential anaphylaxis reactions, including educating staff on the signs and symptoms of anaphylaxis and having at least three epinephrine doses on hand at all times.
A few sensible conclusions may be drawn from this information.
- Ask the person administering your vaccine what would happen if you had an anaphylaxis response.
- If you have an EpiPen, bring it with you when you get your vaccine.
- If you have had a severe allergic reaction in the past, consider deferring vaccination or taking the Janssen (Johnson and Johnson) vaccine instead of an mRNA vaccine.
- Antibody Tests after Vaccination
The CDC recently updated guidelines for interpretation of SARS-CoV-2 antibody tests after infection and vaccination. There is currently no recommendation to measure antibodies after vaccination to determine vaccine effectiveness. Despite this, I know vaccinated individuals who measure antibodies anyway, and they are surprised when antibody tests come back negative.
Okay, full disclosure. It was me. And my wife. We took the Janssen vaccine in mid-March, and I checked our SARS CoV-2 IgG antibodies last week. They’re negative. For both of us. What’s going on here? Isn’t the point of vaccination to stimulate the production of antibodies?
The answer is a qualified yes. The qualification comes in two parts: the “scientific explanation” and my opinion.
First the “scientific explanation”, simplified. An individual may produce three types of antibodies against SARS-CoV-2: N, S or RBD. Infection stimulates the production of all three types of antibodies, but vaccine stimulates the production of S antibodies only. Therefore, vaccinated individuals who have never been infected will be S-antibody positive, but N and RBD antibody negative. If the antibody test is designed to detect N or RBD antibodies, but not S antibodies, then the result will be negative in those individuals. On the other hand, detection of N or RBD antibodies in a vaccinated individual means that the individual has been exposed to the virus, either before or after vaccination. The trouble is that the antibody tests available today by emergency authorizations do not specify which type of antibody is measured. We do not know which antibody we are measuring unless we know details about the test, details that are usually not listed on the report from the lab.
This explanation has precedent. We know, for example, that Hepatitis B infection stimulates the production of two different types of antibodies: core antibody and surface antibody. Hepatitis B vaccine only stimulates production of surface antibody; it does not stimulate production of core antibody. Therefore, someone who is positive for surface antibody only has been vaccinated but has not been infected. On the other hand, someone who is positive for both surface and core antibodies has been infected by Hepatitis B in the past.
All well and good for hepatitis, but what about SARS-CoV-2? In the case of SARS-CoV-2, the “scientific explanation” is a hypothesis, meaning it is an educated guess. Before we can say that we know something, we must compare our hypothesis to real-world observations. There has not been enough time to observe the response that our bodies really have to vaccine. It doesn’t make the hypothesis wrong, but it doesn’t make it right either.
My opinion? The “scientific explanation” is still an opinion.
- Janssen Pause
These blogs advocate caution and skepticism, specifically in response to the COVID pandemic, but more generally in response to all “scientific” proclamations. Don’t “follow the science” blindly. Instead use your “smell test” before believing anything labelled as science. Remember that science does not prove reality. Instead, science proves what is not real. We know much less than we would like to believe.
The sudden “pause” in vaccine rollout announced last week by Janssen is a case in point. The pause follows reports of six cases of unusual blood clots following administration of the vaccine, tragically including one death.
These unusual blood clots are called cerebral venous sinus thrombosis, or CVST, a condition which blocks the flow of blood out of the brain. As a result, the blood vessels may burst causing a stroke which may permanently damage brain tissue. So far, all patients are women under 50 years old with low platelet counts.
An association between COVID-19 and CVST was noted before the Janssen vaccine was released. In the August 2020 edition of the American Journal of Neuroradiology, Dr. D. D. Cavalcanti and associates reported three COVID-19 patients under 41 years old who developed CVST; all three patients died. Others have reported similar associations between CVST and SARS-CoV-2 infection.
This raises several questions. Can CVST be caused by COVID-19? Can CVST be caused by the Janssen vaccine? What about the mRNA vaccines? And how is it that a vaccine causes a complication of the disease it’s meant to prevent? Furthermore, six instances of CVST out of 6.8 million doses of the Janssen vaccine administered is a complication rate of less than 1 in 1,000,000. The rate of anaphylaxis associated with the mRNA vaccines is 10 times as high. Why so much concern for such a rare complication?
Something doesn’t smell right to me.
- More Variants Emerge
As new variants emerge, it’s time to update our charts so you will know what’s coming and what to watch for. In its summary released last week, the CDC made minor terminology revisions and made some roster changes on the line-up cards. In this edition, we will highlight the changes and update our charts with the latest information.
Variants of High Consequence. Now called Variants of High Consequence instead of Variants of High Concern, these SARS-CoV-2 strains cannot be detected by tests, are not treatable by current therapies, or are not protected by natural or vaccine induced immunity. A strain that fits any of these categories must be reported to the WHO and CDC immediately. Thankfully, this list is still blank.
Variants of Concern. Variants of Concern have reduced detection by tests, reduced response to therapy, reduced immune protection, greater transmissibility, or more severe disease. Although there have been no additions to this list, there have been noteworthy updates to our understanding of these variants. For example, B.1.1.7, the UK Variant, and B.1.351, the South African Variant, remain at the top of the increased transmissibility list at 50%; however, as we predicted in January, B.1.1.7 is also now the most prevalent lineage of the virus in most regions of the U.S. except the west coast. The California Variants B.1.527 and B.1.529 are now considered the most resistant to therapy of all U.S. variants.
Variants of Interest. Variants of Interest are U.S. variants with the potential to become Variants of Concern based in the mutations within the variant, even though they don’t fulfill criteria to be a Variant of Concern based on observation. Two changes have occurred. First, B.1.525 is now believed to have first originated in the U.K. and Nigeria, even it continues to be most prevalent in New York. And second, since last writing, a new variant, B.1.526.1 has spun off the New York Variant B.1.526. This gives us the opportunity to briefly explain the classification system I have been using.
Because SARS-CoV-2 mutates so quickly, new variants emerge rapidly. The PANGO lineage system attempts to apply some order to this chaos. Names begin with a letter designating a unique lineage, followed by a series of numbers separated by dots. For example, the U.K. Variant B.1.1.7 is the seventh named variant of the B.1.1 lineage, and B.1.1 is the first named variant of the B.1 lineage, and so forth. By looking at the name B.1.526.1 we know that this variant evolved from the New York Variant B.1.526, but that it has enough unique characteristics to merit its own name. The variant’s family tree is embedded in the name. For example, B.1.1 and B.1.526 are siblings, B.1.526.1 and B.1.1.7 are cousins, and B.1 and P.1 are from totally different families. It’s a useful although not perfect system, and like everything in the pandemic, it continues to evolve.
Thousands of variants have been described. The ones highlighted in the charts below are currently considered the most important in the U.S:
- Herd Immunity
What is herd immunity and when will we get there?
Imagine a billiard table with balls racked at one end. Smash a cue ball into the neat arrangement and all the balls will move. That’s like the pandemic. The energy spread from ball to ball is like the spread of virus from person to person.
Now imagine the same table, except this time some of the balls are bolted onto the table so they can’t move. Smash a cue ball into the rack and not as many will move. The bolted balls are like people with immunity; they absorb energy and do not allow it to spread. How many balls must be bolted onto the table to prevent spread of motion across the table? That’s herd immunity; the percentage of people with COVID-19 immunity that it takes to stop the uncontrolled spread of virus.
Epidemiologists differ on herd immunity targets for COVID-19, with estimates varying from 60% to 90%. But these estimates are just educated guesses. Herd immunity is something observed, not something predicted. When the rates of disease reach a stable low level, herd immunity has been achieved.
Now some observations from my point of view. Last week, without a decline in the number of tests performed, there were only 6 positive SARS-CoV-2 tests in the laboratory where I work. Until last week, weekly positives have been in the double digits going back to April 2020, with a peak of 475 during the first week of this year. Since the last week in February, the weekly number of positive tests have been below 40. The curve has flattened, despite the lifting of many restrictions designed to prevent spread of the disease in Texas. We can no longer say that there is a COVID-19 epidemic in my community. Instead, the disease appears to have reached endemic levels here.
I need to pause to explain what I mean. Disease prevalence, which we’ve defined before, means the rate of disease in a population. Prevalence can be applied to any disease, not just infectious disease; thus, we can speak of the prevalence of diabetes, of breast cancer, of heart disease, and so on. Epidemic simply means increasing prevalence, just like acceleration means increasing speed. Endemic means that disease prevalence is stable and not changing. Epidemics can be local, meaning confined to a house or a neighborhood or a city or a country, or epidemics can be global, meaning happening all over the world at once. Global epidemics are called pandemics. The term “global pandemic” is as redundant as “unexpected surprise” or “advance warning.”
Herd immunity is achieved once an infectious disease reaches endemic levels, but what is that number? Assuming natural and vaccine-induced immunity are the same thing, then herd immunity is the percentage of folks who have either had the infection or the vaccine when disease becomes endemic. Today, it is estimated that 10% of Texans (2.8 out of 28 million) have had COVID-19, and that 35% of Texans have been fully vaccinated. Therefore, my area seems to have achieved COVID-19 herd immunity at 45%.
This all sounds like great news, so why not throw our masks in the air and celebrate? There are still unanswered questions. Vaccine-induced immunity is not the same as natural immunity, but is it the same enough for calculating herd immunity? How long does immunity last? Can herd immunity be lost once achieved? What will be the impact of emerging variants on immunity of individuals and populations? And, most puzzling to me, why is the virus surging now in India and Brazil despite previous waves of infection?
We still don’t know as much as we would like to believe.
- Why Vaccinate COVID-19 Survivors?
In these posts I use my experience as a practicing pathologist to present clear, simple, and understandable explanations of important issues relating to the pandemic amid the noise and misleading half-truths we encounter daily. When I don’t know, I tell you. Today, I’m asking you to help me understand something that’s been puzzling me for weeks. Why does the CDC adamantly insist that COVID-19 survivors be vaccinated?
The CDC’s statement is simple enough. They say that there is a wide range of outcomes to SARS-CoV-2 infection, from no effect to death, and that there is a corresponding range of immune responses to infection. Those who had mild disease, the argument goes, may not have built up the immunity necessary to fight future infections. The vaccine, on the other hand, is a measured dose designed to stimulate an adequate immune response. Furthermore, they assert that there is no data on how long natural immunity may last, saying, “experts do not yet know how long you are protected from getting sick again after recovering from COVID-19.” So, they conclude, everyone must be vaccinated, even those who have recovered from COVID-19.
Simple enough, yes. You will find this theory repeated on health websites and in the popular press, often citing compelling studies and medical experts.
But does it make sense? Before the pandemic, did medical science ever assert that vaccine-induced immunity is superior to natural immunity? I’ve looked. I cannot find that assertion from any reputable source, nor can I find that assertion supported by any body of evidence. I’m not saying that I’ve looked everywhere. I’m saying I looked and came up empty. If you know where it is, please tell me.
Let me be clear about my question. I’m not doubting that vaccine is an important tool in the war against infections generally and SARS-CoV-2 specifically. Clearly, vaccines provide protection to individuals most vulnerable to bad disease outcomes. Clearly, vaccines raise the overall immunity within the population, stemming the spread of infection. An article published in Texas Medicine on the eve of the pandemic advocates for vaccine, especially childhood vaccines—mumps, measles, rubella, and the like—using a simple risk-benefit analysis. This analysis, and many more like it within the body of traditional medical science, compare the risk of vaccine to the risk of disease. Acknowledging that vaccines have risk and diseases have risk, vaccines generally have less risk than disease. This is very different from introducing the risk of vaccine to individuals who have already survived the risks of infection by the virus.
There is a glaring flaw in the CDC’s argument. True enough, experts do not yet know how long you are protected from getting sick again after recovering from COVID-19. But neither do experts know how long you are protected from getting sick after completing a vaccine series. How could they know either? Neither COVID-19 nor the vaccines have existed long enough to be studied meaningfully, which brings me back to my question. How can we say vaccine-induced immunity is superior to natural immunity?
I cannot think of any other example of this line of thinking. We do not insist that children who have had chicken pox get the chicken pox vaccine. We do not give hepatitis B vaccine to individuals who have had hepatitis B infection. In fact, before giving a hepatitis B vaccine, we usually test for antibodies to make sure the individual has not been previously infected. Why expose someone to an additional risk unnecessarily?
Are COVID-19 vaccines different from any other vaccine? Has a new theory of immunology suddenly replaced years of observation and wisdom? Why would the CDC, a place I know to be filled with smart, dedicated, and sincere physicians and scientists, be so insistent that COVID-19 survivors be vaccinated?
If you know the answers, please tell me. I would love to hear from you.
- New Clotting Disorder Caused by Vaccine
We’ve already discussed the rare clotting disorder associated with COVID-19 vaccinations, resulting in the pause of the Janssen vaccine last month. It’s time to take a deeper dive to understand more about this disorder. To start, we must learn a little about platelets. It’ll be quick, I promise.
Platelets are bits of cells that circulate in the blood stream looking for leaks. When a leak is found, platelets are activated and clump together to plug the hole. There are lots of platelets in blood, so one hole usually isn’t enough to reduce the platelet count. However, if all the platelets are activated at once, many clumps form, and the count of platelets goes down dramatically. The reduction of platelet count is called thrombocytopenia. “Thrombocytes” means “platelets” and “penia” means “not enough”, so “thrombocytopenia” simply means “not enough platelets”.
Heparin induced thrombocytopenia (HIT) is a condition in which platelets are activated after the use of heparin, causing a suddenly drop in platelet count. This is particularly dangerous because, as you may recognize, heparin is a “blood thinner” given to dissolve clots. The formation of many clots is the opposite of what is desired. HIT occurs because of an immune response in which antibodies to a molecule that forms when heparin is injected cause activation of platelets throughout the body. The molecule is called “heparin-platelet factor 4 complexes,” but the name doesn’t matter. Most people don’t have those antibodies to this molecule. This is a rare but life-threatening complication of heparin therapy.
The rare clotting disorders that have been rarely been observed after the Janssen vaccine have a similar mechanism. Now referred to as vaccine induced thrombotic thrombocytopenia (VITT), it is like HIT because antibodies develop after vaccine administration that cause platelet activation. The antibodies are similar enough to HIT antibodies that giving heparin will make the clots worse. This is why heparin cannot be used to break down those clots.
This seems to be the same clotting complication that has been observed with the AstraZeneca COVID-19 vaccine, not available in the U.S., but widely available elsewhere. Both vaccines have in common the use of an adenovirus vector to deliver the vaccine. A viral vector is not used in the mRNA vaccines. Is VITT related to the adenovirus vector in some vaccines? Nobody knows for sure. Yet.
This is another example of unintended consequences resulting from the use of systems still in the early stages of development. Life is full of risks; we accept that. But wisdom demands that risks be acknowledged, quantified, and mitigated as much as possible. Only the foolish follow science blindly.
- A Useful Model
Scientists create mental models to help understand the world around us. Not that these models are reality; the real world is much, much more complicated. Instead, these models are useful ways to think about reality. Today I would like to create a mental model of the SARS-CoV-2 virus that will be useful as we learn more about the virus in coming weeks and months.
Think of the virus as an egg with spikes driven into the shell. Now focus on two parts of this model: the spikes and the yolk inside the egg. The spikes correspond to the S-proteins on the outside of the virus. That’s easy to remember—S for spike. The yolk corresponds to the nucleocapsid that covers the genetic material on the inside of the virus. Let’s call the nucleocapsid “N” for short, which will also help us remember that N-proteins are inside the virus. Now in our mind’s eye we see a virus shell with S-proteins on the outside and N-proteins on the inside.
When foreign proteins show up in your body, your immune system responds by making antibodies. Therefore, when infected by SARS-CoV-2, your body will make at least two different types of antibodies: S-antibodies and N-antibodies. Blood tests are now available that can detect both kinds of antibodies, and both should be detected in someone who has been infected by SARS-CoV-2 in the past.
Vaccines expose the body to S-proteins only. N-proteins are not part of vaccines. Therefore, someone who has received a vaccine but has never been infected will have S-antibodies but not N-antibodies. S-antibodies may come from vaccine or infection. N-antibodies come from infection only.
Now we can use our model to predict antibody test results from four different groups of people, represented in the table below:
Previously Infected Never Infected Vaccinated S+ N+ S+ N- Unvaccinated S+ N+ S- N- A simple model, but does it work? To find out, I collected the results of antibody tests from four groups of people: people infected but not vaccinated, people vaccinated but not infected, people vaccinated and infected, and people never infected nor vaccinated. Next time, we will review the results.
- Antibodies after Vaccination and Disease
Last time, we built a mental model of the SARS-CoV-2 virus and used that model to make predictions of antibody test results. This time we will see how that model squares against real-world observations.
Here’s the table we created last time:
Infected Uninfected Vaccinated S+ N+ S+ N- Unvaccinated S+ N+ S- N- With their permission, I tested more than 40 individuals who fit into one of the four categories. Here’s what I found:
Infected Uninfected Vaccinated 4 S+ N+
7 S+ N-17 S+ N-
3 S+ N+Unvaccinated 4 S+ N+
2 S+ N-4 S- N-
2 S+ N+Previously Infected and Vaccinated. There were eleven people in this category, but only 4 had both the S- and N-antibodies that our model predicted. Surprisingly, nearly two thirds of the people in this group lacked N-antibodies. This is not what our model predicted. It seems some people may not form N-antibodies. Let’s keep looking.
Previously Infected but Unvaccinated. There were six people in this category. Four had both S-antibodies and N-antibodies, but two had only S-antibodies. Again, we’re missing some of the N-antibodies predicted by our model. What’s going on here? I’ll offer some speculations later.
Vaccinated without Known Infection. There were twenty people in this category, and all but three of these individuals had the expected S+ N- antibody pattern. All outliers were S+ N+, suggesting they had asymptomatic infections sometime during the pandemic. Is this suggestion reasonable? I think so. During the pandemic we tested healthy patients before elective surgeries and found a significant number of asymptomatic infections, so we know this can happen.
Unvaccinated without Known Infection. There were initially five people in this category, and they had neither S nor N antibodies detected in their blood. Except for one person. She was surprised to learn she of a silent previous infection based on the finding of both S and N antibodies in her blood. Subsequent testing of her husband, who also is unvaccinated without previously known infection, found S and N antibodies in his blood too, bringing the total number of people in this group to six with two outliers.
We can summarize what we’ve learned as follows:
- Both SARS-CoV-2 infection and vaccine stimulate the production of S-antibodies, 100% of the time in this study.
- A significant number of people, about 20% in this group, had silent SARS-CoV-2 infections during the pandemic.
- SARS-CoV-2 infection does not seem to stimulate the production of N-antibodies consistently. This is a pesky observation that does not fit our model.
Could it be that N-antibody production relates to the severity of disease? Probably not since quite a few of the S+ N+ individuals in this study had asymptomatic infections. Could it be that variant viruses cause N-antibody negative infections? Or is the N-antibody test not very good? All are possible, but, as we’ve said so many times since the outbreak of the pandemic, we really don’t know for sure. What we can say is that tests for “COVID antibodies” are more complicated than they seem at first glance. Laboratories should clearly label the antibodies measured when reporting SARS-CoV-2 antibody results.
How do the antibody levels caused by disease compare with the antibody levels caused by vaccine? And which vaccine provides the best immune response? We will examine these questions next time.
- THE PANDEMIC IS OVER
What gives a Texas pathologist practicing in a suburban community the right to declare THE PANDEMIC IS OVER in screaming headlines? Shouldn’t such a pronouncement come from an official institution like the NIH or the CDC or the WHO or a prestigious university? Read on, I’ll tell you.
The graph of the number of positive tests resulted each week by the laboratory where I practice gives you a fair image of the pandemic in my community:
There were two waves, a small one last summer and a bigger one in the winter. But since the end of February, the number of positive tests has been low and constant. Positive tests have not disappeared, but the rate of positives is not changing. Search for rates in your community, and I bet you’ll find a similar graph.
Recall that epidemic means an increasing number of cases in a community, and that pandemic means an epidemic all over the world. From the graphs it’s obvious that the number of cases is not changing, and it hasn’t been for several months. If there’s no epidemic in my community and there’s no epidemic in your community, then there’s no more pandemic. The pandemic is over.
The graphs also tell us that the virus is still here, and probably will be for a long time, maybe forever. Epidemiologists call this the endemic rate—the rate of disease that is always present in a population. People will still get sick, and some may even die, but it’s no longer an epidemic. We reached herd immunity more quickly than many “experts” predicted.
So now what? We have to learn to live with the virus. Know your immunity status. If you are not immune, continue COVID precautions if you wish to avoid contracting the virus. The pandemic may be over, but the virus and its variants will be with us for a long time.
- Vaccinate the Previously Infected? A Risk without Benefit
Vaccination of the previously infected is a risk without benefit because there’s no significant difference between S-antibody levels stimulated by SARS-CoV-2 infection when compared with vaccine.
Using the same group of volunteers from our study to determine antibody types stimulated by vaccine and/or COVID, we measured the level of S-antibodies in the people who had them. To make the comparison fair we did not consider the people who were both vaccinated and infected; instead, we only counted people who were vaccinated but had no evidence of disease, and we compared them to unvaccinated people with evidence of infection. Here’s what we found:
Individuals Low High Average Vaccine 17 1.4 9.1 6.6 COVID 8 1.2 8.3 4.2 There were 17 people vaccinated without disease. Their S-antibody levels ranged from 1.4 to 9.1 with an average of 6.6. There were 8 unvaccinated individuals with evidence of infection. That evidence could with be a positive SARS-CoV-2 test sometime during the pandemic, a positive N-antibody test, or both. Their S-antibody levels ranged from 1.2 to 8.3 with an average of 4.2. Any level above 1 is considered positive.
Graphically, the data looks like this:
Give a slight edge to vaccine, but really the difference between the two groups is negligible. The COVID group includes a couple who previously had asymptomatic infections, implying that even asymptomatic infections cause the formation of S-antibodies just like vaccines.
Which causes us to return to the question we asked in early May. Why vaccinate COVID survivors? I still see no evidence for doing so, but there are reasons for not vaccinating previously infected people. Our study includes two previously infected people who took the first dose of an mRNA vaccine and experienced vaccine complications so severe that they couldn’t take the second dose. One of the two developed a debilitating condition that has not yet resolved and may persist for life. Through June 7, 2021, VAERS received 5,208 reports of death associated with vaccine administration in the U.S. Clearly the vaccine did not cause every reported death, but just as clearly, the vaccine death rate is greater than zero. Death is the most serious of complications. There are more common but less serious complications that range from inconvenience to discomfort to debilitation. If there is no benefit, why take a risk? That’s why my advice is that previously infected people should not be vaccinated without a compelling personal indication.
Some researchers are beginning to agree with me. As early as February, a study subsequently published in Nature suggested that a second dose of mRNA vaccine is unnecessary for people previously infected by SARS-CoV-2. More recently, a pre-publication report of a study conducted at the Cleveland Clinic concludes that vaccinating individuals who have had SARS-CoV-2 infections has no benefit.
So why does the CDC still adamantly insist that COVID-19 survivors be vaccinated? The answer lies in perspective. The vaccination rate in a community is the single greatest factor in controlling the spread of disease and achieving the goal of herd immunity, which has already been reached in many parts of the country. If you prioritize the good of the population over the good of any individual, then you advocate for universal vaccination even when the vaccine has no benefit, or worse yet, may cause harm to individuals.
That is not my focus as a physician. My focus is the individual, the patient in front of me. Health care is not a commodity that can be mass-produced without hurting individuals. I have urged that vaccine decisions be made individually, not collectively, and I continue to do so. I believe that the people with greatest risk of unnecessary harm from vaccine are the previously infected and the young.
The suggestion that even asymptomatic infections cause the formation of S-antibodies has implications in the ongoing debate regarding the vaccination of children, the group most likely to have asymptomatic infection. During this debate, we must first resolve whether our priority is the population as a whole or the individual boys and girls subject to vaccination. We may reach different conclusions depending on the priority we choose.
Here’s an idea. Why not check S-antibody levels before vaccination? Something to think about.
- The Delta Variant
The Delta Variant is one of several new strains of SARS-CoV-2 recently added the variant zoo. Why has this new variant received so much attention lately, and why are we referring to variants with Greek letters now?
The CDC still groups variants into categories of High Consequence, Concern, and Interest. Thankfully, there are still no Variants of High Consequence. The WHO has assigned Greek letters to certain variants to aid in communication. The Delta Variant, B.1.671.2, is a new entry on the list of Variants of Concern. Three cousins of the Delta Variant, B.1.671, B.1.671.1 and B.1.671.3 are now on the Variants of Interest list. All these new strains originated in India.
What makes Delta different? It’s the first addition to the Variant of Concern list since April, and it’s prevalence in the U.S.is increasing. Although it’s not nearly as prevalent as the Alpha Variant, aka the U.K. Variant, B.1.1.7 which we first learned about last December, some reports suggest that the Delta Variant is even more easily transmitted, meaning that it may soon replace the Alpha Variant as the most common form in the U.S. The Delta Variant shows some resistance to treatments, although not more than other variants. It does not escape detection by tests, and S-antibodies, either from disease or vaccine, seem to provide immune protection. The Delta Variant is just the ‘new kid on the block’; we need to take this in stride.
I’ve updated variant reference tables, sorted by U.S. prevalence.
Variants of Concern Variant WHO Label First Detection Current U.S. Prevalence Increased Transmission Increased Severity Reduced Detection by Tests Resistance to Treatment B.1.1.7 Alpha UK 69.7% 50% ● P.1 Gamma Japan/Brasil 8.4% ● B.1.617.2 Delta India 2.7% 140% ● B.1.351 Beta South Africa 0.7% 50% ● B.1.429 Epsilon California 0.6% 20% ● B.1.427 Epsilon California 0.4% 20% ● Variants of Interest Variant WHO Label First Detection Current U.S. Prevalence Increased Transmission Increased Severity Reduced Detection by Tests Resistance to Treatment B.1.526 Iota New York 5.0% ● B.1.526.1 New York 2.5% ● B.1.525 Eta UK/Nigeria 0.1% ● B.1.617.1 Kappa India 0.1% ● P.2 Zeta Brazil 0.0% ● B.1.617 India 0.0% ● B.1.617.3 India 0.0% ● - Which Vaccine Causes the Greatest Antibody Response?
It’s not even close. In terms of generating the highest S-antibody response, Moderna is the clear winner. Pfizer comes in second, and Janssen (Johnson & Johnson) finishes in last place. Here’s the data that backs this up.
The same volunteers we tested to figure out antibodies after vaccination and disease were separated by vaccine type and evidence of infection. Evidence of infection includes either a positive SARS-CoV-2 test during the pandemic or the unexpected presence of N-antibodies. We did not count two individuals who had only one dose of mRNA vaccine, nor did we include people who had both vaccine and infection. Then we measured the antibody levels of the individuals in each group. Here’s what we found:
Vaccine Low High Average Moderna 8.4 9.1 8.7 Pfizer 4.2 7.6 6.2 Janssen 1.4 3.9 2.6 Clearly, Moderna vaccine stimulates the highest antibody response. Then we graphed the antibody response caused by vaccine compared to the immune response of infection.
Previous infection is better than the Janssen vaccine and nearly as good as the Pfizer vaccine. If we eliminate those overachieving Moderna people, we get a chart that looks like this:
Immunity Source Low High Average Pfizer or Janssen 1.4 7.6 6.2 COVID 1.2 8.4 4.3 Graphically, the data looks like this:
It’s nearly identical.
Let me summarize the findings and restate the question that’s been puzzling me for weeks. Two of the three vaccines authorized in the U.S. stimulate S-antibody levels that are no better than SARS-CoV-2 infection. Yet the CDC still insists that infected individuals be vaccinated with any of the three authorized vaccines, even if the person starts out with S-antibody levels at least as high as the expected levels resulting from vaccination. Why?
Let me be clear. I’m not asking whether a person who has not had COVID should be vaccinated. That’s a legitimate question that deserves more than knee-jerk consideration, but it’s not the question I’m asking here. I’m asking why vaccination is in the best interest of a person who has already been infected? Maybe the answer is obvious to you; if so, please help me understand. It doesn’t make sense to me.
Last time, I asked you to consider that the answer may be in the prioritization of population health over individual health. This time I ask you to consider something else. When things don’t make sense to me, I have a snarky, cynical side that asks, “Who’s profiting?”
Something to think about.
- More Vaccine Complications
We have warned of the dangers of unforeseen consequences inherent in medical therapies and procedures that have not been thoroughly tested. All COVID vaccines are in this category since they are only available in the U.S. are under Emergency Use Authorization. None has been approved by the FDA.
Information about vaccine complications is slowly emerging. First, we learned of the 10x higher incidence of anaphylaxis from mRNA vaccines compared to other vaccine types. Then we learned of a new clotting disorder caused by vaccine called VITT. Last week, the FDA required a new statement in Pfizer and Moderna Factsheets for Healthcare Providers warning that certain cardiac disorders, including myocarditis and pericarditis, may be caused by mRNA vaccines.
In the pathology world, adding “-itis” to the end of a word simply means inflammation. So, myocarditis is inflammation of muscle (“myo-”) of the heart (“card”), and pericarditis is inflammation of the sac around (“peri-”) the heart. By themselves these words are vague and do not say what that inflammation means to a person. Myocarditis can be mild and go away on its own, or it can be severe and cause the heart to stop beating. Similarly, mild pericarditis is a common finding in many disease processes, but pericarditis can become so severe that it restricts the movement of the heart, a condition called “cardiac tamponade” which can be deadly.
These vaccine complications tend to occur in young people who receive mRNA vaccines (Pfizer and Moderna, but not Janssen), especially when there is an underlying cardiac condition. The trouble is that this vaccine complication may be the first sign of an underlying cardiac condition, since “in this younger population, coronary events are less likely to be a source of these symptoms.” Does this make the vaccine unsafe for adolescents and young adults? The CDC says no; I’m not so sure.
It’s noteworthy that none of these complications—not anaphylaxis, not VITT, and not inflammatory heart conditions—were included in data submitted to FDA for initial authorization. We are learning as we go. Quite literally, if you take a COVID vaccine, you are part of a study of the long-term effects of that vaccine on humans. There may be compelling reasons for a person to take a vaccine, ranging from personal health benefits to scientific altruism. But just as compelling may be the reasons a person chooses not to take a vaccine. We should not coerce these decisions, we should not ridicule these decisions, and we should not penalize individuals for these decisions.
We simply don’t know all the long-term consequences of the COVID vaccines. But if history is any guide, there will be unintended consequences that may make the “smart people” of today look foolish in the future.
- COVID and Autoimmune Disease
Some individuals infected by SARS-CoV-2 experience brain damage. Although it sounds like science fiction, “COVID brain fog” describes a very real condition in which infected patients experience memory loss, strokes, and other nervous system lesions. How can this happen?
In an article published last week in Nature, Michael Marshall, a free-lance science journalist from the U.K., describes the current areas of research into the causes of this condition. One possible mechanism is autoimmune disease.
The immune system’s job is to protect the body from agents of disease (“pathogens”) without damaging the body’s own cells. Like the military guarding the border of a sovereign nation, the constituents of the immune system carry lethal weapons meant to destroy an invading enemy. But what if the military can’t tell the difference between friend and foe? Those lethal weapons might be unleashed on its own people, and the citizens of that nation would be at risk of harm from their own government. Let’s say for example that the U.S. learned all its enemies wear red hats. If the army was ordered to seek and destroy anyone wearing a red hat, many innocent Americans unwittingly wearing red hats could be killed in an effect to stamp out a threat to our nation.
The immune system works by learning something about the pathogens that threaten the body—not the color hats they wear, but the shape and composition of molecules on the invaders. When the shape and composition of those molecules are similar enough to the shape and composition of molecules on the cells in our own body, the immune system can’t tell the difference, and it attacks us. That’s autoimmune disease.
Autoimmune disease is highly individualized. Although we lump these diseases into categories ranging from lupus to rheumatoid arthritis, each person with an autoimmune disease has a disease that’s uniquely his or her own. There’s a lot of overlap, but no two individuals have exactly the same disease manifestations.
There are many examples of autoimmune disease targeting specific organs. Hashimoto’s thyroiditis is a disease in which the immune system targets the thyroid gland. In Crohn’s disease the immune system targets the cells of the gastrointestinal tract. Multiple sclerosis is an autoimmune disease of the central nervous system. COVID brain fog may also be, at least in part, an autoimmune disease of the central nervous system in which an immune system primed to destroy SARS-CoV-2 causes collateral damage to the brain.
If that’s the case, we have yet another reason to avoid COVID-19. But we may also want to avoid stimulating the immune system to fight SARS-CoV-2, which is precisely the goal of a COVID vaccination. We know that everyone who has had COVID-19 develops antibodies to the viral spike protein. We also know that everyone who has received a COVID vaccine develops antibodies to the same viral spike protein. What if these are the autoantibodies associated with COVID brain fog?
Although there is no proof this is the case, there is evidence suggesting that the idea is plausible. Last week, we learned that vaccines may cause myocarditis and pericarditis, essentially an autoimmune disease affecting the heart. VITT, a condition in which vaccination causes blood clots, is also immune mediated. We must consider the possibility that stimulation of immunity against viral spike proteins causes autoimmune disease in some vaccine recipients.
As we connect more dots, an image emerges from the haze of the pandemic. As the picture becomes clearer, will we have the courage to believe what we see?
- A New Vaccine Warning: Guillain-Barré Syndrome
Last week, the FDA added a new statement to the Janssen vaccine Factsheet for Healthcare Providers, warning of an increased incidence of Guillain-Barré Syndrome among vaccine recipients. This warning was issued after cases in India and the United Kingdom were published in the Annals of Neurology. Although the warning only applies to the Janssen vaccine, at least one case has also been reported following Pfizer vaccination.
Guillain-Barré Syndrome is a condition in which the immune system attacks peripheral nerves, the nerves responsible for sending signals for motion and sensation between the body and the brain, resulting in pain and weakness, and in severe cases, paralysis and death. Although most people recover, symptoms may linger for a long time. Guillain-Barré Syndrome is triggered by various conditions that cause inflammation, including infection, surgery, trauma, and cancer. Rarely influenza and childhood vaccines have been associated with Guillain-Barré Syndrome.
Guillain-Barré Syndrome was identified as a complication of COVID-19 early in the pandemic. Subsequent studies demonstrate that these cases are “not due to a direct attack of the virus, but rather to an immunological reaction to the virus.” Now we learn this long-recognized complication of COVID-19 can also be an adverse effect of a COVID vaccine.
The warning for Guillain-Barré Syndrome is the third FDA statement of an immune mediated vaccine complication, adding to the precautions previously issued for myocarditis and clotting disorders. Interestingly, myocarditis and clotting disorders have also been recognized as complications of COVID-19.
It’s becoming increasingly clear that COVID-19 has two separate disease pathways. The first is the direct effect of the virus. The second is the response of our immune system to the virus. Vaccines intentionally stimulate this immune response. Is it surprising that adverse vaccine effects overlap with COVID-19? Expect more examples of autoimmune complications of COVID vaccines.
- A Pandemic of the Unvaccinated?
During a White House press briefing last week, Dr. Rochelle Walensky, the director of the CDC, declared, “This is becoming a pandemic of the unvaccinated.” She continued, “And our biggest concern is that we are going to continue to see preventable cases, hospitalizations, and, sadly, deaths among the unvaccinated.” Is there a rational basis to allow our war against the pandemic to devolve into a fight between vaccinated and unvaccinated citizens? In this blog, I will use data found at the CDC’s website to outline what we know and what we don’t about vaccinations, infections, disease, and death.
What we know:
- SARS-CoV-2 infections have increased recently. It’s easy to see this point from the CDC’s COVID Data Tracker. Play with the graph a little. By clicking any of the boxes (sex, age, ethnicity) under “Cases” on the upper left, you’ll see case trends of the entire pandemic. Pass your cursor along the horizontal axis, and you’ll see the rate of cases each week of the pandemic. The number of cases bumped up in the first two weeks of July. But the recent increase is not yet close to levels of the surge last winter.
- Deaths from COVID-19 are still going down. Using the same graph, click on any of the boxes under “Deaths” on the upper right. The last week deaths increased was May 8, and then only by a little bit. There has not been a spike in COVID deaths since the winter surge. Even as infections increased recently, deaths have not.
- Risk of death from COVID-19 increases with age. Now look specifically at deaths by age. Move your cursor along the horizontal axis and pay attention to the death rate as age increases. It’s the old who die from COVID-19, not the young.
- Vaccination rates are highest among those at greatest risk of death from COVID-19. Now study another chart from the CDC’s COVID Data Tracker. Notice that in increasing age groups, more and more people are at least partially vaccinated, more than 90% among 65–74 year-olds. The old, who have the greatest risk of death from COVID-19, also have the highest vaccination rates.
- Vaccination does not prevent COVID-19. Breakthrough cases occur, and vaccinated individuals can spread the disease. This last point is well known by everyone who follows Texas politics.
- Community vaccination rates correlate with reduction in COVID-19 spread. For this point, study the CDC’s vaccination vs. covid heat map, showing lower rates of COVID-19 where vaccination rates are higher and vice versa. This is the data Dr. Walensky points to when saying “This is becoming a pandemic of the unvaccinated.” However, unless she has private data not on the website, I do not see a similar correlation between deaths or even hospitalizations. Death rates continue to decline, even among the unvaccinated.
- Vaccination is associated with significant adverse effects, including death. Guillain-Barré Syndrome, inflammation of the heart, blood clots, anaphylaxis—and these are just the labelled complications. Expect more immune-mediated vaccine complications to emerge in the future.
There are some things we don’t know, and we don’t know them because we don’t yet have good data. For example, the CDC tracks COVID-19 deaths by sex, age, and ethnicity, but not by vaccination status. That information would be very helpful to individuals deciding whether to take a vaccine. So would age-adjusted vaccine complication rates. The absence of such data makes it difficult-to-impossible for young people to determine their personal risk-benefit ratios for vaccination. The VAERS website is good for its intended purpose as a reporting site for adverse events, but the data must be mined and analyzed to be meaningful.
Good data is simply hard to come by. Last week, Sir Patrick Vallance said in a press conference that 60% of hospitalized COVID-19 patients in the UK are fully vaccinated. Later, he tweeted a correction, saying exactly the opposite. The trouble is that it’s impossible to validate either statement with reliable, publicly available data.
Science is a process, not a product. For science to work, conventional wisdom must be questioned. It is always okay to ask, “Why should I believe this?” Dissent is a natural byproduct of science. But dogmatism, coercion, ridicule, hyperbole, and fearmongering have no place among real scientists. Not even the director of the CDC.
- Staying Alive
If anything is sacred, the human body is sacred.
― Walt Whitman
How should we define victory in the war on the pandemic? My vision may surprise you. I think our objective should be not dying. Death rates should be our success metric, and the preservation of our institutions and freedoms our goal. We can accomplish this by making smart individual decisions, not sweeping collective ones. We cannot allow our society to be fractured into camps of the vaccinated and unvaccinated.
The universal vaccination mandates sweeping across our nation now are more dangerous than the current wave of SARS-CoV-2 infections. Don’t believe me? Check out the CDC’s COVID Data Tracker. Deaths from COVID-19 are at their lowest levels since the pandemic began. Yet on pain of job loss, we are pushing vaccines into the arms of our young who have the most to lose and least to gain.
Don’t get me wrong. Vaccination is an important tool in our effort to save people from dying of COVID-19. Those at greatest risk—the old, the obese, the diabetics—should strongly consider vaccination for their own safety. Vaccines also reduce the spread of COVID-19 within a community. When vaccines became available in late December, community infection rates declined as vaccination rates went up. But that doesn’t mean that vaccination is in the best interest of every individual.
Wait, I hear you say, we must vaccinate everybody to contain breakthrough and stop the spread of the virus. Especially hospital workers—I want to know that people taking care of me are vaccinated so they won’t make me sick. Nice theory, but where’s the data that supports the idea that vaccinated people can’t make you sick, that vaccines contain breakthrough and stop the spread of the disease? I’ve looked; I can’t find it. If you have it, please share it with me.
I see data that supports the opposite theory. In last Friday’s Morbidity and Mortality Weekly Report (MMWR), the CDC reported a SARS-CoV-2 outbreak in a highly vaccinated community. Some were shocked to learn that three-quarters of these cases occurred in fully vaccinated individuals, that the viral loads between vaccinated and unvaccinated individuals were identical, and that four out of five patients sick enough to be hospitalized were fully vaccinated. This report supports one of the points made last week: vaccination doesn’t prevent COVID-19. Breakthrough cases occur, and the vaccinated can spread the virus. Universal vaccination will fail as a containment strategy.
But, you persist, we have to vaccinate everybody before new variants emerge that will be even more dangerous. After all, you say, 90% of the virus in the reported outbreak were delta variant. True, this outbreak was mostly delta variant, but delta variant is now the dominant variant in the U. S. because of its higher transmissibility, just like alpha variant replaced original SARS-CoV-2 earlier in the year. Where is the evidence that universal vaccination prevents formation of more dangerous variants? Again, I’ve looked, and I don’t find it. If you have it, please share it with me.
Infectious disease orthodoxy says the opposite. Indiscriminate use of anti-biologic agents pressure pathogens to mutate, increasing their virulence. Doctors are reprimanded for treating viral illnesses with antibacterial agents (“antibiotics”) because they have potential for more harm than good. The same is true for vaccines designed to prevent infections by viruses that easily mutate. That’s one reason we don’t have vaccines for the common cold—the target moves too quickly, and infection is not that dangerous to most people. Universal vaccination will fail to prevent emergence of variants.
If universal vaccination becomes our objective in the war against the pandemic, deaths may increase, surges may continue, and more dangerous variants may emerge, but won’t we feel good about our vaccination rates? The pandemic has an enemy; it’s not the unvaccinated.
There is another way. Allow doctors to make individualized decisions for treatment and vaccination in the best interest of each patient. If we do all we can to help those at risk, deaths will continue to go down. The virus may never go away, but we can learn to live with it. We can also preserve our institutions and freedoms, and we can stop dividing people. We can stay alive.
- Updates, Questions, Present, and Future
A lot changed in pandemic landscape last week. This blog outlines those changes and highlights important unanswered questions.
- The surge of delta virus infections continues across the country. Several weeks ago, I announced that the pandemic is over. That statement requires revision. Maybe the pandemic of alpha virus was over then, but the epidemic of delta virus is here now. Delta virus is the overwhelming variant in the U.S. with parts of the country (Florida, Hawaii, and Louisiana) experiencing their highest cases of the entire pandemic.
- Deaths are up, but still low. Unfortunately, it’s no longer the case that deaths are at the lowest level of the pandemic. Deaths have increased with the current surge of delta virus. Although even one death is too many, it is reassuring to see that deaths are not at levels seen during the winter surge, and that deaths have increased at a lower rate than infections during the current surge. As with the previous two surges, older individuals are at great risk than younger individuals. Based on data from the CDC COVID Data Tracker, COVID-19 deaths per ten million Americans during the week of July 24, 2021, were:
- 2 for individuals between 18 and 29 years-old
- 5 for individuals between 30 and 39 years-old
- 14 for individuals between 40 and 49 years-old
- 22 for individuals between 50 and 64 years-old
- 39 for individuals between 65 and 74 years-old
- 101 for individuals aged 75 years and older.
- New testing recommendations for COVID vaccinated individuals. The CDC has changed its testing recommendations for vaccinated individuals who have had an exposure to someone with SARS-CoV-2 infection. An exposure is still defined as contact of less than 6 feet for more than 15 minutes when one or both individuals are not wearing a mask. Before this change, COVID vaccinated individuals were asked to test only if symptoms developed. Now a SARS-CoV-2 test is recommended for COVID vaccinated individuals 3 to 5 days after the exposure, and the exposed individual should wear a mask indoors for up to 14 days until a negative result is obtained.
As individuals decide how to mitigate personal risk of death from COVID-19, the following information on the CDC COVID Data Tracker would help people make better decisions:
- Reinfection rates and deaths among previously infected individuals. Contrary to CDC recommendations, I believe vaccination of COVID survivors is a risk without benefit. We could know the answer for sure if cases and deaths in the CDC COVID Data Tracker were stratified by previous infection status. If unvaccinated people with previous infections have low infection and death rates, we could conclude that previous infection provides protection from COVID-19.
- Infection rates and deaths among previously vaccinated individuals. This data exists, but not on the CDC COVID Data Tracker. We could have a better understanding of the risk of breakthrough and serious disease if the CDC compiled and published this information beside the other important and helpful information on its website.
- Vaccination complication rates by age and severity. This information is essential to a risk/benefit analysis of COVID vaccination, but this data is especially difficult to compile for several reasons. First, not all adverse effects report on VAERS are truly vaccine related. Second, not all vaccine related adverse effects are reported on VAERS. Finally, not all adverse effects caused by vaccine are recognized as such. Delayed effects may never be flagged as vaccine related. It may take years to ever sort out this problem. The best we can do now is look at the vaccine warnings (see Pfizer, Moderna, Janssen), including the warning that “additional adverse reactions, some of which may be serious, may become apparent with more widespread use”. We must continue to expect unknown consequences.
We are in our second year of the pandemic, and we have some experience to help us understand what’s coming. The U.S. is experiencing its third surge of SARS-CoV-2 infections. The first surge was associated with the original form of the virus. The second surge coincided with the replacement of the original form by alpha variant. The current surge began as the wave of delta variant replaced alpha. Will it be the case that a surge will be experienced time a more infectious variant replaces its predecessor? Could be.
- Common Sense
As SARS-CoV-2 infections are increasing and some parts of the country are experiencing their highest rates of the pandemic, we face a medical shortage. In Texas, the supply of staffed hospital beds is shrinking, and some communities are out of ICU beds. Staffing shortages are becoming critical. Is this the time to fire doctors, nurses, and other healthcare professionals for refusing a COVID vaccine?
Many people feel sick after a COVID vaccination, and some of those people won’t be able to come to work. The Janssen vaccine isn’t fully effective for two weeks after the shot. It takes five weeks for Pfizer and six for Moderna. Meanwhile, hospitals are short on beds, and even shorter on staff. Which will save more lives—fully vaccinated healthcare workers or staffed hospital beds?
The healthcare community has managed COVID surges without vaccine before, and we can do it again. The universal vaccination of healthcare workers achieves no benefit that justifies the violation of individual liberty required to achieve this goal. You may disagree with me. We should have that debate.
But right now, those of us who work at hospitals have our hands full taking care of COVID patients. Can we talk about this later?
- Vaccination Card Folly
Do Vaccination Cards Keep Us Safe?
Before I answer that question, I’d like to tell a personal story. I took a single dose Janssen vaccine March 15, 2021. I measured my spike protein antibodies on May 20 to make sure that the vaccine worked; my test was positive with an index level of 1.4. Last Thursday, August 12, I measured my antibodies again. They were negative. I have a vaccination card that I can use to sit in a New York City restaurant, attend a concert at SFJAZZ, live on a university campus, or work at a hospital that has mandated vaccines. Even if H.R. 4980 becomes law, I will be able to travel on an airplane in the United States. Yet not even five months since my vaccination, there is no longer evidence of antibody-based immunity in my blood.
My story is another example of the folly of making universal vaccination the primary objective of the pandemic response. Vaccine mandates by restaurants, employers, airlines, colleges, and entertainment venues are based on the flawed assumption that vaccinated people are safe, clean, and not dangerous to others. There is undeniable evidence that breakthrough infections occur, that the vaccinated can spread the disease, and that vaccinated individuals can die of the disease. It’s becoming clear that eradication is no longer possible.
There is also mounting evidence that vaccines are associated with significant side effects that affect the health and wellbeing of individuals. Expect more evidence to emerge. We do not yet know the whole story.
I don’t have all the answers—nobody does. Our understanding of both the virus and the vaccines are so far from complete that it’s impossible for anyone to make sweeping recommendations, no matter their position, no matter their intelligence. But there is one thing we know for sure. Clear objectives drive sound decisions. Before we can win this war, we must agree on a sensible objective.
Our desired outcome should be keeping as many people alive as possible. The life, health, and wellbeing of all individuals are paramount. When we give primacy to vaccination status, we lose sight of our noble objective, and we divide people into uncooperating groups. To the extent that vaccines further our objective, we should use them. To the extent that early treatments further this objective, we should use them. To the extent that therapies and treatment protocols have not been fully studied by science, we should fund studies publicly. Although we can count on the free market to sponsor research when there’s the prospect of a large profit, wouldn’t it be a shame to overlook regimens that can keep people alive just because there’s no money to be made? But we should never confuse any of these tools with our primary objective. We must allow people to make choices, and we must allow doctors to make personalized decisions in the best interest of individual patients.
Eradication is no longer possible, but survival is. We must learn to live with the virus. Have faith. Have courage.
- Vaccine Mandates Are Wrong
I’ve argued that vaccine mandates are the wrong objective at the wrong time. In this article, I want to convince you that vaccine mandates are just plain wrong. Wrong—as in the opposite of right. That kind of wrong.
Wait, you say. The name of the website is BetterPathology.com. What gives a simple practitioner of pathology the right to lecture us on right and wrong?
Medical ethics is part of every physician’s education and training. There are gray areas to be sure, but there are also bright lines that separate ethical from unethical practice, and every doctor knows where these lines are. Every physician knows the elements of informed consent, and every doctor understands why the Tuskegee experiments were wrong. There are aspects of vaccine mandates that should be troubling to all ethical physicians and all ethical Americans.
To the extent they are able, patients must participate in medical decisions. Informed consent requires a doctor to explain in understandable language the risks and benefits of a recommended treatment, the risks and benefits of alternative treatments, and the risks and benefits of doing nothing. It’s one thing to recommend the risks of a therapy when a patient’s natural disease leaves no other options. It’s quite another thing to recommend a vaccine when the most significant consequence of refusal is job loss. Threatening a young person to accept the risks of vaccine against his will smacks of Don Corleone’s “offer he can’t refuse.” Coerced consent is unethical.
Once we lose the freedom to evaluate and choose risks for ourselves, we lose the liberties at the foundation of our nation. When vaccines are mandated by a government or an employer, the right to choose what we want to put in our bodies is taken away from us. When we lose this liberty, how long until we also lose the freedom to associate with those we wish, to worship as we please, to speak our minds, or to choose which path we wish for our lives?
Vaccine mandates stigmatize dissent and erode individual liberty, separating society into vaccinated people and unvaccinated people. The vaccinated will have freedoms while the unvaccinated will be denied freedoms. Vaccinated individuals will have the freedom to eat at any lunch counter; unvaccinated folk will be seated outside in the back. The vaccinated will be able to watch the ballgame from box seats; the unvaccinated will be forced into designated sections in the outfield. There will be separate water fountains for vaccinated people and unvaccinated people. There will be separate entrances into public establishments. Vaccinated people will have unlimited job opportunities while the unvaccinated will find employment prospects limited. The vaccinated will enjoy unrestricted travel in the mode and style of their choosing; the unvaccinated will have to ride in the back of the bus, partitioned by a plexiglass shield. Ethical Americans, like ethical physicians, know the immorality of this type of irrational segregation which is based on the false premise that only the unvaccinated can make others sick.
There have been some ugly chapters in our history. Let’s not write a new one.
- What FDA Pfizer Approval Means
Today, the FDA approved the Pfizer COVID vaccine. This vaccine is the first of the three vaccines authorized under EUA to achieve this status. In this blog, I’ll highlight what this approval means. Obviously, this is just a first look at the information released by the FDA today. I’ve not studied the Full Prescribing Information in detail. There may be more changes that I have overlooked; I will update you on these as they become apparent.
First, let’s talk about what hasn’t changed.
- The vaccine has not changed. There have been no modifications to the vaccine. The vaccine that was injected before approval is the same as the vaccine given after approval.
- The warnings on the vaccine label have not changed. The Highlights of Prescribing Information issued with the vaccine approval have the same warnings that were listed for the pre-approval vaccine. These include acute allergic reactions (anaphylaxis), myocarditis and pericarditis, syncope (fainting), altered Immunocompetence, and limitation of effectiveness. Furthermore, Pfizer does not assure the safety of the vaccine in pregnancy or breast-feeding mothers.
- Vaccine experience is still limited. Although Pfizer updated its clinical trial data to include many more patients, and has expanded the observation period over more time, there are still no long-term clinical trials to study potential adverse effects this vaccine may have three, five, or ten years down the road.
So far, not much difference. What has changed?
- The vaccine is now called “COMIRNATY”. If anyone understands why they chose this name, please let me know. It’s not obvious to me.
- Approval does not include 12-15 year-olds. On May 10, the EUA for Pfizer vaccination was amended to include children down to 12 years of age. This vaccine is now approved for individuals 16 years and older. Children aged 12-15 may still receive the vaccination under a new reissued EUA.
- Removal of statement warning of unknown future risks. The previous Fact Sheet for Healthcare Providersincluded the following statement: “Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.” This statement is not present in the Highlights of Prescribing Information issued with this approval. However, the Fact Sheet for Recipients and Caregivers still contains the following statement: “These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.”
- The Pfizer COVID Vaccine is no longer “unapproved”. This may not seem like much of a substantiative change, but the psychologic and motivational effect of this change will likely be significant. Those advocating vaccine resistance relished referring to COVID Vaccines as “experimental” because, technically, they were. Janssen and Moderna still are. You can’t call the Pfizer COVID vaccine “experimental” anymore because, technically, it’s not. This semantic change will embolden governments and employers to pursue vaccine mandates.
But this brings us to a few more things that haven’t changed. I have argued that vaccine mandates are wrong strategically, wrong temporally, and wrong ethically. There is nothing about FDA approval of vaccine that changes my opinion on this. Ethical physicians have a duty to speak out on issues affecting patient safety, even and especially during a pandemic.
The FDA can and has made mistakes in its approval process before. It will again. It may have in this instance; time will tell. But if the FDA has bowed to political pressure to short-circuit this approval, the long-term consequences will be deadly. Not just to the health and wellbeing of vaccine recipients, but also to the trust that is the cornerstone of America’s healthcare quality.
According to the AMA Code of Ethics, individuals must participate in their personal healthcare decisions through the process of informed consent which requires complete, clear, and honest disclosures of all known and potential risks and benefits. Approved vaccines are not exempted from this moral obligation. An article published recently in American Journal of Law & Medicine, states that “to be autonomous, decisions need to be based on full, accessible information and reached without coercion.” No matter how well intentioned, coercion by government or employer cannot be part of informed consent process. Not in the Land of the Free. Not in the Home of the Brave.
- Did FDA Approve the Pfizer COVID Vaccine?
Yesterday’s FDA news release plainly says that the COVID vaccine that has been known as the Pfizer-BioNTech COVID-19 Vaccine has earned FDA approval and will now be known as COMIRNATY. So why were two letters issued by the FDA yesterday?
The approval letter, addressed to Amit Patel of BioNTech Manufacturing GmbH and delivered to Pfizer Inc. in New York, lists the conditions of approval, which include permission to the label the vaccine with the proprietary name COMIRNATY and permission to use the product to vaccinate individuals 16 years of age and older. The letter defers approval for use of the vaccine in individuals younger than 16 years of age, and it does not approve the administration of a booster shot.
On page 2, this letter states, “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.” The letter then continues to outline deadlines for the submission of a list of outstanding items, some of which might be considered controversial. Here are a few that caught my eye:
- A study to evaluate whether the vaccine can safely and effectively be administered in a lower dose to individuals 12 to 29 years of age, due in 2023.
- A study to evaluate the safety of vaccine in pregnancy, including possible birth defects, due in 2025.
- Various studies to assess myocarditis and pericarditis after administration of vaccine, due between 2022 and 2026.
- A study to assess the safety and effectiveness of the vaccine in children 12-15 years of age (spring 2023), 6 months to <12 years of age (fall 2023), and children <6 months of age (summer 2024).
The approval letter also specifies deadlines for submission of final content of labeling “as soon as possible, but no later than 14 days from the date of this letter,” and proposed advertising and promotional labeling “before initial dissemination.”
The second letter, addressed to Ms. Elisa Harkins of Pfizer Inc. in Pennsylvania, is a revision of the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine. While this letter acknowledges Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY are biologically equivalent and can be used interchangeably, it creates a legal distinction between them. This letter authorizes the continued use of Pfizer-BioNTech COVID-19 Vaccine and, when it is available, COMIRNATY in children between 12 and 15 years of age. It also authorizes administration of either vaccine in a third dose (“booster”) to certain immunocompromised individuals. It further permits Pfizer to continue to provide Pfizer-BioNTech COVID-19 Vaccine (but not COMIRNATY) to individuals 16 years and older under emergency use authorization until Pfizer’s inventory is consumed. All product labeled Pfizer-BioNTech COVID-19 Vaccine will “clearly and conspicuously state that it has not been approved or licensed by FDA.” Even though the vaccines are the same, if you get one labeled “Pfizer-BioNTech COVID-19 Vaccine”, you are not getting an approved vaccine; if you get the one labeled “COMIRNATY”, you may be, as long as you’re at least 16 years old and getting your first or second shot.
Yesterday I said that if the FDA short-circuited its rigorous approval process, the results would be deadly. I am not accusing the FDA of doing so; I am not an expert in FDA procedures. But I think we can agree that this approval is complicated, that some information we would all like to see is missing, and that much of that missing information won’t be available any time soon.
- Quick Chart on Current Covid Vaccines
The vaccine landscape became more complicated this week after FDA’s approval of COMIRNATY, the vaccine manufactured by Pfizer Inc. of New York for BioNTech Manufacturing of Mainz, Germany. I’ve prepared this chart to aid understanding of what’s approved, what’s authorized by EUA, and what’s neither approved nor authorized. I’ve also included the major warnings listed on the factsheets or prescribing information for each vaccine. A “No” in this section doesn’t necessarily mean that the complication cannot happen, since all authorized vaccines include the warning of other risks that are not listed.
An FDA approved vaccine is not available for injection as of this writing. We are learning that all these vaccines are “leaky.” Soon, I’ll post an article that breaks down what a leaky vaccine is and what that means for the pandemic.
- RSV
Respiratory Syncytial Virus (RSV) is a highly infectious virus that can lead to serious disease in children. The virus emerges each year roughly at the time school starts in the fall and subsides later in the spring. Midsummer RSV is unusual. Last year we did not see the typical rise in RSV, but this year the RSV surge started much earlier and is of much greater magnitude than normal. Our COVD-19 response has unintentionally increased children’s risk from RSV infection.
Respiratory syncytial virus, named because of the unique appearance of infected cells under the microscope. Lock downs, social distancing, and masking, whether voluntary or mandated, changed the rhythm of upper respiratory infections like RSV and Flu. Flu has yet to return; the last infection diagnosed in my practice was in May, 2020, at the tail of the 2019-2020 season. But RSV has returned with a vengeance, all over the world. To illustrate, look at this graph of RSV infections in Tokyo for the years 2017-2021. And this year’s cases are more severe than before. According to CDC, “Due to the reduced circulation of RSV during the winter months of 2020–2021, older infants and toddlers might now be at increased risk of severe RSV-associated illness since they have likely not had typical levels of exposure to RSV during the past 15 months.” You read that right. Anti-COVID measures, regardless how well-intentioned or how necessary, will cause more severe RSV disease in our children this year.
Just how severe is RSV? RSV is a major viral cause of death in children 5 years of age and younger, with mortality rates estimated between 0.5 and 1.7% in healthy U.S. children, but devastatingly higher in immunosuppressed children and in the children of the developing world. By comparison, the mortality risk for infants and children infected by SARS-CoV-2 is under 0.03%. RSV is a more serious risk to our kids than COVID.
There is no vaccine for RSV, and there is no treatment other than supportive care. Severe cases require ventilator support in a pediatric ICU. Most patients survive. According to the American Academy of Pediatrics Red Book, most kids are exposed to RSV by the age of 2, and reinfection is common.
Which brings us to the point. Even though RSV can cause a serious and deadly viral respiratory illness, the virus circulates among children. Children live with this virus. RSV prevention measures are targeted toward those at highest risk of death from the virus. Eradication of RSV is not the objective, and, as our experience in 2020 and 2021 suggests, may not even be desirable. The disruption of the seasonal viral pattern by implementation of COVID-19 precautions has increased the risk of sickness and death by RSV this year. Children derive benefits from natural exposure to RSV that may be important to their future survival.
We need to be aware that our actions during this pandemic can have consequences beyond what is in view. Homelessness, suicide, drug overdose, and now increased RSV–all unintended consequences of our public health policies. With this in mind, and the possibility of other unknown variables, we need to target our prevention efforts toward those at greatest danger. We must agree on a clear, sensible, and attainable objective. We must learn to live with the virus.
- Leaky Vaccines
A perfect vaccine protects like a child’s immunity after chicken pox. It prevents future disease, prevents transmissions to others, and lasts for a very long time. Anything less is called a leaky vaccine. Let’s see how our current COVID vaccines stand up to each of these points:
- Prevent Future Disease. COVID vaccines don’t connect on this standard, and there are any number of reports that can show this. Just to pick one we haven’t discussed before, read the MMWR Early Release for August 24, 2021 which shows vaccine effectiveness dropped from 91% to 66% since the arrival of the delta variant, suggesting that vaccine is less protective against delta than pre-delta strains. But this data also shows that vaccine protection from disease was less than perfect even before delta. A perfect vaccine has effectiveness of 100%; our COVID vaccines never have.
- Prevent Transmission of Virus to Others. Another swing and a miss. To drive this point home, we need go no further than the CDC’s Recommendations for Fully Vaccinated Individuals, which states, “Preliminary evidence suggests that fully vaccinated people who do become infected with the Delta variant can be infectious and can spread the virus to others.” Still not convinced? A recent pre-print study from Vietnam demonstrates transmission between vaccinated healthcare workers. A perfect vaccine would prevent infection between vaccinated individuals; our COVID vaccines do not.
- Lasts for a Long Time. Strike three. Even though the vaccines have been available for less than a year, emerging data from Israel suggests that their effectiveness is already waning. My own antibodies lasted for less than five months. Vaccine-induced immunity doesn’t last very long.
Our COVID vaccines are leaky. So what? Just take a booster. And another. And another.
There are several problems with this reasoning. Here are three:
First, a false perception of protection leads to risky behavior. Maybe you’re young, and it doesn’t matter if you get a SARS-CoV-2 infection. Maybe you’re pregnant or elderly, and it does. When you believe that your vaccination protects you from future infection, you are more likely to ignore precautions that might protect your life, or the lives of others.
Second, leaky vaccines may stimulate the formation of more dangerous variants. The theory goes like this. The virus seeks a host. If vaccination reduces but doesn’t eliminate the available hosts, the virus feels evolutionary pressure to mutate into a form that will infect more people. Not everyone agrees with this idea, but there is enough evidence to at least consider this possibility.
Finally, leaky vaccines will not eradicate SARS-CoV-2, no matter how many boosters you take. Vaccination has eradicated exactly one human viral pathogen from the earth: smallpox. The smallpox vaccine was a perfect example of a perfect vaccine. It prevented disease. It prevented transmission. It lasted a lifetime. It eradicated the virus from the earth. And it took nearly 200 years. We cannot expect a leaky vaccine to produce the same results.
Maybe future vaccines won’t be as leaky as the ones we have now. Maybe we’ll even have a perfect COVID vaccine someday. We can hope. But until then, eradication is a pipedream. Instead, we must do all we can to protect the lives, the health, and the wellbeing of people while the virus is among us. We must learn to live with the virus.
- Quick Chart on Covid Mortality
This chart on Covid mortality provides perspective during the current spread of the delta variant. The CDC COVID Data Tracker shows weekly rates per 100,000 population for COVID-19 cases (CDC’s term for infections) and deaths since the outbreak of the pandemic. Selecting the dates corresponding to the peak death rate for each viral surge in the United States, I divided deaths by cases to approximate risk by age group:
While neither a comprehensive statistical analysis nor an entirely accurate calculation, this chart gives an idea of relative risk at important points in the pandemic. The delta wave has not peaked, so we may have not seen the highest death rates from the present surge. The risk of death for the elderly is consistently higher than for younger individuals, and, with few exceptions, age adjusted death rates have decreased in successive waves of the virus. Maximizing survival should be our objective as the pandemic continues.
- How We Got Here
It was a scary time. When the first wave of COVID-19 swept through the nation in the spring of 2020, infection rates, hospitalization rates, and death rates climbed rapidly, and we didn’t know how high they would go. Nursing homes were especially ravaged. Once infected, more than 40% of people over 75 years old died. We were focused on keeping people alive, and we were committed to making sure that the sick had the resources for their best chance at survival. As hospitals filled up, our greatest fear was that people would die waiting for a ventilator. We determined to decrease the height of the wave by stretching out the time it would take to pass over us. Whether you agreed with the policy then, whether you agree with it now, that’s why we locked down, masked, and social distanced. We thought it was the best way to accomplish our objective of keeping people alive.
As the first wave passed, we relaxed a bit and found ways to feel normal again. We all stocked up on toilet paper. We tested small gatherings on Memorial Day and Independence Day. Those of us who survived (regrettably not all of us did) became convinced we could survive again. As the second wave of COVID-19 swept over us in the summer, we had new tools—tests, convalescent plasma, and drugs. And we had the promise of vaccines. If we could just hold on until the vaccines arrived, we would have a lifeboat that would save us from the virus and make things normal again. We all wished it would be so; it was not to be.
The second wave was devastating, infecting more people, and lasting longer than the first. Again, the elderly, the obese, and the diabetics were hardest hit, but more people survived infection this time. Mortality rates for those over 75 years old were cut in half—still too high, but better than before.
As the second wave passed and we entered the calm of fall, we began to see our vaccine saviors on the horizon. Applications were submitted to the FDA. But by now, the virus had mutated, and the more infectious alpha variant headed our way. This third wave, the largest and broadest of the three, proved that we had learned how to handle the virus. Death rates for infected individuals older than 75 dropped to 15%, about the same as Russian roulette. Still, more Americans died in the third wave than in the previous two combined.
As the alpha wave headed towards its crest, Pfizer-BioNTech received an EUA for its vaccine. People clambered for vaccination, especially the elderly and front-line health care workers. Moderna was authorized, then Janssen. Local health departments organized waiting lists, and people skipped work when they got the call for their turn. Operation Warp Speed put vaccines into arms in record time. And the alpha wave began to subside. There seemed to be an inverse correlation between vaccination rates and infection rates.
It was about this time, as lifeboats appeared on the horizon, that we lost our way. We stopped focusing on helping people survive, and we put our energy into pulling people into the lifeboats. We didn’t recognize that the boats were leaky, and that some people were better off where they were. We believed that vaccination would lead to eradication which would lead to freedom and our pre-pandemic lives again, but it wasn’t true. Even as the alpha wave receded, it became clear that the virus would be here to stay.
Yet we clung to the fantasy. We abandoned our initial objective of helping people live. Instead, we believed in the make-believe of universal vaccination—if we could just vaccinate everybody, the virus would leave earth. Nevermind that the vaccinated can pass the virus to others; at least they won’t be infectious for as long. Nevermind that the vaccinated get sick; at least they won’t die. Nevermind that some vaccinated died; their deaths are clearly the fault of the unvaccinated. Nevermind that vaccination doesn’t last very long, doesn’t prevent severe disease, and isn’t as good as natural immunity. Vaccinate! Vaccinate! And vaccinate again, with unauthorized boosters! Afterall, it’s a pandemic of the unvaccinated.
As the delta wave washes over us now, we must have the courage to believe what we see. Our vaccines are leaky, and they will not eradicate the virus. We cannot vaccinate our way back to our pre-pandemic lives. It’s time to change the paradigm.
We must return to our original objective of keeping people alive, and we must measure our actions, our public health policies, and our pandemic response against this objective. When we stop following the fairytale of universal vaccination, we can use vaccination as a tool to further our true objective of survival. We must develop other tools, prophylactics, and early treatments, and we must see whether any old tools can be repurposed to accomplish our objective.
We can defeat this pandemic if we change course, but the window of opportunity is closing. We must change course now.
- O Goodness
The pandemic is a war, and our objective is survival. Many have asked what they can do to help the war effort. One way is to donate. I’m not asking for your money. I’m asking for your blood.
A chronic blood shortage has existed throughout the pandemic, but blood becomes even scarcer during surges. There are several reasons for this. People are reluctant to leave home. Work from home and distance learning reduces the yield of blood drives at businesses and universities. The health and safety measures necessitated by the pandemic reduce the rate at which donors who can be processed. All these factors result in less blood available for patients who need it.
Red blood cells are important because they carry the oxygen which fuels the body. Concentrations of red blood cells are given to patients who need a boost in their oxygen carrying capacity; sometimes this boost is lifesaving.
But it’s not as simple as taking blood from one person and giving it to another. Among other things, blood must be tested for compatibility. Every individual has a blood type, which corresponds to antigens on their red cells. Think of antigens as little self-destruct buttons on the cell surface. These buttons are imaginatively named A and B. There are four possible configurations of antigens, and these correspond to a person’s blood type. If you have only A antigens on your red cells, you are blood type A. If you have only B antigens only, you are blood type B. If you have both A and B antigens, you are blood type AB. And if you have no antigens, you are blood type O.
The buttons are pressed by antibodies floating in the liquid part of your blood. When the buttons are pressed, the red cells self-destructs (“hemolysis”). Don’t worry; your body can’t trigger the buttons on red cells made by your body. But your antibodies can trigger the destruction of red cells received during a transfusion. When transfused red cells self-destruct all at once, you have a reaction, and you could die. That’s why we want to know your blood type before transfusion. We need to make sure that the blood you get is compatible with you.
It turns out that if you are blood type A, you have B antibodies, meaning you can’t have any blood cells with B buttons. If you are blood type B, you have A antibodies, meaning you can’t have any blood cells with A buttons. If you are blood type AB, you don’t have any antibodies; you can get anybody’s blood (lucky you!). If you are blood type O, you have both A and B antibodies, so you can only get type O blood. But the cool thing about type O people is that there are no self-destruct buttons on their red cells. That’s why we call blood type O individuals “universal donors”—they can give their blood to anyone. In the blood bank world, O is good.
Type O blood is especially important in emergencies since there may not be time to test blood type before transfusion. At those times, type O blood is given immediately. O blood saves lives.
Our blood supply depends on the goodness of people. Since donation is the only source of blood, there’s just one reason blood is available for patients who need. It’s because someone took the time to give their blood voluntarily. About 45% of Americans are blood type O. If that’s you, you’re special. If that’s not you, we need your blood too. Having a supply of all blood types preserves type O blood for emergencies and for patients who can have no other type.
It may take a little extra time to donate during the pandemic, but your donation is needed now more than ever. It costs nothing but your time. It doesn’t matter if you’ve had COVID-19, been vaccinated, or not. Please consider making an appointment at a donation center now.
If you live in the Dallas-Fort Worth area, make an appointment here. Otherwise, find a blood center in your area here.
- Is It Science?
How do you carve a statue of an elephant? Start with a block of stone and chip away everything that is not elephant. Science is like that. The elephant is truth; science is the chipping away. Scientists are the carvers, chiseling different parts of the stone block at once, testing and repeating each other’s findings, remodeling as new evidence emerges, and accepting the image that finally appears. Science is more verb than noun. It’s not the science; it’s just science.
You can’t predict what science will reveal hidden in the stone block. Even after the block is partially carved, you can’t be certain about important details that are still hidden from view. Science doesn’t reveal truth until scientists have finished their work, and that work cannot be rushed.
True science is open source. It invites questions, dissent, and transparency. True science is not condescending. True science can be understood by people with common intelligence. More than anything, true science is honest. When you identify misstatements, half-truths, or “believe me because I know better than you,” it doesn’t necessarily mean someone is trying to rob you, but it does necessarily mean you are not dealing with science.
And this is the point. Today’s intemperate rhetoric claiming to be science isn’t science at all.
I don’t have all the answers, but I recognize the absence of science in statements of leaders who say, “This is a pandemic of the unvaccinated.” The wisdom of universal vaccination, the benefits of vaccine mandates, the rejection of natural immunity have not been established scientifically. The use of ivermectin and hydroxychloroquine as prophylactics and early treatments have not been disproven scientifically. Yet there is an unrestrained rush to incorporate these ideas into the dogma of previously unimpeachable institutions and into our public health policies. It makes me sad. It makes me fearful for our future.
- When We Lose Trust
There is a crisis of trust in America. One manifestation is in healthcare. For a century, the trust among Americans, their physicians, and institutions of public health built the most reliable healthcare system in history. Today that trust is being undermined, and the entire system is in danger of collapse. If we do not restore trust, we will suffer the reversal of a century’s gains in medicine.
The Youngest Science, a collection of essays by Dr. Lewis Thomas, traces medicine’s journey from pre-twentieth century practices into the evidence-based practices of today. Before this transformation, medicine was an unreliable mixture of traditional treatments like blood-letting and fanciful concoctions like snake oil tonic. Transparency, empirical evidence, and patient collaboration were absent.
Although there were many well intentioned physicians before the twentieth century, greedy hucksters and evil-doers thrived in this environment. Quacks with phony credentials wagoned into town hawking the one-and-only genuine medicinal potion that promised to cure whatever ailed you, often accompanied by craftily staged demonstrations. After selling as many worthless “cures” as possible, these predators escaped at night, leaving townsfolk poorer but in no better health. People naturally feared being duped again. Medicine could not progress in this environment.
In the twentieth century, trust changed all this. Beginning in 1906 with the Pure Food and Drug Act, the federal government developed institutions like the FDA, CDC and NIH to assure the safety and effectiveness of drugs and treatments. State governments licensed physicians and established standards of medical practice. Physicians organized, creating boards to prevent frauds from entering their ranks and abusing the trust of their profession. By the end of the last century, healthcare providers were among the most trusted professions in the nation. So much so that people were willing share intimate personal details with a stranger, as long as that stranger was a doctor or a nurse.
Now we see an erosion in the trust at the foundation of the youngest science. When trusted institutions like the CDC and FDA give incomplete or misleading statements, physicians lose a resource for reliable information. This quickly translates to a loss of the trust that bonds patients and physicians. As employers and political leaders displace physicians by claiming to be health experts, people are unsure who to believe. We’re back in the nineteenth century again.
It didn’t have to be this way. We could have leveraged medicine’s abundance of trust to lead us to recovery. Our trusted institutions could have given physicians the tools needed to make meaningful risk-benefit calculations for patients. But this would have required the acknowledgement that natural immunity is at least as good as vaccination in some COVID survivors, that vaccination is harmful to some individuals, and that vaccination does not prevent the spread of disease. We could have determined which groups receive the greatest benefit from vaccination, and which groups are most likely to suffer adverse effects. We could have guidance on measurable markers of immunity—what are the minimum protective antibody concentrations, and what levels are toxic—so that those at greatest risk of death from COVID-19 can determine whether they will benefit from vaccination or booster. We could have real data on adverse effects of vaccines by age and health status, and we could have balancing data on risk of death by SARS-CoV-2 infections. We are 18 months into the pandemic; we should have this information by now. Instead, our public health institutions have adopted an incredulously monolithic policy, saying universal vaccination is our only way out, even though we know this policy violates the oath of my profession: Do no harm.
Our trusted health institutions, like our trusted political institutions, have failed to communicate a clear, achievable objective for the pandemic. They have failed to demonstrate a connection between their policies and the achievement of this goal. As a result, we’ve lost trust. This crisis of trust has created a crisis of healthcare.
We must restore trust, together. The health of our nation is at stake.
- COVID Serology
The immune system is a big complex machine. Medicine tries to simplify the machine to make it understandable and to manipulate it to our advantage. That’s why we measure antibody levels in the blood. The measurement of antibody levels in the blood is called serology. Serology doesn’t measure the whole immune system, but we do it because it’s easy, and it gives us an idea of what’s going on.
Your immune system is stimulated by molecular structures that are not native to you. You could say that your immune system is xenophobic, reacting against foreigners. And your immune system has a long memory. Once stimulated, these memories allow your immune system to mount a defense quickly should that foreigner ever be encountered again. For many infectious agents, including SARS-CoV-2, this means the formation of antibodies which can be measured in your blood.
When you are infected by the virus, your immune system is exposed to all the molecules that make up that virus. Your immune system can respond to any of those molecules, including one special molecule: the spike protein. We need to understand what makes spike protein so special.
Contact between the spike protein on the SARS-CoV-2 virus and a cell inside the nose is the first step in the infection of our bodies by these tiny invaders. The spike protein is like a key that unlocks the vault, giving the virus access the interior of the cell. Once inside, the virus hijacks the cell machinery, converting it into a virus manufacturing plant. Thousands of copies of the virus are pumped out which infect neighboring cells, and the process repeats.
Antibodies to spike protein are special because they are neutralizing antibodies. Neutralizing antibodies get between the viral key and the cellular portals, acting like putty gumming up the keyholes. That’s why code for spike protein is the active ingredient in mRNA vaccines, and that’s why we should be able to measure vaccine response with spike protein antibodies. Other parts of the immune system are activated too, but these work after the virus has entered the body. At least that’s the theory.
How well does all this work? Imperfectly.
While vaccination may reduce the risk of future infection, it does not prevent it. Breakthrough infections occur. Maybe that’s because neutralization only happens when antibody levels are high enough. Or maybe neutralizing antibody levels fade within months of vaccination. Or maybe the small alterations in spike proteins of variants make vaccine-induced neutralizing antibodies less effective. Or maybe it’s a combination of all these ideas. We really don’t know.
And there’s the point. We really don’t know. We certainly don’t know enough to make universal vaccination the sole objective of our pandemic response. Vaccination is a tool that can be used to keep people alive, but it should not become the primary goal. Other theories need to be investigated to identify our best hope for survival.
For example, here’s a theory that should be investigated. Based on what we know about the immune response, natural immunity from COVID-19 should be more durable, more protective, and better for our communities than vaccine. Why? Natural immunity exposes the immune system to many different molecules, not just spike protein, making it more likely to sustain emergence of new variants. More durable immunity generates longer lasting herd immunity, reducing the size of subsequent disease spikes. At least that’s the theory.
How well does it work? We don’t really know.
Although other nations have found wisdom in this theory, the CDC has not permitted us to try it. Instead, the CDC stubbornly holds on to the universal vaccination idea, even vaccinating COVID survivors regardless of their antibody levels.
So how do we get out of this? We need data. We need answers to questions like what antibody levels indicate protective immunity? How long does natural immunity last? Is vaccine-induced immunity as protective natural immunity against variants? Can antibody levels be too high? What are the optimal antibody levels?
That’s why I’m excited about the Texas CARES Survey. This study sponsored by the UT Health Science Center at Houston, with testing by my friends and colleagues at Clinical Pathology Laboratories (CPL), promises to give us large cohort retrospective data on durability and magnitude of antibody responses after disease and/or vaccination, with matching outcomes. Although the study has met its initial enrollment goals, check back for results and more opportunities to participate.
Why has it taken so long to ask these questions?
- Long COVID
COVID-19, the disease of the pandemic, has two pathways. In one pathway, viral infection directly causes the upper respiratory symptoms like runny nose, cough, fever, sore throat, and, in severe cases, pneumonia and respiratory failure. The second pathways is associated with some of the more confounding symptoms of COVID-19 like loss of taste and smell, myocarditis, pericarditis, cardiac arrhythmias, migraines, cognitive deficits, Guillain–Barré syndrome, Bell’s Palsy, and blood clots. These symptoms sometimes appear with infection, but often they emerge after the acute illness is over, and they may last a long time. This is what is known as “Long COVID.”
Long COVID doesn’t happen to everyone infected by the virus. It seems to affect women more than men, and the middle-aged more than the very young or the very old. But for those affected, long COVID can be painful and debilitating.
There are several ideas about what causes Long COVID. One plausible idea is that the immune response mounted to fight SARS-CoV-2 attacks the body’s own cells. In other words, Long COVID may be an autoimmune disease. Viewing this phase of COVID-19 as an autoimmune disease forms the basis for the use of drugs known to tamp down the immune response as an early treatment or preventative for COVID-19. These drugs may also help patients who are struggling with long COVID symptoms.
It’s intriguing that many vaccine complications overlap with long COVID symptoms. Vaccine fact sheets contain warnings for myocarditis/pericarditis, blood clots, and Guillain-Barré Syndrome. These are all immune-mediate processes—in other words, autoimmune disease from an immune system primed to attack your own body. Vaccination is designed to mount an immune response to the spike protein, the tool the virus uses to pick the lock on the door to your body. If Long COVID is an autoimmune response, it’s not surprising that vaccination may cause a similar response.
Another intriguing observation made by me and some of my colleagues, but one I’ve not found published, has to do with the timing of adverse effects of vaccination. I want to be clear that adverse effects of vaccination seem to be rare. Yet, complications occur. The observation is that people who’ve had COVID-19 before taking a vaccine seem to have adverse effects of vaccine immediately if they have them at all. Alternatively, people who have never had COVID-19 have adverse effects of vaccine weeks after vaccination if they have them at all. It makes sense that people who’ve had COVID-19 have an immune system primed for an immediate response, while those that have never been infected need time before the effects are seen.
These observations bring up a couple of questions. Can vaccination cause an autoimmune disease like Long COVID? And if so, will treatments for Long COVID be helpful to those people?
There’s still so much we don’t know.
- Deception
Misconceptions about COVID Vaccines are fueling vaccine mandates. The CDC has contributed to these misconceptions by its recent statements and actions. Trusted institutions and processes are now corrupted by a political agenda that has licensed vaccine mandates. Next will be vaccine passports and social credit scores, resulting in the loss of human rights.
Last week, FDA published a new combined Vaccine Information Fact Sheet for Recipients and Caregivers About COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus disease 2019 (COVID-19). This Fact Sheet explains the distinction between Pfizer-BioNTech COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA). This document states that the two vaccines “can be used interchangeably,” but are “legally distinct” (see footnote 1). COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-licensed vaccine for individuals 16 years old and older; Pfizer-BioNTech COVID-19 Vaccine is an authorized vaccine for individuals 12 years and older. COMIRNATY inherits Pfizer-BioNTech’s EUAs; Pfizer-BioNTech is not grandfathered into CORMINATY’s license.
The new Fact Sheet also expands emergency use authorization for third shots (boosters) of both vaccines. In doing so, the FDA followed the spirit, if not the letter, of its independent Advisory Committee Meeting on Vaccines and Related Biological Products Advisory Committee September 17, 2021 (watch following 7:42:00).
On the other hand, the CDC’s information and guidance has been confusing and misleading. On its website, the CDC ignores the legal distinction between the two vaccines so carefully parsed by the FDA, inaccurately lumping them under the label “Pfizer-BioNTech (COMIRNATY) COVID-19 Vaccine” and saying that the FDA approved this vaccine on August 23. That’s not exactly true. But the misinformation has taken root. Even factcheckers are spreading the false claim that Pfizer-BioNTech and COMIRNATY vaccines are legally equivalent.
Last week the CDC went further, recommending boosters for individuals not included in the FDA’s Emergency Use Authorization in contradiction to the CDC’s own Advisory Committee on Immunization Practices. Dr. Rochelle Walensky, director of CDC, justified this action (watch following 27:57) by saying it was a “scientific close call,” (28:22) and that she would have voted in favor of the recommendations if she were part of the committee (28:36). But she wasn’t part of the committee, and it wasn’t a close call.
Close calls are judgments made on the sports field, risk calculations during a game of chess, or complicated ethical determinations. Close calls are decisions made with incomplete information, under the stress of time, that exceed our computation ability. None of this describes science. Science is a method that either disproves an idea or does not. There are no “scientific close calls.”
The CDC overstepped its jurisdiction. The FDA, not the CDC, issues emergency use authorizations. Yet now CDC guidance is at odds with FDA’s EUA, bypassing the safety afforded by this carefully thought-out process.
There was a reluctance to embrace vaccine mandates until FDA licensed a vaccine. On August 23, the FDA licensed a vaccine which is still not available. Instead of giving us a licensed vaccine, the FDA gave us a license to mandate vaccines. In August, the White House promised booster shots by September 20. Last week boosters were made available under CDC guidance via a short-circuited process. This is not science. This is politics.
These are smart people who have studied logic and rhetoric at the finest colleges and universities in the land. They should know better. They do know better. This is deliberate and bold deception. Trusted instructions of science and medicine have been corrupted to further a political agenda. Now that we’re out of the realm of science and in the world of politics, speculation runs wild. My speculation is that someone wants to sell vaccines, and lots of them. My speculation is that vaccine mandates will lead to vaccine passports and social credit scores which will eliminate our human rights. No wonder there’s a crisis of trust in America.
- A Physician’s Descent into the Abyss
Next to my wife and family, medicine is my life. I go to work in a hospital almost every day, and while I’m there, I’m focused on the patients whose blood, fluids or tissues come to my attention. I give them the very best I can, not perfectly, but humanly. Many patients aren’t aware that pathologists exist, but if you’ve ever been on a Hero’s Journey involving cancer, you know who I am. I was there at your jumping off point. I’m the one who signed your biopsy report, giving you the information needed to face the monsters of your quest. I’ve never personally experienced cancer, although both my wife and I have fathers who did, but I see cancer up close daily, and I frequently encounter those on the cancer journey.
Here’s a short summary of the Hero’s Journey. A hero candidate is called out of ordinary, mundane life to go on a quest. The candidate initially resists but is eventually drawn to the edge of the abyss and outfitted for the journey. Descending into the darkness, the hero enters a fantastic, dream-like world where rules of ordinary life don’t apply. Think Star Wars, Alice in Wonderland, or Odysseus in Hades. Real dangers are encountered, and sadly, not all heroes survive. But those that do come back to the ordinary world changed, and they share their wisdom with the generations. Joseph Campbell’s masterful articulations of the Hero’s Journey demonstrate that this formula transcends cultures and epochs. Cancer survivors know what I’m talking about because they’ve been on a Hero’s Journey.
Although I don’t feel much like a hero, COVID has sent me tumbling out of my ordinary world into an abyss. My pre-pandemic world was based on trust. Physicians are taught to think for themselves, but to doubt themselves at the same time. More than anything else, our education and training teach us that we just don’t know enough. There’s always someone smarter or intellectually more energetic, someone who dives deeper or stretches broader than we can ever hope to do. Yet there’s something about this humiliating self-awareness that gives us the tools we need to help those in the ordinary world with their ordinary health problems. We frequently consult trusted references, colleagues, and experts, and as we do, it slowly begins to make sense. Experience gives us confidence, and that confidence is transferred to our patients. Physicians become the handles patients hold onto when the earth drops beneath their lives.
The pandemic has changed all that. Physicians feel compelled to take sides. You either stand with most of your colleagues and friends, medical associations, and trusted institutions like the FDA and CDC, or you stand with what has made sense to you throughout your career. The pandemic has made this an either-or proposition. Like 1984, it’s a battle between your thoughts and the thought police; you either participate in the Two Minutes Hate enthusiastically, or you risk vaporization.
My trust in the CDC began to wane in May when, in contradiction to my education and training, the agency insisted on vaccination of COVID survivors. My trust was further depleted when I realized testing would not be used to guide vaccination decisions despite years of established pre-pandemic practice. Now, there is contradictory information published on CDC and FDA websites, and disregard for approval and authorization processes. Yet even the act of pointing out these discrepancies separates you from the herd like a calf in a cutting horse competition.
I have decided to stand for truth with the confidence instilled by my education, training, and experience, no matter what. There’s a lot in that “no matter what”—isolation, ridicule, coercion. But if you don’t have your thoughts, you don’t have your humanity. Humans are not required to believe alike, but they are required to believe. I am determined to crawl out of the abyss, humanity intact, back into the ordinary world, dragging as much trust with me as I can carry.
Maybe some of my colleagues will identify with what I’m saying.
- Winning the War Against Therapeutic Nihilism
Dr. Peter McCullough spoke to the Association of American Physicians and Surgeons at their annual meeting on Saturday, October 2. He gives a clear, easy to follow, scholarly perspective on the causes and treatments of COVID-19 and the safety and efficacy of COVID vaccines. It’s a little more than an hour long, but I recommend you stop reading this blog and watch it by clicking here. If you don’t have an hour to watch the video right now, here are my CliffsNotes version of Dr. McCullough’s talk, complete with video references.
There are serious safety concerns with COVID vaccines. Lapses in usual safety standards plagued vaccine development and distribution (8:10). Groups excluded from pre-authorization clinical trials are receiving vaccine (9:13), including pregnant women, women of childbearing age, COVID survivors, people with suspected COVID, and those with positive COVID serologies.
The CDC and FDA have misled the public about vaccine safety. They minimized vaccine related deaths (14:14), and they have not provided periodic safety reports. Despite what is reported in the media, the FDA did not approve Pfizer-BioNTech COVID-19 Vaccine (22:10). The CDC manipulated data to support the “Pandemic of the Unvaccinated” narrative (29:15). Of Americans hospitalized patients with COVID during the delta wave, 23% have been vaccinated (32:20). The CDC and FDA have failed to emphasize that seniors suffer the most vaccine failures (30:20). Instead, they are focused on authorizing vaccines for children, a group that has a greater risk of hospitalization for vaccine-induced myocarditis than for COVID-19 (18:16). The CDC and FDA cannot be trusted to provide honest information about vaccines.
The universal vaccination policy must change. All vaccines have failed against the delta variant (26:45), and they have not stopped the spread of virus (23:57). Vaccines are forcing viral mutations (34:05); as vaccination rates increase, natural viral diversity decreases. Vaccines produce narrow, limited immunity (36:00), and vaccinating COVID survivors causes harm (49:19). Vaccinated individuals are as likely to spread virus as unvaccinated individuals (37:07). On the other hand, natural immunity is robust, complete, and durable (49:09). Natural immunity is the only backstop to virus spread (50:00).
Treatments, not vaccines, drive down COVID mortality (33:43). COVID-19 is a complex disease, but early home therapy is effective (38:30). Inadequate treatment is responsible for COVID-19 deaths (44:34). Many seniors have been abandoned by their doctors (45:47), but A Guide to Home Treatment of COVID-19, made available free by the AAPS, fills gaps in management (46:39).
People are losing human rights. Basic freedoms are now dependent on vaccine status (50:24). We need outrage over ineffective and unsafe vaccines (52:45), we need doctors to be doctors (54:35), and we need journalists who recognize that something is wrong (56:36), that there has been a suppression of treatment resulting in fear, suffering, loneliness, isolation, hospitalization, and death (56:50).
But my notes do not have the eloquence and power of Dr. McCullough’s own words. Please, click here and listen to five minutes, then stop when you want. If you can.
- Stop Calling It Science
Medicine is my professional life. Science is the language of medicine, or at least it used to be. I’m not a scientist; I’m a practitioner. But I love science, just like I love ideas. Ideas separate humans from other living organisms, and ideas are often played out in the arena of politics. I am not opposed to politics, but I am opposed to deception. It is deceptive to hide behind the label of science to cover political actions.
I don’t believe today’s misuse of science is accidental. Those doing it are too smart and too well educated to make that mistake. Phrases like “follow the science” and “scientific close call” give an air of legitimacy to policies that are driven by agenda rather than facts and knowledge. Counter examples are ignored; theories are not allowed to be disproven.
Today’s orthodoxy is defined by elite high priests who possess secret gnostic knowledge. Scripture is what the priests say it is. Ordinary people have no access their secret data. Opponents of orthodoxy are labeled heretics, and some are vilified as examples to those tempted to stray. There are rites that involve the letting of blood, and these rituals must be repeated periodically to maintain continued salvation. Mass demonstrations of faith by believers prove their devotion to a movement that promises a second coming of pre-pandemic life sometime in the distant future, even though exactly when and how that will happen is vague. Occasionally, human sacrifice is required to appease the gods, but those chosen for sacrifice must not complain. The lambs must accept their fates willingly. There can be no dissent. Heterodoxy is not permitted in a nation whose motto is “In Science We Trust.”
This is not science; this is religion. Despite the first amendment to our constitution, our country is being turned into a theocracy, worshiping at the altar of “scientism.” Scientism is being used as a tool to advance a political agenda, not a scientific one.
Science is a process that establishes our best understanding of truth by disproving all that is false. Someone says, “I have an idea,” and other scientists set out to prove it false by experiment. “If your idea is true,” the experimenters say, “then my experiment should work out this way; since it worked out that way instead, your idea must be false.” Experiments never prove an idea true. “Scientific truth” is a probability not a certainty. It’s subject to revision when someone invents a better idea, shifting our understanding into a new paradigm.
Skepticism is integral to the scientific process. When doubt is not allowed, it may be many things, but it’s not science.
- Belief and Knowledge
I am not a scientist, but I love science. I am not a theologian, but I love theology and the effects of spirituality on my life. Just like I am a practitioner of pathology, I am also a practitioner of faith. I am enriched by both.
Religion deals with matters of belief. Science deals with matters of knowledge. Both address the big questions of life—”Why are we here?” “Where are we going?”—but from different perspectives. One is not a backstop to the other. Beliefs are not morally inferior to knowledge, just as knowledge is not morally inferior to beliefs. Both are important, but they live in different realms. Innocently confusing science and religion leads to superstition, ignorance, or harmful conclusions. Deliberately confusing science and religion is a deception that robs us of material and spiritual treasures.
Falsification is a key distinction between belief and knowledge. A scientific claim is falsifiable, meaning it must make a prediction that can be tested by experiment. If experimental results are not what the claim predicts, then the claim is false. But if experimentation supports the claim, it’s not necessarily true; it simply might be true. The scientific process is a last man standing game. The longer a claim stands, the more likely it is to be true. At some point, when an idea becomes more likely than anything else, we call it knowledge. But knowledge is, and always has been, what is most likely true, not what is certainly true. We can only have scientific certainty about what is false.
Lack of certainty isn’t the only limitation of knowledge. There are scientific horizons, and we cannot see what’s on the other side. For example, the universe is most likely expanding, but expanding into what? We cannot know. If the universe is expanding, then it must have been smaller before, and even smaller before that, and so on until it’s a tiny universe holding all matter and energy. But what happened before that? We cannot know. What’s outside the event horizon of light, or the gravitational horizon of black holes? Does our physics work there? Can alternate universes coexist? We can hold beliefs about these things, but these questions are not in the realm of science. We have no applicable knowledge because we have no power to observe.
Science has significant limitations. We can never be certain about what science tells us, and there are some questions that are not open for scientific investigation. Religion also has limitations, but different ones. Religious claims do not have the requirement of falsification. Omnipotence is the ultimate answer for all religious questions. When there’s no experiment that can demonstrate an idea to be false, it cannot be science, but it can be religion. Science requires falsification; religion requires faith. Faith and beliefs are good things. They give us hope, purpose, and compassion. Science cannot.
Despite its limitations, science is a powerful tool that augments our understanding of reality. We cannot rely on science to give us quick answers, so during this pandemic, we must have faith—lots of faith. But we also must speed science along by testing as many ideas as possible, all at the same time. A pandemic response that clings to ideas which are demonstrably false and dismisses competing ideas without experiment is not based on science. It’s religion pretending to be science, and it’s dangerous. There are three explanations for nonsense disguised as science: foolishness, greed, and evil. I fear that all three are now hopelessly entangled.
Religion and science have important roles in our fight against the pandemic. Understanding the difference between them is a protection against deception. When someone says, “believe in science,” beware of fraud. Your life, your liberty, and your sacred treasures are at risk.
- Vaccine Booster Update
The FDA reshaped the vaccine landscape last week, authorizing single boosters for Moderna and Janssen vaccines, and permitting boosters from all vaccine manufacturers regardless of the initial vaccine brand. Here is an updated vaccine chart, incorporating these changes.
The changes were discussed at the two-day Advisory Committee Meeting on Vaccines and Related Biological Products Advisory Committee, held October 14-15, 2021. EUA applications for single boosters of Moderna and Janssen vaccines were unanimously recommended (4:26:25). The committee heard a report on the NIH “Mix and Match” study (5:27:26), the basis for the booster interchangeability authorization, but did not vote. After this meeting, FDA approved booster interchangeability and updated Fact Sheets for Healthcare Providers Administering Pfizer, Moderna, and Janssen vaccines. These Fact Sheets still say there is “no information on the co-administration” of vaccines. The rules for interchangeability between primary and booster vaccines are based on the vaccine used for the primary series. By these rules, anyone over 18 years old can get a Moderna or Pfizer booster 2 months after an initial Janseen injection.
FDA Approval means that a drug, treatment, or medical device has been licensed by the FDA for a particular purpose. Contrary to what you may hear, approval is not a guarantee of safety and efficacy. Rather, it means that the item in question has been through FDA’s rigorous gauntlet designed to prevent worthless or harmful products coming to market in the United States. Approval is different from authorization. FDA Authorization means that a product is available by Emergency Use Authorization, also known as EUA. The EUA process is designed to speed availability of products in the U.S. during an emergency. “Off Label” is a term used to describe use of an approved drug or device for a purpose other than its express licensed intent. Off label use of drugs is common practice. “Not authorized” is a term used to describe use of a drug or device which has neither been approved by the FDA nor made available by EUA.
Two key criteria for EUA are that an emergency exists, and there are no approved products to address the needs of the emergency. The continued availability of COVID vaccines under EUA is problematic on both points. First, as COVID-19 returns to endemic levels in many parts of the country, it’s debatable whether an emergency still exists. Once an emergency passes, and all EUAs, including the authorizations for vaccines, should be withdrawn. Second, there is an approved COVID vaccine: COMIRNATY. By approving a product that is not available in the U.S., the FDA has twisted itself into a pretzel. If the product is unavailable, it should not be approved. If the product is approved, EUAs for the other vaccines should be withdrawn. The FDA changes its call from heads to tails depending on how you flip the coin.
Expect two additional significant changes in coming weeks. The first will be the push to vaccinate children. The second will be the definition of “fully vaccinated” to include boosters. This will be followed by authorization for multiple boosters, meaning that you will always be just months away from losing your “fully vaccinated” status. Vaccine passports will then be a reality in the United States. Maybe that was the endgame all along.
Who would have thought this is where we would be 21 months ago?
- Break Free
The real division is not between conservatives and revolutionaries
but between authoritarians and libertarians
–George Orwell, 1948
The President is losing patience. Six quarters into the emergency, the FDA has authorized COVID-19 vaccines down to five years of age. The CDC maintains these vaccines are safe and effective. Vaccinations are mandated by powerful employers, high ranking generals, and top government officials. Most of the medical community are on board. Failure to comply costs income and freedom. It’s intimidating. Many have submitted to the pressure. These policies have concentrated authority and power in a few “experts” who presume to know what’s best for everyone else. It’s not just arrogance. It’s slavery.
Slavery doesn’t need a plantation and rows of cotton. Slavery occurs when one person owns the thoughts and actions of another. Motives don’t matter. Good intentions don’t justify coercion. Masters who treat their slaves well are still slaveowners. The core moral flaw of slavery is the notion that one person can own another. Slaves exist to serve masters, not the other way around.
Masters cannot make decisions in the best interest of their slaves. The interests of the slaveowner always have precedence. If you own my decisions, you own me. You can’t make the best decisions for me because you don’t know what’s important to me. The individual taking the risk must have decisive control. Today’s public health policies transfer choice from individuals to powerful experts just like slaves surrender control to their masters.
We don’t need experts to understand the issues of the pandemic. COVID-19 is bad. Many people have died, more than should have. But we’ve learned to identify those at risk. Sound, compassionate public health policy would focus attention on the vulnerable and protect them with more than vaccines. Instead, our masters are using only one tool and applying it universally.
Vaccines have risks. Many people have died, more than should have. Vaccines were rushed to market with only a thin veneer of study and testing. What we know of vaccine risks—myocarditis, blood clots, neuromuscular disorders, death—is scary enough. What we don’t know is even scarier. Some of these potential future problems can be deduced from the studies requested by the FDA in its COMIRNATY approval letter.
Yet our experts cling to a universal vaccination policy that seems to be less in the public interest than in that of vaccine vendors. Our impatient masters have cornered us into a company store where there’s only one shoddy product for sale. We must break free.
America is founded on liberty. Yes, our history is filled with cognitive dissonance on this point. The institution of slavery is baked into our founding documents, right alongside guarantees of individual rights and freedoms. But the understanding of liberty is also baked into Americans, so much so that we were willing to shed blood to purge slavery from our land, without the assurance that we could.
We’ve reached a similar moment. Echoing notes from the Gettysburg Address, history has given us the opportunity to purge a more occult and subversive form of slavery from our land. Our public health policies have devolved to the coercion by the few over the lives of the many. These policies have shifted from information to dogma, from recommendations to requirements. Like the slaves of old, we must adopt the religion of our masters and submit to their commands. Otherwise, we are promised discomfort.
To those subjected to these policies, my message is simple. Resist this coercion like it’s slavery. It is.
- Color Coded Vaccines
On October 29, the FDA removed the combined COMIRNATY/Pfizer-BioNTech Fact Sheet for Healthcare Providers. In its place, the FDA issued three new Fact Sheets for Healthcare Providers Administering Pfizer-BioNTech vaccines, one for each of the now three versions of the product which are distinguished by vial cap colors. Vaccine vials with purple caps are authorized for individuals 12 years of age and older and must be diluted before injection. Vaccine vials with orange caps are authorized for children 5-11 years of age and must be diluted before injected. Vaccine vials with gray caps are authorized for undiluted administration to individuals 12 years of age and older but are not available in the United States.
Sound complicated? It is. And it raises disturbing questions. But first, here’s an updated (and complicated) vaccine chart:
Now the questions.
Is there an FDA approved vaccine for children under 16 years of age?
No. COMIRNATY is FDA approved for individuals 16 years of age and older. Quoting from the Pfizer-BioNTech Orange Fact Sheet, “The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 5 years of age and older.”
Why did the FDA approve COMIRNATY if it’s not available in the United States?
I don’t know for sure, but I can speculate. The FDA News Release on August 23 makes it seem as if Pfizer-BioNTech is an approved vaccine. This may be the reason for COMIRNATY’s approval—to provide a veneer of legitimacy to the authorizations for boosters and child vaccines that followed. The Fact Sheets are clear: Pfizer-BioNTech vaccines are not approved. Not for anyone.
Why is COMIRNATY not yet available?
In the emergency use authorization letter for Pfizer-BioNTech reissued on August 23, the FDA acknowledged that, “There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses.” In other words, FDA will allow Pfizer’s inventory to be consumed under EUA before requiring production and distribution of COMIRNATY. By the way, you’ll have to go to web.archive.org to find this letter. I can no longer find it on FDA’s active website.
If COMIRNATY is not yet available because of Pfizer’s vaccine inventory, how does Pfizer manufacture two new versions (Gray and Orange) of its vaccine so quickly?
Good question. Is Pfizer just consuming inventory or is Pfizer producing new vaccine? I don’t know for sure, but it seems to me Pfizer is producing new vaccine.
Why did the FDA authorize Pfizer-BioNTech Gray if it’s not available in the United States?
I’m puzzled by this question. How can the FDA authorize use of an unapproved product for an emergency when that product is not available? If you have an idea, please tell me.
Are all COVID Vaccines experimental?
Yes. There is not an approved, licensed COVID vaccine available in the United States. All available vaccines are unapproved products permitted for emergency use only. It’s a big experiment. Vaccinated individuals are part of the experimental group. Unvaccinated individuals are part of the control group. We will analyze the results in a few years.
Can I or my child be forced to accept a COVID Vaccine?
No and Yes. Fact Sheets for Healthcare Workers Administering Vaccines say that the person administering the vaccine must disclose that “the recipient or their caregiver has the option to accept or refuse” the COVID-19 Vaccine. Fair enough, but this hasn’t prohibited vaccination by coercion. There are many people who have been forced to accept a COVID vaccine to keep their jobs, and people who refused vaccination have lost freedoms and employment. Coerced consent is and always will be unethical.
Are we sure Pfizer-BioNTech Orange COVID vaccines are safe for children?
No, and this is the most disturbing part of the October 29 actions. The CDC insists the vaccines are safe for children. But many prominent physicians have disputed this claim, saying that long term effects of vaccines on children are unknown. I agree. Without a time-machine, it’s impossible to know the future effects of vaccines given to children today. But I’m not the only one who thinks this way. At the 170th meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, Dr. Eric Ruben, Editor-in-Chief of the New England Journal of Medicine and temporary voting member of the committee, said, “We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.” Dr. Ruben voted for authorization of experimental vaccines in children. Whatever you think of his judgement, at least he’s honest about the safety data. We don’t have any yet.
- Censored
My most recent blog about vaccines for children was removed by LinkedIn because of a violation of LinkedIn’s Professional Community Policies. Although LinkedIn won’t tell me what specifically provoked removal of my article, I must have somehow run afoul of this sentence in their policy, “Do not share content that directly contradicts guidance from leading global health organizations and public health authorities.”
It’s not just LinkedIn. Twitter has a lengthy policy on COVID-19 tweets, including a ban on misleading information about “the safety or efficacy of treatments or preventative measures that are not approved by health authorities.” Referring again to “government health authorities,” Facebook’s policy explicitly lists examples of prohibited claims about vaccine effects such as “Bell’s palsy,” “blood clots,” “death,” or the emergence of a “new COVID-19 [sic] strain” with such authority that it would be an exquisite piece of satire if Facebook were not so sadly unaware of its naivety. I stopped looking for more examples of Big Tech’s holier-than-thou-know-it-all-ism quite confident that I could find as many as I wished.
The question is inescapable. When “health authorities” disagree, how does Big Tech decide which position is right and permissible, and which position is wrong and censorable? When an observation contradicts its orthodox viewpoint, Social Media labels it false and removes it. According to Thomas Kuhn in The Structure of Scientific Revolutions, unorthodox observations should be highlighted since they power the movement of scientific understanding.
But let’s not get into the science. Let’s talk about disagreements among government health authorities. About the same time that USFDA permitted Pfizer-BioNTech COVID-19 Vaccine for emergency use in children 5 to 11 years old, Taiwan halted plans for vaccinating those less than 12 years old, France’s Haute Autorité de Santé advised against Moderna vaccination for anyone less than 30 years old, Finland prohibited the vaccine in the same age group, and Denmark and Sweden prohibited its use in anyone under 18 years old. While other countries are restricting the use of mRNA vaccines in young people, USA is vaccinating preschoolers.
Outside government sponsored health organizations there is also disagreement about safety of vaccines in young people. Although 17 members of the Vaccines and Related Biological Products Advisory Committee voted that the benefits of vaccinating children aged 5 to 11 outweigh the risks, the opposite opinion is held by over 13,000 international physicians and scientists who have signed the Global Covid Summit Declaration II.
It’s clear there is a lack of consensus among “leading global health organizations” and “public health authorities.” Yet U.S. government officials are using intimidation, ridicule, and disregard for legal process to make it appear the issues driving its public health policy are settled. It’s just not true.
A vigorous public debate is needed, and social media could facilitate it. But social media is not content to be the platform for debate. Instead, it wants to control the outcome. Without years of deliberate study and armed only with a crash course in medical science, social media proclaims itself the ultimate health authority, deciding what observations are fit for public consideration and hiding the rest. Abandoning its journalistic legacy as the fourth estate, social media has become the stooge of government. Because the first amendment prevents it from doing so directly, the government is using social media as its proxy to restrict the speech of Americans.
It’s not funny. It’s no longer just our lives; the lives of our children are at stake. Just as physicians have a duty to “do no harm,” parents have a duty to prevent harm to their children. Quoting the best social media post I saw last week, “Don’t let your children die on the hill you refuse to fight on.”
- Boosters for All
Yesterday, the FDA revised the Factsheets for Providers Administering Pfizer BioNTech (both Purple and Gray) and Moderna COVID-19 Vaccines, permitting boosters of these unapproved products to Americans 18 years of age and older because of an ongoing emergency. The FDA took this action without reconvening the Vaccines and Related Biological Products Advisory Committee, a panel of national health authorities.
Yesterday’s action overrules the recommendation made by the Advisory Committee at its 167th meeting on September 17 when the panel voted 16-2 against the question, “Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?” True, the previous question was for 16 and above, not 18 and above, but the spirit of the committee discussion was for targeted boosters, not blanket boosters.
According to the FDA press release issued yesterday, “The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee on these actions as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of both Pfizer’s and Moderna’s EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.”
This action comes days after Alex Berenson, formerly of the New York Times, reported an error in Pfizer’s publicly reported safety data. Initially, Pfizer reported that two vaccine recipients died during trials, compared to four placebo recipients. In a July update, the count was revised to 21 deaths among vaccine recipients compared to only 17 in placebo recipients.
Then there’s FDA’s response to a freedom of information act (FOIA) request on Pfizer’s COVID-19 vaccine. Instead of transparency, the agency filed a petition in U.S. District Court to delay its response for 55 years.
Vaccine chart, updated for new EUAs issued on November 19, 2021. Up to now, I’ve just been reporting the news, but here comes commentary. These facts create a disturbing trend. What could they be hiding? I’m forced to one conclusion. The FDA and the pharmaceutical industry are colluding to coverup data and debate so they can sell vaccines. If you can reach another conclusion rationally, please tell me. I can’t.
The events of last week occurred in the open. Imagine what’s happening out of view.
- The Omicron Variant
A new variant is sweeping the globe. Today, the WHO designated the b.1.1.529 variant a Variant of Concern and assigned it the name Omicron, humorlessly passing on the opportunity call the new variant Nu. The Omicron variant, first identified earlier this month in South Africa, has already spread to Israel, Hong Kong, and Belgium, prompting travel restrictions by many countries.
There’s much more to learn about this variant, but reports so far suggest this is a highly mutated form with cluster mutations in the receptor binding domain, the portion of the spike protein where vaccine immunity is aimed. It’s reasonable to infer that these mutations may lead to increased vaccine escape. More breakthrough infections can be expected.
According to an article published in Nature yesterday, there are already anecdotal reports of reinfections and cases in vaccinated individuals. If the infectivity of Omicron is as least as high as Delta, expect Omicron to soon replace Delta as the dominant form in the U.S.
As the virus continues to evolve, the vaccines remain static. The vaccines available today were designed to provide immunity against the spike protein of the wild type strain identified in Wuhan in January 2020, but that viral strain has practically vanished. As the virus continues to move, individuals who are only protected by vaccination will be increasingly exposed to virus attacks.
Those who have been previously exposed to the virus can be expected to have broad immunity. Think of castle walls deflecting missiles launched from many directions and angles. Those protected by vaccine alone have neutralizing antibodies against the wild-type spike protein. Think of the protection provided by a slender pole. An attacker needs only move over a few feet to obtain a direct line of sight to the target. That’s why breakthrough infections are common, why vaccinated individuals can transmit the virus, why vaccinated individuals require hospitalization, and why vaccinated individuals die from COVID-19.
One more point about variants. The CDC now has four variant classes, listed from least to most significant: Variant Being Monitored (VBM), Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). In April 2020 there were many variants on the VOI and VOC lists. However, as vaccination rates increased, all but one of these variants disappeared from the United States and were moved to the VBM list, including the Alpha variant responsible for the COVID-19 spike last winter. The Delta variant and its rare sublineages are the only remaining Variants of Concern.
As the virus continues to evolve, a variety of variants should be expected, but instead we find a monotypic variant population. This suggests unnatural manipulation, and this observation is coincidental with the continued push for vaccination by a first-generation vaccine. Could there be a causal relationship? Could the Omicron variant be a result of the vaccination policy advocated by national and international health organizations? We don’t know for sure, but it is plausible. What we do know is that this virus will be with us for some time. Universal vaccination will not eradicate SARS-CoV-2. We must look elsewhere if we are going to live with the virus.
Early treatment shows the most promise.
- The Booster Trap
First, let’s clear up a misunderstanding. Some people think that a COVID booster is different from a COVID vaccine, but that’s not true. There is no difference between a manufacturer’s booster and its primary vaccine series. Both come from the same vial. There’s been no change in the formulas that were first authorized last year. Pfizer and Janssen boosters are even the dosed the same as a single shot from the primary series. Moderna boosters are half doses of a single shot from its primary series. Either way, the booster shot is just more of the same. If you want to fact-check me on this, read the FDA’s Fact Sheets for the Pfizer Purple, Moderna, and Janssen, the only available vaccines with boosters permitted in the U.S.
There are also those who believe that the vaccines available today are different that the vaccines that were given last winter, but that’s another misunderstanding. The original vaccine was targeted against the Wuhan strain, but even though that strain is no longer present in the community, vaccines given today are the same as the ones first authorized. There has been no change in vaccine formulas. You can fact check me by reading the FDA authorization letters for the available vaccines (Phizer, Moderna, and Janssen) which detail their regulatory histories.
Why the push for boosters? It turns out that the immune response induced by vaccine wanes significantly after 6 months. The booster is thought to drive antibody levels higher, and, the theory goes, it’s the antibody levels that protect the vaccinated from infection. Boosters have been authorized for all Americans over 18 years of age, 6 months after completion of an mRNA primary vaccine series (Pfizer and Moderna) or 2 months after the Janssen injection. Janssen’s booster interval is shorter because Janssen has the lowest immunogenic effect of the three authorized vaccines. Janssen-induced antibodies wane earlier.
Everything above this paragraph is an objective report of the current vaccine landscape. Now I’m going to predict the future. When I look in my crystal ball, here’s what I see coming.
Janssen will go from a single injection to a two-shot series, separated by 6-8 weeks. Then Janssen’s booster interval will be set at 6 months, just like the other vaccines. So far, only one booster has been authorized, but expect booster authorizations to go on an every six-month renewal cycle.
The definition of “fully vaccinated” will change to include a current booster. If it’s been more than six months since your last booster, your vaccination status will expire. It will take a computer to keep up with everyone’s expirations, so vaccine passports will be tracked on your smartphone. This passport will be connected to other data on your phone—where you go, what you tweet, who your friends are—to create a social credit score that will be used, along with your vaccine passport, to restrict or permit access to products, services, and transportation. Since your financial institutions are probably already connected to your smartphone, it will only take the flip of a switch to turn off access to buying power. That should incentivize citizens to maintain good scores.
And what about those boosters—will they ever change? Probably. The mRNA technology used in Pfizer and Moderna vaccines is a platform that can be adjusted rapidly to changing vaccination targets. As the virus mutates, these vaccines can be quickly reengineered to respond to the changes, perhaps even without additional FDA submissions. And it will be used for more than SARS-CoV-2. Other vaccine targets can be loaded on the platform to create a vaccination cocktail tailored to the pandemic du jour. And it will be used for more than vaccines. Other gene therapies can be mixed into the brew, all for your safety of course. You’ll be a much happier, more compliant, and easily manipulated citizen. The possibilities are endless.
What do you think of my crystal ball? Personally, I don’t like it very much. It’s not a world where I want to live. If my predictions become true, we lose the freedom to make personal choices. Free will, the essence of humanity, will be gone. That’s not for me.
We still have a choice. We can choose to go down this road of boosters without knowing where the road will lead, or we can recognize that vaccination will not eradicate this virus, no matter how many boosters we take. If boosters will not eradicate SARS-CoV-2, there must be another reason to inject the world with limitless mRNA sequences.
I don’t want to find out what that reason is, so I’m not going down that road. My humanity is too valuable to me.
- What If You Are Wrong?
I am not talking to President Biden, Rochelle Walensky, Anthony Fauci, or anyone else conflicted by political or material entanglements with the pharmaceutical industry. I am not talking to members of VRBPAC or ACIP, or principal investigators for NIH. I am not talking to Bill Gates, Mark Zuckerberg, or anyone who has made billions during the pandemic. I am not talking to anyone who has sold out. If you would do anything to hold onto your research grant, to keep your airline running, or to protect your fiefdom, I am not talking to you. I am not talking to media syndicates with synchronized messages. I am not talking to those cynical about the American dream who think “of the people, by the people, for the people” is naïve and passé twaddle. I am not talking to anyone numb to the pangs of conscience, sociopaths who prioritize greed and power over the lives of others. I am not talking to you because you are already lost. I have nothing to say to you.
I am talking to foot soldiers in the army of the people I am not talking to. I am talking to leaders who have power over people and policies. I am talking to those trying to keep their businesses safe for customers and employees. I am talking to hospital administrators responsible for protecting patients from harm. I am talking to doctors who care about the welfare of their patients. I am talking to elected officials trying to best represent their constituents. I am talking to leaders in the military and law enforcement who protect us from bad people. I am talking to dedicated scientists in public health agencies. I am talking to ethical small business owners. I am talking to HR directors responsible for a healthy and productive workforce. I am talking to all those who want to do the right thing. I know you are out there.
You are leaning on what has worked in the past. You steer a middle course. But as the pandemic evolves, the paradigms have diverged. It is no longer possible to keep one foot on the dock and the other in the boat; the middle ground is now under water. You have chosen the orthodoxy proclaimed by all the people I am not talking to. You feel safer there. Afterall, you are in a delicate situation. You know how things work. You are expected to be a good soldier and toe the line.
I’ve got a question for you. What if you are wrong?
You require vaccines for your employees, you urge boosters for your patients, because aggressive vaccination policies keep the public safe; the unvaccinated are a threat to the health of others. Vaccinate your employees, vaccinate your patients, vaccinate your children. Use the carrot, use the stick, but get it done. But what if universal vaccination will not eradicate the virus? What if the vaccinated can become infected and spread the virus to others? What if indiscriminate vaccination pressures the virus to mutate into more dangerous forms? What if antibody dependent enhancement causes devastating infections in the vaccinated?
You tell others that vaccines are safe and effective. You encourage your patients, your family, your friends to get boosted. Vaccine complications are rare, you say; COVID will shred your lungs, destroy the pleasures of taste and smell, and put you face down on a ventilator. But what if vaccine safety data has been deceptively manipulated? What if you learn of death spikes in populations after vaccines were introduced? What if there is collusion to suppress adverse vaccine safety information? What if the industry reports of vaccine efficacy deliberately leave out measures of absolute risk reduction?
You believe we must protect our children by early vaccination. But what do you do with the evidence that healthy children don’t die of COVID, that vaccination risks for kids far outweigh benefits, and that natural immunity in children is durable?
You say this crisis is no time to question the wisdom of our government’s healthcare policies. Afterall, they’ve been guided by the greatest minds on earth. But how do you feel when you learn that USA has more total per capita COVID-19 deaths than 90% of the nations on earth, and that during the pandemic, average lifespan of Americans has dropped by nearly 2 years, 8.5 times the rest of the developed world? How do you account for the thousands of physicians and scientists who have signed the Global Covid Declaration?
When the FDA tweets, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” you like it, you share it, but for sure you won’t prescribe Ivermectin or dispense it in your pharmacy. Afterall, there have been no adequately powered, well-designed, well-conducted clinical trials that support the use of Ivermectin in the treatment of COVID-19. You know that treatment for severe COVID is hospitalization, Remdesivir, steroids, and mechanical ventilation. But what if you learn that Remdesivir’s approval was based on inadequately powered, uncontrolled clinical trials that showed shortened hospitalizations instead of improved survival? What if you learned that early treatment keeps people out of the hospital? What if chloroquine prevents infection and spread of SARS viruses? What if the use of approved, off-label, unpatented, repurposed drugs by physicians is really generating the outstanding success rates reported by Front Line COVID-19 Critical Care Alliance, American’s Frontline Doctors, and the Pandemic Health Alliance? What if there has been a deliberate attempt to suppress alternative therapies for COVID-19? What if the leaders of institutions you have trusted for health guidance are manipulating you to enrich themselves and others?
Are you sure that your actions, your decisions, your influence, your mandates are not harming people?
Your decisions affect the welfare, livelihood, and very lives of others. And you are not just deciding for us; you are deciding for our children too. And their children. And all that come after.
Maybe you have been deceived. But what if you are wrong?
- More Testing Less Freedom
President Biden unveiled a new COVID initiative in a press conference this week. In addition to more COVID vaccinations, he promised more COVID testing. This is a bad idea which will create more fear and less freedom. Testing plays an important role in medical decision making, but indiscriminate testing can lead to harm. To be beneficial, the right test must be selected at the right time for the right reason. Let’s compare Biden’s testing plan against these three pillars of laboratory medicine.
The right test. The President promised free at-home tests. Although his speech was short on details, I think it is safe to assume he is talking about antigen tests which work much like at-home pregnancy tests. Antigen tests are fraught with technical and interpretative challenges, making it difficult to separate signal from noise. The result of increased antigen testing will necessarily be an increase in positive test results, many of which will be false positives. By contrast, PCR tests do a much better job of separating signal from noise. Although PCR test results are often misinterpreted, they have far fewer analytic false positives. President Biden’s plan increases availability of the wrong test.
The right time. There is no test for COVID-19, so the President’s call for increased “COVID” testing is technically incorrect. COVID-19 is a disease caused by SARS-CoV-2 infection. To have COVID-19, you must be infected by SARS-CoV-2 at the same time you have symptoms of a respiratory infection. Symptoms without SARS-CoV-2 infection is not COVID-19; SARS-CoV-2 infection without symptoms is not COVID-19. Why does this semantic detail matter? Because test timing is crucial to the diagnosis of COVID-19.
Test too early and an infectious person may have a negative result. Test too late and a person who is no longer infectious may have a positive result, no matter the quality of the test. This happens with PCR tests and antigen tests alike. Just like there is no morning-after pregnancy test, there is also no morning-after SARS-CoV-2 exposure test. Indiscriminate testing will lead to the wrong people isolating. There will be individuals who consider themselves safe because of a negative test result, and there will be individuals who disengage from society because of a positive test result. Both groups will be wrong because they test at the wrong time.
The right reason. Test results should drive actions; there is no other reason for testing. You should never test for curiosity, because you can, or to confirm a hunch. This is a testing trap that ensnares many of my clinical colleagues. By his call for “more testing,” it appears to have ensnared the President also. Before a test is performed, there must be a clear, distinct plan of action for each possible test outcome. If the actions are the same, the test should not be performed. The indiscriminate testing proposed will be used for the administration’s “vaccinate-or-test” plan. This is the wrong reason.
Vaccinate-or-test. In his press conference, President Biden reiterated his “vaccinate-or-test” plan to control social intercourse. His plan will fail to control viral spread since both of the plan’s foundational assumptions are false. The first assumption is that vaccinated individuals cannot spread infection, but it should be clear to everyone now that this is false. The second assumption is that individuals who test negative for SARS-CoV-2 cannot spread infection, but since the President proposes the wrong tests at the wrong time for the wrong reasons, this assumption is also false.
What will really happen because of the increased indiscriminate testing mandated by the President’s plan?
More Tests Less Freedom. When the wrong test is performed at the wrong time for the wrong reason, the absolute number of positive results will increase. Even though some of these positive results will be false and many will be insignificant, all these results will be counted as COVID “cases.” This is because early in the pandemic, the CDC changed its definition of a COVID-19 “case” from positive test and symptoms to positive test or symptoms. This “case” spike will be raised as a pitchfork to incite fear among Americans, and fearful people are more likely to turn loose of their liberty. Think I’m wrong? Consider this statement made by the President during his press conference:
And again, to folks who are not vaccinated: You may think you’re putting only yourself at risk, but it’s your choice. Your choice is not just a choice about you; it affects other people. You’re putting other people at risk — your loved ones, your friends, neighbors, strangers you run into. And your choice can be the difference between life or death.
Joe Biden, December 21, 2021See where this is going? “Vaccinate-or-test” will morph into a “vaccinate-or-isolate.” More testing will result in less freedom and more discrimination.
A Better Way. There is another way. If you feel sick, stay home. Find a doctor who will give you early treatment for COVID-19, and test as directed by your doctor. If early treatment doesn’t work, seek higher care at a hospital. When you feel better, go back to your life. Wear a mask for a while if you are concerned about infecting others. These are all commonsense rules taught to us by our parents and used for generations.
Never let test results make you afraid enough to let go of your freedoms.