Author: Kevin Homer, MD

Kevin Homer has practiced anatomic and clinical pathology at a community hospital in Texas since 1994.

Categories
Vaccine

Am I Up to Date?

Government health policy says Americans should be “up to date” with COVID-19 vaccines, but what does that mean?  To answer this question, I had a conversation with CDC’s website.  CDC responses are copied verbatim, correcting only misspellings and grammar for ease of reading.  Use the links if you want to check the responses for context.

KH: Why should I get a COVID-19 vaccine?

CDC: COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and even dying.

KH: Then all I need is a vaccination, right?

CDC: COVID-19 vaccines available in the United States are effective at protecting people—especially those that are boosted—from getting seriously ill, being hospitalized, and even dying.

KH: You’re saying that vaccination isn’t enough—I need a booster too?

CDC: You are protected best from COVID-19 when you stay up to date with the recommended vaccines.  You are up to date with your COVID-19 vaccines when you have received all doses in the primary series and all boosters recommended for you when you are eligible.

KH: How do I know what boosters are recommended for me?

CDC: Vaccine recommendations are different depending on your age, the vaccine you first received, and time since last dose.

KH: Let’s say I got Pfizer.  When am I fully vaccinated?

CDC: Two weeks after final dose in primary series.

KH: How long do I have to wait after my first dose before I can get my second one?

CDC: Three weeks (or 21 days) after the first dose.

KH: First dose, wait three weeks, then second dose, then wait two weeks, then I’ll be fully vaccinated, right?

CDC: People ages 6 months through 64 years, and especially males ages 12 through 39 years, may consider getting the second primary dose of an mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna) eight weeks after the first dose. 

KH: Why is that?

CDC: A longer time between the first and second primary doses may increase how much protection the vaccines offer, and further minimize the rare risk of heart problems, including myocarditis and pericarditis.

KH: Myocarditis!  That sounds serious.

CDC: There is a rare risk of myocarditis and pericarditis associated with mRNA COVID-19 vaccination, mostly among males ages 12 through 39 years.  Those who have been diagnosed with myocarditis should consult with their cardiologist (heart doctor) about return to exercise or sports.

KH: I don’t want to stop playing sports, so maybe I should wait eight weeks before my second shot.  Do I need a booster?

CDC: One booster, preferably of either Pfizer-BioNTech or Moderna COVID-19 vaccine, at least five months after the final dose in the primary series.

KH: I’m 59–just one booster?

CDC: Second booster of either Pfizer-BioNTech or Moderna COVID-19 vaccine for adults ages 50 years and older, at least four months after the first booster.

KH: Primary series—two shots—then two boosters.  I need four shots to be up to date?  What if I’m immunocompromised?

CDC: First dose-primary series; second dose-primary series three weeks after first dose; third dose-primary series at least four weeks after second dose; forth dose-booster at least three months after third dose; fifth dose-booster at least four months after forth dose.

KH: Five doses!  Is that safe?

CDC: The safety, effectiveness, and benefit of the third primary dose in people who are moderately or severely immunocompromised continues to be evaluated.

KH: Let me review.  You’re saying that to be up to date and fully vaccinated in the safest possible way, I should get my first shot, wait eight weeks (or did you say three weeks?), get my second shot, wait four more weeks (or is it eight weeks?), get my third shot (I’m immunocompromised, remember?), then wait three months (or is that five months?), get my fourth shot, wait four more months, then get my fifth shot.  How can I afford so many shots?

CDC: COVID-19 vaccines are available for everyone ages 6 months and older at no cost.

KH: Great!  Vaccine makers are sacrificing profits to give away vaccines to Americans.  How patriotic!

CDC: Vaccines were paid for with taxpayer dollars.

KH: Oh, I see.  COVID-19 vaccines are not free.  Taxpayers are paying vaccine makers for the shots given to fellow citizens…

CDC: …to all people living in the United States, regardless of health insurance or immigration status.

KH: You mean my tax dollars are paying for vaccines for all those people crossing the southern border illegally?

CDC: Jurisdictions (state, tribal, local, and territorial) cannot add U.S. citizenship requirements or require U.S. citizenship verification as a requirement for vaccination.

KH: Let me get this straight.  The government takes money from me and gives it to vaccine makers so that anyone living in the United States can access vaccines.  What do you call that?

CDC: If anyone asks you to pay for access to a COVID-19 vaccine, it’s a scam. 

KH: You said it.

Categories
COVID-19 Testing

Too Much Testing

Frustrated by misconceptions about SARS-CoV-2 testing, I began my career as an amateur blogger nearly two years ago.  I am motived by similar frustrations to write this blog today, but the source of today’s frustration is someone who should know better—the doctor to the President of the United States.

Joe Biden announced on Thursday, July 21, that he tested positive for COVID-19, despite being double vaccinated and double boosted.  Setting aside this fact as evidence that vaccination does not prevent future infection, that vaccination cannot eradicate the virus, and that current vaccinations stimulate immunity against the wrong target, I want to focus on the misuse of testing to perpetuate the COVID emergency.

On Wednesday the President’s doctor, Kevin O’Connor, DO, FAAFP, announced that Mr. Biden had repeatedly tested negative for SARS-CoV-2, and he lifted strict isolation measures.  But on Saturday, the doctor reported a positive antigen test.  He declared the President in relapse, blaming the same “Paxlovid rebound” that plagued Dr. Anthony Fauci during his infection in June.  In case you are wondering, Dr. Fauci also reports being fully vaccinated and up to date on boosters, and according to Dr. Fauci, his second round of symptoms were worse than his first.  In case you are also wondering, I had a single Janssen vaccine without booster ten months before my infection, and I suffered no “Hydroxychloroquine rebound” when I had omicron.  And I did not test.

Let me say this as plainly as possible.  

SARS-CoV-2 tests are not tests of cure.  They can tell you when someone is first infected by the virus, and that is all.  They cannot tell you when someone is rid of disease and no longer infectious.  The diagnosis of COVID-19 requires evidence of respiratory disease and a positive test for SARS-CoV-2.  Either one without the other is not COVID-19.  Despite the CDC’s redefinition midway through the pandemic, there is no laboratory test for COVID-19.

There are two types of SARS-CoV-2 tests—PCR tests and antigen tests.  PCR tests are highly sensitive, but positivity can persist for up to three months after infection.  During this period, tests are not reliable to identify reinfection, since any positive might just be remnants of the old infection.  Antigen tests are much less reliable.  Although an initial positive antigen test may indicate infection, negative tests do not mean a person is free of infection.  This has not changed since EUA testing began in 2020. 

If the President is subjected to daily testing, he may be diagnosed with many relapses in coming weeks, but that does not mean he still has COVID-19.  For that, doctors must rely on clinical observations.  The President’s doctor should know this.  He must know this.

Testing is being misused to perpetuate the COVID-19 emergency in our nation.  This episode illustrates the dangers of testing misuse and overuse.   We need a return of common sense, as much among doctors as among the public.  Testing should be limited and focused.  

We all know when we feel sick.  If you do, stay home, and seek early treatment, because early treatment keeps you out of the hospital.   I used the Zelenko protocol when I had Omicron.

When you feel better, return to your life.  We do not need tests for that.

Categories
Philosophy Science

The Art of Science

“When all was finished, it cannot be denied that this work has carried off the palm from all other statues, modern or ancient, Greek or Latin; no other artwork is equal to it in any respect, with such just proportion, beauty and excellence did Michelagnolo finish it.”  

Giorgio Vasari, 1550
Michelangelo’s David, 1501-1504

David, the breathtaking masterpiece by Michelangelo, represents the pinnacle of Renaissance sculpture, the result of countless hours in practice, planning, and observation of human forms.  Carved from a single massive block of Carrara marble which had been discarded by other sculptors, Michelangelo’s creation embodies confidence and power.  The body’s position, the facial expression, and even the veins popping in the neck all betray a determined youth on his quest to slay a giant.  You can learn a lot of anatomy, physiology, and psychology by studying David.  But nobody would confuse the statue with a living man.  

And why not?

This statue never moves, it is twice the size of a man, and it feels like cold stone instead of flesh.  Its proportions are wrong, perhaps intentionally so.  Cut it open, and you will find dust instead of a beating heart.  Michelangelo’s David is not a man.  It is just a model that provides ways to think about man.

Science is like that.  Like art, science is a creative endeavor.  Scientists do not discover truth any more than Michelangelo discovered David inside the stone.

For example, Sir Isaac Newton did not discover the law of gravity; he invented it.   His model replaced Aristotle’s 2,000-year-old idea that things fall because they seek their natural place in the universe.   Newton proposed that bodies attract each other in proportion to the product of their masses and inversely to the square of the distance between them [Fg = G(m1m2)/r2].  Both ideas explain why a cannonball dropped from a tower goes down, but only Newton’s model explains why the moon hangs in perpetual freefall around the earth.

Newton’s invention is elegant and useful, even taking men into space, but it is not true.  For example, Newton’s model fails to explain the wobbly orbit of Mercury.  To correct the deficiencies of Newton’s theory, Albert Einstein invented a model of gravity in which objects bend the unified field of spacetime, pushing them towards each other.  Although Einstein’s Theory of Relativity explains the paradoxical orbit of Mercury, even his invention has shortcomings.  In the subatomic world of Fermions and Bosons, Einstein’s theory just doesn’t work.

A model does not have to be universally true to be useful.  Despite its many limitations, science does two things incredibly well.  First, it shapes what you believe by informing on what is not true.  This is because the scientific method is an iterative process that tests ideas against independent observations.  Second, brilliant scientists compile observations into theories of various aspects of the universe.  In this way, scientists and artists have much in common.  Both create models that provide ways to conceptualize the complex, stimulating new thoughts and ideas.

Scientific models should not be confused with truth.  Truth is all around you, in nature.  Scientific models are ways to think about nature when you close your eyes, when your viewpoint is obstructed, when you cannot see nature clearly.  Scientific models are merely shadows like the ones on Plato’s cave.  The Allegory of the Cave described the art of science long before scientific principles were articulated.

Categories
Ethics Science Vaccine

Against the Rules

FDA made significant changes to COVID-19 vaccines available in the United States last week.  In its recent actions, the FDA displays pattern of blatant rule breaking that indicates negligence and corruption.  Here are three examples.

Pfizer.  FDA gave license to vaccinate middle-schoolers twelve years and older with COMIRNATY by its supplement approval letter of July 8, 2022.  This approval was issued in response to Pfizer’s submission of pediatric Study C4591001 regarding safety and effectiveness of COMIRNATY in children 12 through 15 years of age.  However, Pfizer reports that this study relied on data from a trial using 16 to 25 year-olds conducted prior to Delta and Omicron surges, raising questions regarding its relevance.

FDA rules require manufacturers to inform FDA within 6 months of “a permanent discontinuance in manufacturing”, or “an interruption that could lead to a meaningful disruption in the supply of the product in the United States” (page 7, lines 208-210), even if the manufacturer decides to cease production for business reasons (lines 221-222).  COMIRNATY has never been available in the United States in the eleven months since initial approval.  I am not an attorney, but this seems like a meaningful supply disruption of the licensed product to me, which should trigger a reconsideration of the vaccine’s license.  An expansion of COMIRNATY’s license while the product is still unavailable violates the spirit, if not the letter, of FDA’s own rules.  Instead, the approval appears to be merely a merit badge providing a marketing advantage to Pfizer without changing that fact that no approved vaccines are yet available to Americans.

Novavax.  The predicted authorization of the all-protein Novavax vaccine happened with fanfare last week.  FDA’s press release welcomed the arrival of “another option” for Americans, and assured that “the American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”  I have issues with both statements.

The use of emergency use authorization to provide “another option” violates the rules governing emergency use authorizations.  The purpose of the EUA is to make products available when “there are no adequate, approved, and available alternatives.”  There are approved alternatives—COMIRNATY and SPIKEVAX—which are, by manufacturers’ choice, unavailable.  But adequate alternatives are available.  Search vaccine.gov to see whether you can find vaccines in your area.  If you cannot, please let me know. If you can, another unapproved option is unneeded.

The assurance of “rigorous and comprehensive scientific and regulatory review” is misleading, since that describes the approval process, not the authorization process.  EUA is for emergencies, like bailing water out of a sinking ship.  “Rigorous and comprehensive” describes a process to assure seaworthiness before putting the ship into water and results in a license to sail.  Novavax has no license. It has not been through a truly rigorous and comprehensive scientific and regulatory review.

Moderna.  Authorization letters require manufacturers to comply with section 502(a) and (f) of the FD&C Act, which prohibits false or misleading labelling.  Yet children ages 6 through 11 are to be vaccinated with Moderna Purple, which is labelled “BOOSTER DOSES ONLY” because Moderna Teal is still unavailable.  Unreliable labelling is a setup for medical error, which is why the rules prohibiting misleading labels are so clear.  Instead of insisting that Moderna relabel product before distribution, FDA issued a “Dear Healthcare Provider” letter, instructing caregivers to ignore the printed label.

Vaccine chart, updated July 16, 2022.

This is the current state of vaccines in America.  We did not get here honestly.  Instead, we got here by bending, twisting, and breaking the rules established to keep us safe.

FDA is a law enforcement agency that should respect rules.  If you come under FDA’s jurisdiction, you rigorously follow its rules and regulations because FDA has the power to shut you down.  Just ask Abbott Nutrition, the operator of the Michigan baby food plant forced to cease production earlier this year.  The resulting baby formula shortage is a serious emergency, yet there have been no emergency use authorizations for manufacturers racing to have new product approved.  Meanwhile, we still have an emergency declaration that short-circuits the process for vaccines.

The FDA has compromised its rules related to vaccines.  It is a clear signal of negligence and corruption.  There is something pathologic at the FDA.

Categories
Science Vaccine

Medical Publications Bow to a Political Narrative Causing Loss of Public Trust

Publications in top-tier medical journals must comply with a narrative.  As a prerequisite for publication, authors must affirm that universal vaccination is the best response to pandemic, and that the benefits of vaccination outweigh any harm it causes.  Even articles that describe vaccine injuries must minimize their risks in deference to the goal of universal vaccination.  This misuse of the medical literature suborns the mission of journals to a political agenda, squandering the trust they once enjoyed.

I noticed this trend during research for these blogs.  Here are a few examples to give a flavor of the narrative.

  • In a recent review of clotting complications caused by vaccine published in Journal of Stroke and Cerebrovascular Diseases, Kakovan et al. end their article by saying, “Finally, since the advantages of COVID-19 vaccination outweigh the risk of stroke or any other neurological complication, the public should be reassured that the vaccination program is still the best way to combat COVID-19.”  The article gives no support for this conclusion.  It is as if the authors knew that homage to this dogma was the price of publication.
  • In a Reviews in Medical Virology article presenting data showing that vaccination causes a 13.6 times increase in myocarditis among 16-19 year-old males, Faziollahi et al. conclude that these complications are “rare,” missing this obvious data signal.  
  • “The very low prevalence of this complication of vaccination, however severe, relative to the benefits of preventing Covid-19 (a condition with 1 to 2% mortality and potential long-term sequelae) must be emphasized.” Clines and Bussel in New England Journal of Medicine.
  • “Independent safety reviews by regulatory authorities of available clinical and real-world evidence have concluded that the benefits of AZD1222 outweigh the potential risks.”  Falsey et al. in New England Journal of Medicine.
  • “The thromboembolic complications do not represent a contraindication to complete the vaccination cycle…” and “The vaccination for SARS-Cov-2 is essential to overcome the pandemic…” Serrao et al. in Journal of Thrombosis and Thrombolysis.

The narrative is fully stated in this quote from an article published in Journal of Clinical Medicine to help practitioners provide “evidence-based counseling to their often-alarmed patients” who have new blood clots after vaccination.  Abrignani et al. conclude,

“All scientific societies emphasize the value of continuing vaccination programs to protect patients from severe forms of COVID-19 and to slow the circulation of the virus and its variants. Vaccine hesitancy risks regressing progress in infectious disease control. Abstention is not an option, as it results in a failure to assist a large population that remains in danger. Action, with increased vigilance, is the best solution in our public health mission.”

Medical journals should be places of conflict, where ideas clash, paradigms are upended, and the status quo is challenged.  The New England Journal of Medicine claims, “Our mission is to publish the best research and information at the intersection of biomedical science and clinical practice and to present this information in understandable, clinically useful formats that inform health care practice and improve patient outcomes.”  But the crossroads of biomedical science and clinical practice is not a static location, unchanging over time.  Without medical journals exposing dangers of established practice, physicians might never have learned that diethylstilbestrol treatment causes cancer or that thalidomide therapy causes birth defects.  

Today’s medical journals have devolved into a repository of orthodoxy where platitudes are exchanged among the sanctified.  They bow to a narrative that coincides with a political agenda, mocking the missions of these publications.  The trust accumulated from two centuries of diligence and integrity has been lost in a few months.

The erosion of trust does not stop with the journals.  It extends to my entire profession of physicians. Yet too few of my colleagues have acknowledged this trend.  Instead, most parrot the narrative to their patients.  Why?  Are they afraid they will never be published again?  Are they afraid they will be ostracized from the society of physicians and scientists?  Or are they just too lazy to observe and think for themselves?

Physicians have a sacred duty to the patient in front of them.  This duty requires honest observation, independent thought, and attention to the patient’s best interest.  Without these, we deserve the loss of public trust.

Categories
COVID-19

I Had Omicron

I am pretty sure I had Omicron in January.  I say “pretty sure” because I did not confirm infection with a PCR test.  By now you know why I think most of these tests are unnecessary.  It felt like a cold, and a rather mild cold at that.  Most people in my family had the same symptoms; I encouraged them not to test, and they did not.  I remember that people around me felt sick too—some took time off work, some blamed allergies.  I am pretty sure it was COVID.  

We were on vacation at the time, lest you worry I spread my infection to sick people, although I did take a flight home while still stuffy.  Masks on airplanes were still mandatory at the time.  

But I hedged my bets.  I took hydroxychloroquine for a week.  I tripled my daily vitamin D, did daily nasal washes, and started taking Dr. Zelenko’s Z-stack vitamins (I haven’t stopped taking those).  I never lost taste; I never lost smell.  It took me a month to shake the sniffles, but nothing else lasted more than 36 hours.  

My wife, Liz, never felt ill.  She has lupus and has taken hydroxychloroquine for years.  Maybe that is why.  

Back up a bit.  I am pretty sure we avoided COVID before then.  Liz and I were extra careful.  She has an autoimmune disease, and I work near sick people.  We weren’t taking any chances.  We cancelled vacation plans (not the vacations, just the plans), and found we could live quite comfortably—enjoyably, even—at home.  Alone.  We did not go out to eat.  We stopped shopping in the mall.  We became friends with Doordashers, the Amazon Delivery persons, and other deliverers of our on-line shopping selections—at an appropriate social distance, of course.  We picked up groceries curbside.  We went out rarely, and when we did, we masked religiously.

We both took Johnson and Johnson vaccines in March 2021, and my wife instantly had a lupus flare.  The migraines which she had previously experienced once a month became daily, painful affairs.  She had to change medications to a more powerful and (any surprise?) much more expensive drug.  She still has ringing in her ears and extra pain in her joints that she dates from the shot.  Migraines are no longer daily, but still more frequent than before.  I was skeptical of mRNA technology from the start, but I regret the decision to take a vaccine.

I am a curious person, and life had presented us with the opportunity to study something that had never been studied before.  I began measuring antibody levels in friends and colleagues who had made a variety of choices about vaccination and COVID precautions.  We identified some people who had had COVID but did not know it.  We identified people who had COVID after vaccine.  We learned early on that Moderna produces the highest immune response, and we learned that vaccine did not add much immunity to people who had disease.  Some people, including me, had little immune response to vaccine.

The antibody tests available then were not very good, and they kept changing, making it impossible to track serology over time.  That is why Liz and I joined the TXCares study.  After answering some questions, we measured the S-protein and N-protein antibodies in our blood three times over six months.  Here are our results:

S-antibodies (S-Ab) can come from either infection or vaccine, but N-antibodies (N-Ab) can come only from infection.  Since our S- and N-antibodies increased in February, I am pretty sure we had COVID in January during the Omicron wave.  

Antibody tests are still not very good.  For example, I consider the change in N-protein levels from nil to barely detectable significant, even though our levels did not reach the arbitrary positive level of 1.  But at least these tests were consistent over time, and the results corresponded with our clinical history.

How do I feel now?  For starters, we are not scared of COVID anymore.  We do not mask (except at the hospital), we do not avoid people, and we shake hands again.  The only current lifestyle impact is the continued coercion to vaccinate.  If an activity requires a vaccine card, we avoid it.  That means we still do not travel internationally, and we do not patronize certain entertainment venues, including, regrettably, venues we once loved.  But that is it.  Otherwise, we are normal again.  Well, maybe not quite.  My wife’s lupus is worse, and I have a positive d-Dimer, but that is a story for another day.

Antibody levels consistently and reliably inform on immunity, yet they are spectacularly underutilized.  Perhaps this is because they are spectacularly inexpensive.  Consistent, reliable, and actionable information is not what the game is about right now.  If spike protein antibodies are a good thing, and I am still not sure they are, Liz and I have plenty to spare.  But we were going to have them sooner or later.  COVID is not going away until most of us catch the virus.  Vaccinated or not, most of us have.

Categories
Vaccine

Regulatory Capture

Up to now, all the vaccines have been the same.  The only differences in the vials are the concentrations of genetic material for various age groups and boosters.  As the virus continues to mutate at a rapid pace, current vaccines are becoming irrelevant.  That may be about to change, but not for better.  The roadmap to release of future vaccine versions will be the subject of the FDA’s Vaccines and Related Biological Products Advisory Committee meeting on Tuesday.  This plan could open the door to genetic engineering without safety oversight. 

Simplicity and standardization reduce error, yet vaccine rules are becoming more complex.  Instead of mandating standardization, the FDA has allowed manufacturers to establish packaging, dosing, and interval parameters.  This is the result of regulatory capture—regulators overtaken by those they are charged with regulating.  Regulatory capture has caused FDA to authorize so many versions that it is easy to forget there are still just three vaccines available in the United States.  

Pfizer, Moderna, and Janssen vaccines have not changed since their introductions.  All three are designed to produce immunity against a virus which is no longer a threat.  Although the many different vials in the Pfizer and Moderna vaccine families make it appear these companies have been hard at work making new vaccines, they only adjusted the product concentrations and doses for different age groups and boosters without the slightest change in the immunity target.  We’re skating to where to puck has been, not to where it is going.  

The FDA and vaccine manufacturers are aware of the problem.  Like the needlessly complicated vaccine landscape, their solution will be another example of regulatory capture.  If approved, future Covid-19 vaccines versions will skip clinical trials.  The manufacturer can change the genetic material in these vaccines without understanding the consequences of the change.  If you want plan details, read this Substack article by Dr. Toby Rogers of Brownstone Institute.

Why is this dangerous?  Afterall, if we are going to keep up with this virus, shouldn’t we give scientists the freedom to engineer the vaccines on the fly?

The first problem with this idea is that scientists do not know what they are doing.  Because the understanding of genetics and immunology is incomplete, we cannot expect scientists to flawlessly produce genetic code that is safe for human injection.  If I download and install a hack I find online, the worst outcome is a bricked phone (it’s happened; ask my wife).  If genetic engineers make a mistake, the consequences are frightful—think Zombie movies, Frankenstein, and Jurassic Park.  Afterall, they are tinkering with the operating system of life.  Genetic engineering should require more oversight, not less.

The motives of vaccine manufacturers represent a worse problem.  These companies have a duty to their boards and shareholders that supersedes the health and wellbeing of their customers.  We regulate the healthcare industry for this reason.  If we give pharmaceutical companies license to sell untested versions of genetic code, they will use it to bulk up balance sheets.  Honest clinical trials are the only way to check these corrupt intentions.

We must get integrity back into the oversight and approval process, and we do this by getting the money and corruption out.  Safety cannot be ensured when studies performed at universities and published in journals by scientists are presented to advisory committees.  At least not when the company pays for the study, endows the university, advertises in the journal, pays royalties to the scientists, and funds committee member projects.  These cozy arrangements must end.  Anti-kickback laws must apply to all parties in the biomedical-industrial-regulatory complex.

Categories
Vaccine

Why Is the Vaccine Landscape So Complicated?

Ten months ago, I posted the first Quick Chart on COVID Vaccines to aid in understanding the increasingly complex vaccine landscape.  Today, I’m revising the chart for the sixth time to include new information contained in fourteen Fact Sheets released by the FDA on Friday.  These Fact Sheets cover eleven vaccine versions from three manufacturers, each with unique cap color, label border color, dilution volume, dose volume, and dose interval, all dependent on the age of the recipient.  The Fact Sheets supersede (see under “Storage and Handling, page 3) package inserts and vial labels which are now obsolete and unreliable.  These emergency vaccine authorizations cover all Americans, literally cradle to grave, from age 6 months until death.  The exploding complexity is based on whim, not science, as Dr. Anthony Fauci acknowledged last week.

Vaccine Chart compiled from Fact Sheets for Health Care Providers, June 2022

The chart above is compiled from all Fact Sheets for Health Care Providers, which you can find in these indexes for Pfizer, Moderna, and Janssen.  I have done diligence to ensure accuracy, but given the extreme complexity, I cannot be liable for errors.  Errors on the chart could be embarrassing to me.  Errors in administration of vaccine could have disastrous consequences for vaccine recipients, so the FDA also published wall charts for Pfizer and Moderna vaccine families for reference.

Pfizer Wall Chart
Moderna Wall Chart

While tabulating information, I noticed some interesting language.

First, FDA gives a new justification for the persistence of Emergency Use Authorizations for vaccines that have approved versions.  Footnote 16 of the reissued ModernaTX Authorization Letter reads,  “Although SPIKEVAX (COVID-19 Vaccine, mRNA) and Comirnaty (COVID-19 Vaccine, mRNA) are approved to prevent COVID-19 in certain individuals within the scope of the Moderna COVID-19 Vaccine authorization, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.”  Of course, this is a sham.  Moderna will never produce enough SPIKEVAX for distribution to the entire population so long as it can produce vaccines for emergency use which have liability protection.     

Second, Moderna Teal, packaged for age 6 through 11 years, is not currently available (see Fact Sheet bullet at top of page 2).  Instead, 6 through 11-year-old children are to receive Moderna Purple, labeled “BOOSTER DOSES ONLY,” as their primary series vaccine (see Fact Sheet bullet at bottom of page 1).  Presumably, the Moderna Purple and Teal formulations are the same, but “Moderna COVID-19 Vaccine is not authorized to provide booster doses to individuals 6 years through 11 years of age.”  Only Pfizer Orange is authorized for booster doses in children under 12 years old.

Finally, all other mRNA vaccines have a two shot primary series with a third shot for the severely immunocompromised, but not Pfizer Maroon.  All infants and toddlers get a three shot primary series when vaccinated with Pfizer.

Why is this so complicated?  There must be very sophisticated data and detailed scientific analysis to produce these dosing rules for primary series and boosters.  Some really smart people must have worked all that out for us.

No.  These rules are based on conjecture and assumption, not science.  For example, according to Dr. Fauci, there are no studies supporting boosters for kids, yet boosters for kids were authorized by FDA last week.  But don’t take my word for it.  Watch for yourself and decide.

If science is not driving the complicated vaccine landscape, there must be another reason.   My hunch—follow the money.

Categories
Ethics Vaccine

Why Vaccinating Kids Is an Emergency

This week the FDA’s Vaccines and Related Biological Products Advisory Committee will meet twice to consider COVID-19 emergency use authorizations for children.  On Tuesday, June 14 the committee will consider Moderna’s request to vaccinate children aged 6 through 17, and on Wednesday, June 15, the committee will consider requests from Pfizer and Moderna to vaccinate all children and infants down to six months of age.  Infants and children have the lowest death rate from COVID and the highest risk for adverse health consequences, so why is vaccinating children an emergency?

Kids die from COVID-19, but the death rate is astonishingly low, especially when compared to other childhood risks.  According to the American Academy of Pediatrics, between 0.00% and 0.02% of all COVID-19 cases in U.S. children result in death.  As of June 2, 2022, there have been 1,049 childhood deaths from COVID-19, total.  By comparison, in 2019 nearly 2,400 teenagers died in car accidents, and 1,250 infants died of SIDS.  Yet, any childhood death is tragic.  If vaccination reduces death from COVID-19, why not vaccinate our children to reduce even this tiny risk?

An honest risk-benefit analysis requires examination of both sides of the equation, so we must first look at the risks of vaccine in children.

Many of these risks are still unknown.  The kids who have been vaccinated have not grown up, entered the workforce, or had children.  Nevertheless, sobering data is emerging.  Vaccinated males between 16 and 19 years old have a 13.6 increase incidence of myocarditis compared to historical norms.  So far, there have been 52 deaths reported to VAERS after COVID-19 vaccine in children aged 6 months to 17 years.  Reports of blood clots in vaccinated children are beginning to surface, unsurprising since thrombotic vaccine risks in adults are well established.  According to data released by Pfizer, vaccination is associated with increased miscarriages.  Perhaps most compelling, the study funded by Pfizer and published in the New England Journal of Medicine to support vaccine administration in children shows no improvement in all-cause mortality (see table S2).

And we still have those risks of the unknown.  Read again how a seemingly harmless hormone caused cancer in the daughters of women injected with it.  

If it is hard to reconcile the risk-benefit in favor of vaccinating kids, there must be another reason for the push to do so.  Perhaps it is not a health emergency for children but a liability emergency for vaccine manufacturers.  Vaccine liability protection will evaporate once the COVID-19 emergency is lifted, but childhood vaccines enjoy special liability protection.  

Emergency Use Authorization makes unapproved products—vaccines, tests, treatments, and so on—available during a public health emergency when there is nothing approved that works.  Manufacturers do not want to be liable for unintended consequences of unapproved products. Although an EUA does not by itself provide product liability protection, there is a loophole.  The Secretary of HHS can issue a PREP Act Declaration which absolves manufactures from all liability except willful misconduct for claims “resulting from administration or use of countermeasures to diseases, threats and conditions.”

The HHS Secretary issued a PREP Act Declaration for COVID-19 that includes vaccines, granting liability protection for as long as the emergency lasts.  It has been extended 10 times.  But the emergency cannot go on forever.  The end game is permanent liability protection.  

In 1986, congress passed the National Childhood Vaccine Injury Act (NCVIA) which created the National Vaccine Injury Compensation Program, “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”  If you can prove vaccine injury, you can ask for financial compensation from the fund rather than file lawsuit against the manufacturer.  This system is open to “any individual, of any age, who received a covered vaccine,” but there is a catch:

For a vaccine to be covered, the Centers for Disease Control and Prevention (CDC) must recommend the category of vaccine for routine administration to children or pregnant women…

Heath Services and Resources Administration definition of Covered Vaccines.

Currently, COVID-19 vaccine manufacturers have liability protection because they are selling unlicensed products under emergency use authorization.  But once these products are recommended for routine administration to children or pregnant women, then vaccine liability protection will continue under the NCVIA, even when the emergency declaration is lifted.

Now we know why vaccinating children is an emergency.  At the same time, we have stumbled on the answer to a question I asked a few weeks ago.  Why does CDC recommend COVID-19 vaccines to pregnant women, despite the explicit Fact Sheet statements (see page 44) warning of the lack of safety data? 

The answer to both questions is the same.  Like vaccinating pregnant women, vaccinating children gives manufacturers a pathway to permanent liability protection.

Categories
Science Vaccine

The Novafix

On Tuesday, June 7, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will consider evidence supporting emergency use of Novavax COVID-19 Vaccine.  The outcome of these proceedings is nearly certain.  The committee’s endorsement will be followed by a swift EUA letter from the FDA and recommendation by the CDC.  The only uncertainty is how many times committee members will contradict previous statements in their sycophantic rush to fawn over this new all-protein vaccine.

FDA Placeholder for Novavax Fact Sheet, June 5, 2022.

FDA webmasters have already been hard at work, excavating a location for the new vaccine’s authorization documents.  Click here today and you will see the placeholder for the Novavax Recipient-Caregiver Fact Sheet.  Next week, the same link will bring up the actual documents.

Wall Street is also lining up behind the new vaccine.  According to a recent article published on Nasdaq.com, “So far, in all previous global regulatory approvals in other regions, there has been ‘minimal to no debate’ on the highly effective and safe credentials of the vaccine as shown in the 3 large-scale Phase 3 studies. And going by previous examples of such EUA FDA panels, following a positive vote by VRBPAC panelists, Mamtani [an analyst working for B. Riley Financial] expects a ‘prompt FDA approval.’”

The article continues, “Accordingly, Mamtani reiterated a Buy rating on NVAX shares, backed by a $181 price target. Investors stand to take home about 227% gain, should the target be met over the next 12 months.”  This is Mr. Mamtani’s recommendation, not mine.  I am a practicing pathologist and do not give financial advice.  I only reference this article to restate a previous point—this is about the money.

The fix is in.  As Wall Street proclaims this new vaccine “highly effective and safe,” expect committee members to opine at length that the new vaccine is new technology.  Since it does not use mRNA, it should be readily accepted by the unvaccinated holdouts by removing their objection to gene therapy.  Obsequious committee members will heap praise on the company for producing this missing piece to the pandemic puzzle.

Their praise will create a contradiction that undermines the committee’s credibility.  If the war on pandemic requires another vaccine, then the vaccines currently available must not be the panacea we were told previously.  To believe what the committee will say this week, we must stop believing that what the committee said previously about mRNA vaccines being “safe and effective.”  Maybe they are not safe enough or not effective enough.  Otherwise, why would a new vaccine meet requirements for emergency use authorization?  And if we must stop believing something they have said before, why should we believe them now?  This is not science.  This is politics.

Tuesday’s committee discussion will not recognize any of the problems with the Phase 3 trial published in the New England Journal of Medicine earlier this year.  They will not consider the failure of vaccine to reduce all-cause mortality, the high number of short-term adverse effects, or the elimination of the control group after two months.  They will simply parrot the study’s conclusion of “safe and effective” without critical examination of the study’s flaws, and without mentioning that the study that was funded by the vaccine maker.

By the end of the week, a new vaccine will be available to Americans.  The new vaccine will not met rigorous approval standards, but it will have the same manufacturer liability exemptions as the other EUA vaccines.  Novavax stands to make a lot of money with minimal risk.  However, there is little evidence that this new vaccine will create a health benefit for Americans.