Category: Vaccine

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2021 COVID-19 Science Vaccine

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.

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2021 Ethics Science Vaccine

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.

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2021 COVID-19 Vaccine

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.

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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?

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2021 COVID-19 Ethics Science Vaccine

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.

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2021 COVID-19 Science Vaccine

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.

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2021 COVID-19 Vaccine

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. 

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2021 COVID-19 Vaccine

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.

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2021 Vaccine

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.

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2021 Vaccine

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.