Categories
2023 COVID-19 Testing Vaccine

Emergency Use Authorizations in a Post-Emergency World

According to the U.S. Department of Health and Human Services (HHS), the COVID-19 Public Health Emergency will expire in May, but Emergency Use Authorizations and liability protection will continue after the emergency ends.

Early in the pandemic, we were told that Emergency Use Authorizations were necessary to make unlicensed, unapproved tests, vaccines, and treatments available during an emergency.  On January 31, 2020, the Health and Human Services Secretary declared the COVID-19 pandemic a public health emergency, paving the way for these products.  The secretary even invoked the liability protection of the PREP Act to encourage manufacturing of countermeasures.  Soon, the FDA began issuing Emergency Use Authorization letters which close with a notice that the authorization will terminate when the emergency is over.

Last month, the HHS secretary signaled his intention to end the emergency on May 11, 2023.  At the same time, the secretary assured us that Emergency Use Authorizations will not be affected.  According to the statement, “Existing EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.”

The Federal Food, Drug, and Cosmetic Act was amended several times by the Consolidated Appropriations Act, 2023 (see page 1339, for example).  Did these amendments give FDA authority to issue EUAs without an emergency?  I cannot tell you because, frankly, I get lost in the language.  HHS claims its authority for EUAs in the absence of an emergency declaration dates back a decade, to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.  Regardless, the intention is clear: EUAs will continue after the emergency is lifted.

And what will become of those PREP Act liability protections?  According to HHS, these will also continue, but only for a select group of manufacturers:

Currently, the amended PREP Act declaration provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a USG [United States Government] agreement (e.g., manufacturing, distribution, or administration of the countermeasures subject to a federal contract, provider agreement, or memorandum of understanding). That coverage will not be affected by the end of the PHE. However, PREP Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for area where countermeasures are administered. HHS is currently reviewing whether to continue to provide this coverage going forward.

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, February 9, 2023

Manufacturers of EUA products that have an agreement with the US Government will continue to have liability protection.  Other manufacturers will not.  Collusion between the federal government and big businesses like this asymmetric post-emergency liability protection is the very definition of fascism.  

If Emergency-Use-Authorizations without an emergency seem illogical to you, you are not alone.  Even members of congress have assumed that EUAs will end with the emergency declaration.  

This is not just an assault on language and logic.  It is an assault on liberty.  

The emergency declaration will end soon, but the emergency power-grab will continue indefinitely.

Categories
Testing Vaccine

Institutionalized Misconceptions

The CDC quietly changed its COVID guidance last week.  In an August 11 update to Isolation and Precautions for People with COVID-19, the CDC removed the vaccination advantage for ending COVID-19 isolation.  Now the CDC expects everyone to follow the same isolation guidance, regardless of vaccination status.  Yet even its newest guidance perpetuates myths that extend the COVID emergency unnecessarily.

Here is the new guidance.  If you suspect you have COVID-19, you should test.  Isolate until you receive your test result.  If your test is negative, end isolation.  Asymptomatic individuals with a positive test should isolate for five days and wear a mask for ten.  If your test is positive and you have symptoms, isolate for five days from the first day of your symptoms or for 24 hours after you are fever-free, whichever is longer.  Mask for ten days.  Better yet, mask until you have had two negative antigen tests 48 hours apart.

Previously, CDC recommended different isolation protocols depending on vaccination and booster status.  Now there is no difference, another tacit admission that the vaccinated and unvaccinated spread infection similarly.  This is a softening of its once bellicose “Pandemic of the Unvaccinated” position, and not the first time either.  In the last paragraph of a June MMWR report, the CDC admitted, “Despite the introduction of highly effective vaccines and medications to treat COVID-19, by the end of the study period, COVID-19 continued to cause substantial morbidity and mortality.”  Hopefully, this new direction will reduce fuel for those actively practicing health discrimination against the unvaccinated, or against the vaccinated but not up-to-date.

I am not holding my breath.  There continues to be a lot of momentum in that direction.

Despite this small positive, the new guidance continues to perpetuate misconceptions that have been institutionalized within the CDC.  Here are three examples.

There is a test for COVID-19.  The CDC confuses a SARS-CoV-2 test with COVID-19, something this blog has warned against since the early days of the pandemic, but which has become an institutionalized misconception at the CDC.  There is not a test for COVID-19.  Symptoms are necessary for diagnosis.  

Asymptomatic individuals should be tested.  Different guidance for those with and without symptoms implies a recommendation for testing asymptomatic individuals.  “Asymptomatic spread” is an unsubstantiated idea at best and deliberate fearmongering at worst.  Guidelines that promote asymptomatic testing perpetuate the myth that “asymptomatic spread” is a real concern, effectively prolonging the emergency.  Testing should be limited and focused.

Tests can determine when to end isolation. The updated guidance uses test results instead of symptoms to end of the isolation period.  This misconception relies on the assumption that an individual who has tested negative is unlikely to spread infection.  The fallacy of this assumption is embedded in the guidance, which requires two consecutive negative antigen tests to end masking.  Why two tests?  Antigen tests have low sensitivity, meaning lots of false negative results.  If the first test is not reliable, should the second test be any better?  “Past performance is no guarantee of future results.”—that works for investing and for testing.  The guidance might as well say, “Flip a coin every 48 hours; leave your mask on until you get two heads in a row.”  SARS-CoV-2 tests do not test for cure of COVID-19.  

Many people just ignore the CDC, but there are those who live in trauma and fear unnecessarily.  Misconceptions institutionalized by the CDC trap those individuals in a cycle of stress and panic.  It is time for sensible, uncomplicated, time-tested guidance.

If you feel sick, stay home.  When you feel better, get on with your life.

Stop scaring people already.

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, FAAFPannounced 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
COVID-19 Science Testing Vaccine

End Games

The pandemic is over.  Sure, a few hot spots remain, and SARS-CoV-2 continues to smolder as variants of the original virus, but this is our post-pandemic world.  COVID will never be eradicated; there will always be endemic disease where there are human communities.  But the worldwide pandemic, the catalyst for the “emergency”, has passed.  This emergency created an alliance between power hungry authoritarians and money hungry profiteers, resulting in a loss of individual freedom and massive wealth redistribution.  

This alliance has not ended with the COVID emergency.  Politicians and the industrialists will continue to conspire to secure the profits and power usurped during the past two years, and they will do this by playing games.  Get ready for the end games.

Many of these games will be played with emergency use authorizations (EUAs).   Medical devices and therapies developed during the pandemic continue to be available under EUA for as long as HHS Secretary determines that there is an emergency warranting use of unapproved products.  On April 12, 2022, Xavier Becerra renewed the declaration, extending the emergency into July.  But does anyone think that a true emergency still exists?  As COVID restrictions are lifted, the only reason for the continued “emergency” is to prolong the availability of these profitable medical devices and therapies. 

Manufacturers would rather operate under EUA than under FDA license because of relaxed manufacturing standards and minimal product liability, but the beneficiaries of the emergency know this state cannot not last forever.  They intend to ride the EUAs until the end, then jump over to FDA approval at the last possible moment so their profits continue after the lifting of the emergency declaration.

These end games are baked into the pre-pandemic language governing EUAs.  The Secretary of HHS is required to give adequate warning before terminating an emergency so that manufacturers may dispose of their outstanding inventory.  Last month, FDA issued draft language outlining a transition plan from EUA to approval for medical devices, including PPE equipment and diagnostic tests.  Expect similar plans for drugs and vaccines.  

Pfizer and Moderna have already pocketed approvals for COMIRNATY and SPIKEVAX without bringing these products to market.  Once the emergency ends, these vaccines will magically materialize.  But before the state of emergency is lifted, vaccines will be approved for all age groups, as will perpetual and unlimited boosters. 

The same will be true for other expensive, patentable COVID drugs such as Evusheld and bebtelovimab, drugs designed for pre-exposure and early treatment and now only available by EUA. Before the emergency is lifted, there will be a push for FDA approval by the same forces that conspire to prevent access to Hydroxychloroquine and Ivermectin which have been used for the same purposes.  The existence of these unpatentable drugs should have precluded EUAs for the profitable ones. 

Another game is being played with tests.  Early in the pandemic, the CDC quietly changed the definition of cases to mean a positive diagnostic test regardless of symptoms.  This change drives up the case rate numerator without changing the denominator.  These inflated test results will be used to prolong the emergency declaration for as long as possible, stretching the advantageous EUA business environment.  With few exceptions, SARS-CoV-2 tests are available by EUA, but these will be quickly approved before emergency is lifted, since direct viral tests are useful to perpetuate fear in a sensitized population. 

By the way, do not expect antibody tests to be approved any time soon.  Antibody tests should be the gold standard for assessing immune status—better than vaccination history, better than disease history.  But these tests are still shockingly primitive.  No interpretative standards have been developed, and few careful serologic studies have been undertaken.  And no wonder.  The potential clarity of antibody tests benefit neither the profiteers nor the authoritarians.

And what do the authoritarians get by playing these games with the profiteers?  Power.  In exchange for their friction-free money machines, businesses have facilitated the authoritarian’s assault on civil liberties.  Businesses use a variety of techniques to steal liberties from individuals.  Some of these liberties are surrendered freely by appeals to conscience and duty.  Other liberties are taken by coercion.  But when force is required, businesses provide the muscle.  Hospitals fire employees that refuse to comply with the CMS vaccine mandate.  Airlines enforced the CDC transit mask mandate, and may do so again.  Neither mandate is supported by evidence.

The current powerful alliance of big business and big government fulfills the criteria of fascism.  Americans have been here before.  To overturn this instance of fascism, we need coalitions of citizens committed to truth and individual liberty.  Our greatest hope is rekindling the American Spirit. 

Categories
2022 COVID-19 Testing

Free Tests We Cannot Afford

A new crisis has been spawned by the pandemic.  This crisis was announced by the President in December, and it will consume more and more bandwidth in coming months.  It is the crisis of testing.  This is a fabricated crisis, unrelated to people’s health.  This crisis is a distraction designed to perpetuate the pandemic so that more of your wealth can be transferred from public coffers into the pockets of special interests.

On December 21, in the same speech that introduced the testing crisis, the President  announced an initiative to make 500 million free tests available to Americans.  These tests can be ordered “free of charge” at covidtests.gov, and they will delivered to your home by the US postal service.  Furthermore, the government has “incentivized” insurance companies to reimburse Americans for over-the-counter tests, up to eight tests per covered individual per month.

As Omicron burns through the country, it’s time for a dose of common sense.  Omicron is mild.  With over-the-counter medications and the advice of Front-Line doctors, most people can recover at home, without a test. 

Many people think that a negative test means that you cannot infect others, but that is not the case.  PCR tests have issues, but over-the-counter tests are antigen tests, and antigen tests are notoriously unreliable.  Using manufacturers’ submission data, over-the-counter tests have average sensitivity confidence intervals of near 70%, meaning that up to 30% infected people will have a negative test.  Results are influenced by timing and technique.  Test too early, and the confidence intervals can drop below 40%.  A negative test does not mean you cannot spread disease, and a positive test does not mean you will spread the disease.  Using test results to control social, educational, and business interactions will fail to stop the spread of the virus.  Relying on test results to determine who is sick and who is not is dangerous.

So why the push for testing?  Two reasons.  It’s a boondoggle, and it perpetuates the emergency. 

“Free tests” for all Americans are not really free to all Americans.  The government buys them with taxpayer dollars from companies that have little incentive to produce quality tests.  This is because the tests are available by EUA which eliminates the manufacturer’s liability.  There is no consumer protection for shoddy work, no matter how egregious.  Even more, these companies have a governmental market guarantee.  With the promise of four free tests per address, manufacturing test kits is the same as printing money.

But even worse is how indiscriminate testing adds to pandemic panic.  Every positive test raises the CDC’s case count, and rising cases fuel the pandemic, keeping the emergency active.  It should be clear to everyone that the emergency is over.  We have treatments, we have ventilators, we have vaccines, we have hospital beds.  The original emergency was two weeks to flatten the curve.  We’ve reached a status quo.  We may not like where we are, but here we are anyway.  It is no longer an emergency.

It is time we take down our emergency provisions and restore power to the people.  Stop obsessing, stop naming, stop testing indiscriminately.  Everyone knows when they are well and when they are under the weather.  It is time to use common sense about our new common cold.

We know what to do when we have cold symptoms.  Stay home from work, stay away from vulnerable family and friends, and take the vitamins and therapeutics recommended by Front-Line doctors.  Go to the emergency room if you have trouble breathing, if you do not get better, or if something feels different than a common cold.  

Fight corruption and help end the pandemic.  Test as directed by your doctor, not by your government.

Categories
2021 COVID-19 Testing

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, 2021

See 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.

Categories
2021 COVID-19 Science Testing Vaccine

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?

Categories
2021 COVID-19 Science Testing Vaccine

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.

Categories
2021 COVID-19 Testing Vaccine

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:

VaccineLowHighAverage
Moderna8.49.18.7
Pfizer4.27.66.2
Janssen1.43.92.6

Clearly, Moderna vaccine stimulates the highest antibody response.  Then we graphed the antibody response caused by vaccine compared to the immune response of infection.

Chart, box and whisker chart

Description automatically generated

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 SourceLowHighAverage
Pfizer or Janssen1.47.66.2
COVID1.28.44.3

Graphically, the data looks like this:

Chart, box and whisker chart

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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.

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2021 COVID-19 Science Testing Vaccine

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:

IndividualsLowHighAverage
Vaccine171.49.16.6
COVID81.28.34.2

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.