Categories
2021 Ethics Vaccine

What FDA Pfizer Approval Means

Today, the FDA approved the Pfizer COVID vaccine.  This vaccine is the first of the three vaccines authorized under EUA to achieve this status.  In this blog, I’ll highlight what this approval means.  Obviously, this is just a first look at the information released by the FDA today.  I’ve not studied the Full Prescribing Information in detail.  There may be more changes that I have overlooked; I will update you on these as they become apparent.    

First, let’s talk about what hasn’t changed.  

  • The vaccine has not changed.  There have been no modifications to the vaccine.  The vaccine that was injected before approval is the same as the vaccine given after approval.
  • The warnings on the vaccine label have not changed.  The Highlights of Prescribing Information issued with the vaccine approval have the same warnings that were listed for the pre-approval vaccine.  These include acute allergic reactions (anaphylaxis), myocarditis and pericarditis, syncope (fainting), altered Immunocompetence, and limitation of effectiveness.  Furthermore, Pfizer does not assure the safety of the vaccine in pregnancy or breast-feeding mothers.  
  • Vaccine experience is still limited.  Although Pfizer updated its clinical trial data to include many more patients, and has expanded the observation period over more time, there are still no long-term clinical trials to study potential adverse effects this vaccine may have three, five, or ten years down the road.  

So far, not much difference.  What has changed?

  • The vaccine is now called “COMIRNATY”.  If anyone understands why they chose this name, please let me know. It’s not obvious to me.  
  • Approval does not include 12-15 year-olds.  On May 10, the EUA for Pfizer vaccination was amended to include children down to 12 years of age.  This vaccine is now approved for individuals 16 years and older.  Children aged 12-15 may still receive the vaccination under a new reissued EUA.
  • Removal of statement warning of unknown future risks.  The previous Fact Sheet for Healthcare Providersincluded the following statement: “Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.”  This statement is not present in the Highlights of Prescribing Information issued with this approval.  However, the Fact Sheet for Recipients and Caregivers still contains the following statement: “These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.”
  • The Pfizer COVID Vaccine is no longer “unapproved”.  This may not seem like much of a substantiative change, but the psychologic and motivational effect of this change will likely be significant.  Those advocating vaccine resistance relished referring to COVID Vaccines as “experimental” because, technically, they were.  Janssen and Moderna still are.  You can’t call the Pfizer COVID vaccine “experimental” anymore because, technically, it’s not.  This semantic change will embolden governments and employers to pursue vaccine mandates.

But this brings us to a few more things that haven’t changed.  I have argued that vaccine mandates are wrong strategicallywrong temporally, and wrong ethically.  There is nothing about FDA approval of vaccine that changes my opinion on this.  Ethical physicians have a duty to speak out on issues affecting patient safety, even and especially during a pandemic.  

The FDA can and has made mistakes in its approval process before.  It will again.  It may have in this instance; time will tell.  But if the FDA has bowed to political pressure to short-circuit this approval, the long-term consequences will be deadly.  Not just to the health and wellbeing of vaccine recipients, but also to the trust that is the cornerstone of America’s healthcare quality. 

According to the AMA Code of Ethics, individuals must participate in their personal healthcare decisions through the process of informed consent  which requires complete, clear, and honest disclosures of all known and potential risks and benefits.  Approved vaccines are not exempted from this moral obligation.  An article published recently in American Journal of Law & Medicine, states that “to be autonomous, decisions need to be based on full, accessible information and reached without coercion.”  No matter how well intentioned, coercion by government or employer cannot be part of informed consent process.  Not in the Land of the Free.  Not in the Home of the Brave.

Categories
2021 Ethics Vaccine

Vaccine Mandates Are Wrong

I’ve argued that vaccine mandates are the wrong objective at the wrong time.  In this article, I want to convince you that vaccine mandates are just plain wrong.  Wrong—as in the opposite of right.  That kind of wrong.

Wait, you say.  The name of the website is BetterPathology.com.  What gives a simple practitioner of pathology the right to lecture us on right and wrong?

Medical ethics is part of every physician’s education and training.  There are gray areas to be sure, but there are also bright lines that separate ethical from unethical practice, and every doctor knows where these lines are.  Every physician knows the elements of informed consent, and every doctor understands why the Tuskegee experiments were wrong.  There are aspects of vaccine mandates that should be troubling to all ethical physicians and all ethical Americans.

To the extent they are able, patients must participate in medical decisions.  Informed consent requires a doctor to explain in understandable language the risks and benefits of a recommended treatment, the risks and benefits of alternative treatments, and the risks and benefits of doing nothing.  It’s one thing to recommend the risks of a therapy when a patient’s natural disease leaves no other options.  It’s quite another thing to recommend a vaccine when the most significant consequence of refusal is job loss.  Threatening a young person to accept the risks of vaccine against his will smacks of Don Corleone’s “offer he can’t refuse.”  Coerced consent is unethical.

Once we lose the freedom to evaluate and choose risks for ourselves, we lose the liberties at the foundation of our nation.  When vaccines are mandated by a government or an employer, the right to choose what we want to put in our bodies is taken away from us.  When we lose this liberty, how long until we also lose the freedom to associate with those we wish, to worship as we please, to speak our minds, or to choose which path we wish for our lives? 

Vaccine mandates stigmatize dissent and erode individual liberty, separating society into vaccinated people and unvaccinated people.  The vaccinated will have freedoms while the unvaccinated will be denied freedoms.  Vaccinated individuals will have the freedom to eat at any lunch counter; unvaccinated folk will be seated outside in the back.  The vaccinated will be able to watch the ballgame from box seats; the unvaccinated will be forced into designated sections in the outfield.  There will be separate water fountains for vaccinated people and unvaccinated people.  There will be separate entrances into public establishments.  Vaccinated people will have unlimited job opportunities while the unvaccinated will find employment prospects limited.  The vaccinated will enjoy unrestricted travel in the mode and style of their choosing; the unvaccinated will have to ride in the back of the bus, partitioned by a plexiglass shield.  Ethical Americans, like ethical physicians, know the immorality of this type of irrational segregation which is based on the false premise that only the unvaccinated can make others sick.  

There have been some ugly chapters in our history.  Let’s not write a new one.

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 Vaccine

Common Sense

As SARS-CoV-2 infections are increasing and some parts of the country are experiencing their highest rates of the pandemic, we face a medical shortage.  In Texas, the supply of staffed hospital beds is shrinking, and some communities are out of ICU beds.  Staffing shortages are becoming critical.  Is this the time to fire doctors, nurses, and other healthcare professionals for refusing a COVID vaccine?

Many people feel sick after a COVID vaccination, and some of those people won’t be able to come to work.  The Janssen vaccine isn’t fully effective for two weeks after the shot.  It takes five weeks for Pfizer and six for Moderna.   Meanwhile, hospitals are short on beds, and even shorter on staff.  Which will save more lives—fully vaccinated healthcare workers or staffed hospital beds?

The healthcare community has managed COVID surges without vaccine before, and we can do it again.  The universal vaccination of healthcare workers achieves no benefit that justifies the violation of individual liberty required to achieve this goal.  You may disagree with me.  We should have that debate.

But right now, those of us who work at hospitals have our hands full taking care of COVID patients.  Can we talk about this later?

Categories
2021 COVID-19 Statistics Vaccine

Updates, Questions, Present, and Future

A lot changed in pandemic landscape last week.  This blog outlines those changes and highlights important unanswered questions.

  • The surge of delta virus infections continues across the country.  Several weeks ago, I announced that the pandemic is over.  That statement requires revision.  Maybe the pandemic of alpha virus was over then, but the epidemic of delta virus is here now.  Delta virus is the overwhelming variant in the U.S. with parts of the country (Florida, Hawaii, and Louisiana) experiencing their highest cases of the entire pandemic.  
  • Deaths are up, but still low.  Unfortunately, it’s no longer the case that deaths are at the lowest level of the pandemic.  Deaths have increased with the current surge of delta virus.  Although even one death is too many, it is reassuring to see that deaths are not at levels seen during the winter surge, and that deaths have increased at a lower rate than infections during the current surge.  As with the previous two surges, older individuals are at great risk than younger individuals.  Based on data from the CDC COVID Data Tracker, COVID-19 deaths per ten million Americans during the week of July 24, 2021, were:  
    • 2 for individuals between 18 and 29 years-old
    • 5 for individuals between 30 and 39 years-old
    • 14 for individuals between 40 and 49 years-old
    • 22 for individuals between 50 and 64 years-old
    • 39 for individuals between 65 and 74 years-old
    • 101 for individuals aged 75 years and older.
  • New testing recommendations for COVID vaccinated individuals.  The CDC has changed its testing recommendations for vaccinated individuals who have had an exposure to someone with SARS-CoV-2 infection.  An exposure is still defined as contact of less than 6 feet for more than 15 minutes when one or both individuals are not wearing a mask.  Before this change, COVID vaccinated individuals were asked to test only if symptoms developed.  Now a SARS-CoV-2 test is recommended for COVID vaccinated individuals 3 to 5 days after the exposure, and the exposed individual should wear a mask indoors for up to 14 days until a negative result is obtained.

As individuals decide how to mitigate personal risk of death from COVID-19, the following information on the CDC COVID Data Tracker would help people make better decisions:

  • Reinfection rates and deaths among previously infected individuals.  Contrary to CDC recommendations, I believe vaccination of COVID survivors is a risk without benefit.  We could know the answer for sure if cases and deaths in the CDC COVID Data Tracker were stratified by previous infection status.  If unvaccinated people with previous infections have low infection and death rates, we could conclude that previous infection provides protection from COVID-19. 
  • Infection rates and deaths among previously vaccinated individuals.  This data exists, but not on the CDC COVID Data Tracker.   We could have a better understanding of the risk of breakthrough and serious disease if the CDC compiled and published this information beside the other important and helpful information on its website.
  • Vaccination complication rates by age and severity.  This information is essential to a risk/benefit analysis of COVID vaccination, but this data is especially difficult to compile for several reasons.  First, not all adverse effects report on VAERS are truly vaccine related.  Second, not all vaccine related adverse effects are reported on VAERS.  Finally, not all adverse effects caused by vaccine are recognized as such.  Delayed effects may never be flagged as vaccine related.  It may take years to ever sort out this problem.  The best we can do now is look at the vaccine warnings (see PfizerModernaJanssen), including the warning that “additional adverse reactions, some of which may be serious, may become apparent with more widespread use”.  We must continue to expect unknown consequences.

We are in our second year of the pandemic, and we have some experience to help us understand what’s coming.  The U.S. is experiencing its third surge of SARS-CoV-2 infections.  The first surge was associated with the original form of the virus.  The second surge coincided with the replacement of the original form by alpha variant.  The current surge began as the wave of delta variant replaced alpha.  Will it be the case that a surge will be experienced time a more infectious variant replaces its predecessor?  Could be.

Categories
2021 COVID-19 Vaccine

Staying Alive

If anything is sacred, the human body is sacred.

― Walt Whitman

How should we define victory in the war on the pandemic?  My vision may surprise you.  I think our objective should be not dying.  Death rates should be our success metric, and the preservation of our institutions and freedoms our goal.  We can accomplish this by making smart individual decisions, not sweeping collective ones.  We cannot allow our society to be fractured into camps of the vaccinated and unvaccinated.

The universal vaccination mandates sweeping across our nation now are more dangerous than the current wave of SARS-CoV-2 infections.  Don’t believe me?  Check out the CDC’s COVID Data Tracker.  Deaths from COVID-19 are at their lowest levels since the pandemic began.  Yet on pain of job loss, we are pushing vaccines into the arms of our young who have the most to lose and least to gain.

Don’t get me wrong.  Vaccination is an important tool in our effort to save people from dying of COVID-19.  Those at greatest risk—the old, the obese, the diabetics—should strongly consider vaccination for their own safety.  Vaccines also reduce the spread of COVID-19 within a community.  When vaccines became available in late December, community infection rates declined as vaccination rates went up.  But that doesn’t mean that vaccination is in the best interest of every individual.

Wait, I hear you say, we must vaccinate everybody to contain breakthrough and stop the spread of the virus.  Especially hospital workers—I want to know that people taking care of me are vaccinated so they won’t make me sick.  Nice theory, but where’s the data that supports the idea that vaccinated people can’t make you sick, that vaccines contain breakthrough and stop the spread of the disease?  I’ve looked; I can’t find it.  If you have it, please share it with me.

I see data that supports the opposite theory.  In last Friday’s Morbidity and Mortality Weekly Report (MMWR), the CDC reported a SARS-CoV-2 outbreak in a highly vaccinated community.  Some were shocked to learn that three-quarters of these cases occurred in fully vaccinated individuals, that the viral loads between vaccinated and unvaccinated individuals were identical, and that four out of five patients sick enough to be hospitalized were fully vaccinated.  This report supports one of the points made last week: vaccination doesn’t prevent COVID-19.  Breakthrough cases occur, and the vaccinated can spread the virus.  Universal vaccination will fail as a containment strategy.

But, you persist, we have to vaccinate everybody before new variants emerge that will be even more dangerous.  After all, you say, 90% of the virus in the reported outbreak were delta variant.  True, this outbreak was mostly delta variant, but delta variant is now the dominant variant in the U. S. because of its higher transmissibility, just like alpha variant replaced original SARS-CoV-2 earlier in the year.  Where is the evidence that universal vaccination prevents formation of more dangerous variants?  Again, I’ve looked, and I don’t find it.  If you have it, please share it with me.

Infectious disease orthodoxy says the opposite.  Indiscriminate use of anti-biologic agents pressure pathogens to mutate, increasing their virulence.  Doctors are reprimanded for treating viral illnesses with antibacterial agents (“antibiotics”) because they have potential for more harm than good.  The same is true for vaccines designed to prevent infections by viruses that easily mutate. That’s one reason we don’t have vaccines for the common cold—the target moves too quickly, and infection is not that dangerous to most people.  Universal vaccination will fail to prevent emergence of variants.

If universal vaccination becomes our objective in the war against the pandemic, deaths may increase, surges may continue, and more dangerous variants may emerge, but won’t we feel good about our vaccination rates?  The pandemic has an enemy; it’s not the unvaccinated.

There is another way.  Allow doctors to make individualized decisions for treatment and vaccination in the best interest of each patient.  If we do all we can to help those at risk, deaths will continue to go down.  The virus may never go away, but we can learn to live with it.  We can also preserve our institutions and freedoms, and we can stop dividing people.  We can stay alive.

Categories
2021 COVID-19 Science Vaccine

A Pandemic of the Unvaccinated?

During a White House press briefing last week, Dr. Rochelle Walensky, the director of the CDC, declared, “This is becoming a pandemic of the unvaccinated.”  She continued, “And our biggest concern is that we are going to continue to see preventable cases, hospitalizations, and, sadly, deaths among the unvaccinated.”  Is there a rational basis to allow our war against the pandemic to devolve into a fight between vaccinated and unvaccinated citizens?  In this blog, I will use data found at the CDC’s website to outline what we know and what we don’t about vaccinations, infections, disease, and death.

What we know:

  • SARS-CoV-2 infections have increased recently.  It’s easy to see this point from the CDC’s COVID Data Tracker.  Play with the graph a little.  By clicking any of the boxes (sex, age, ethnicity) under “Cases” on the upper left, you’ll see case trends of the entire pandemic.  Pass your cursor along the horizontal axis, and you’ll see the rate of cases each week of the pandemic.  The number of cases bumped up in the first two weeks of July.  But the recent increase is not yet close to levels of the surge last winter.   
  • Deaths from COVID-19 are still going down.  Using the same graph, click on any of the boxes under “Deaths” on the upper right.  The last week deaths increased was May 8, and then only by a little bit.  There has not been a spike in COVID deaths since the winter surge.  Even as infections increased recently, deaths have not.
  • Risk of death from COVID-19 increases with age.  Now look specifically at deaths by age.  Move your cursor along the horizontal axis and pay attention to the death rate as age increases.  It’s the old who die from COVID-19, not the young.   
  • Vaccination rates are highest among those at greatest risk of death from COVID-19.  Now study another chart from the CDC’s COVID Data Tracker.  Notice that in increasing age groups, more and more people are at least partially vaccinated, more than 90% among 65–74 year-olds.  The old, who have the greatest risk of death from COVID-19, also have the highest vaccination rates.  
  • Vaccination does not prevent COVID-19.  Breakthrough cases occur, and vaccinated individuals can spread the disease.  This last point is well known by everyone who follows Texas politics.
  • Community vaccination rates correlate with reduction in COVID-19 spread.  For this point, study the CDC’s vaccination vs. covid heat map, showing lower rates of COVID-19 where vaccination rates are higher and vice versa.  This is the data Dr. Walensky points to when saying “This is becoming a pandemic of the unvaccinated.”  However, unless she has private data not on the website, I do not see a similar correlation between deaths or even hospitalizations.  Death rates continue to decline, even among the unvaccinated.

There are some things we don’t know, and we don’t know them because we don’t yet have good data.  For example, the CDC tracks COVID-19 deaths by sex, age, and ethnicity, but not by vaccination status.  That information would be very helpful to individuals deciding whether to take a vaccine.  So would age-adjusted vaccine complication rates.  The absence of such data makes it difficult-to-impossible for young people to determine their personal risk-benefit ratios for vaccination.  The VAERS website is good for its intended purpose as a reporting site for adverse events, but the data must be mined and analyzed to be meaningful.  

Good data is simply hard to come by.  Last week, Sir Patrick Vallance said in a press conference that 60% of hospitalized COVID-19 patients in the UK are fully vaccinated.  Later, he tweeted a correction, saying exactly the opposite.  The trouble is that it’s impossible to validate either statement with reliable, publicly available data.  

Science is a process, not a product.  For science to work, conventional wisdom must be questioned.  It is always okay to ask, “Why should I believe this?”  Dissent is a natural byproduct of science.  But dogmatism, coercion, ridicule, hyperbole, and fearmongering have no place among real scientists.  Not even the director of the CDC.

Categories
2021 COVID-19 Vaccine

A New Vaccine Warning: Guillain-Barré Syndrome

Last week, the FDA added a new statement to the Janssen vaccine Factsheet for Healthcare Providers, warning of an increased incidence of Guillain-Barré Syndrome among vaccine recipients. This warning was issued after cases in India and the United Kingdom were published in the Annals of Neurology.  Although the warning only applies to the Janssen vaccine, at least one case has also been reported following Pfizer vaccination.

Guillain-Barré Syndrome is a condition in which the immune system attacks peripheral nerves, the nerves responsible for sending signals for motion and sensation between the body and the brain, resulting in pain and weakness, and in severe cases, paralysis and death.  Although most people recover, symptoms may linger for a long time.  Guillain-Barré Syndrome is triggered by various conditions that cause inflammation, including infection, surgery, trauma, and cancer.  Rarely influenza and childhood vaccines have been associated with Guillain-Barré Syndrome.

Guillain-Barré Syndrome was identified as a complication of COVID-19 early in the pandemic.  Subsequent studies demonstrate that these cases are “not due to a direct attack of the virus, but rather to an immunological reaction to the virus.”  Now we learn this long-recognized complication of COVID-19 can also be an adverse effect of a COVID vaccine.

The warning for Guillain-Barré Syndrome is the third FDA statement of an immune mediated vaccine complication, adding to the precautions previously issued for myocarditis and clotting disorders.  Interestingly, myocarditis and clotting disorders have also been recognized as complications of COVID-19. 

It’s becoming increasingly clear that COVID-19 has two separate disease pathways.  The first is the direct effect of the virus.  The second is the response of our immune system to the virus.  Vaccines intentionally stimulate this immune response.  Is it surprising that adverse vaccine effects overlap with COVID-19?  Expect more examples of autoimmune complications of COVID vaccines.

Categories
2021 COVID-19 Vaccine

COVID and Autoimmune Disease

Some individuals infected by SARS-CoV-2 experience brain damage.  Although it sounds like science fiction, “COVID brain fog” describes a very real condition in which infected patients experience memory loss, strokes, and other nervous system lesions.  How can this happen?

In an article published last week in Nature, Michael Marshall, a free-lance science journalist from the U.K., describes the current areas of research into the causes of this condition.  One possible mechanism is autoimmune disease.

The immune system’s job is to protect the body from agents of disease (“pathogens”) without damaging the body’s own cells.  Like the military guarding the border of a sovereign nation, the constituents of the immune system carry lethal weapons meant to destroy an invading enemy.  But what if the military can’t tell the difference between friend and foe?  Those lethal weapons might be unleashed on its own people, and the citizens of that nation would be at risk of harm from their own government.  Let’s say for example that the U.S. learned all its enemies wear red hats.  If the army was ordered to seek and destroy anyone wearing a red hat, many innocent Americans unwittingly wearing red hats could be killed in an effect to stamp out a threat to our nation.  

The immune system works by learning something about the pathogens that threaten the body—not the color hats they wear, but the shape and composition of molecules on the invaders.  When the shape and composition of those molecules are similar enough to the shape and composition of molecules on the cells in our own body, the immune system can’t tell the difference, and it attacks us.  That’s autoimmune disease.

Autoimmune disease is highly individualized.  Although we lump these diseases into categories ranging from lupus to rheumatoid arthritis, each person with an autoimmune disease has a disease that’s uniquely his or her own.  There’s a lot of overlap, but no two individuals have exactly the same disease manifestations.  

There are many examples of autoimmune disease targeting specific organs.  Hashimoto’s thyroiditis is a disease in which the immune system targets the thyroid gland.  In Crohn’s disease the immune system targets the cells of the gastrointestinal tract.  Multiple sclerosis is an autoimmune disease of the central nervous system.   COVID brain fog may also be, at least in part, an autoimmune disease of the central nervous system in which an immune system primed to destroy SARS-CoV-2 causes collateral damage to the brain.

If that’s the case, we have yet another reason to avoid COVID-19.  But we may also want to avoid stimulating the immune system to fight SARS-CoV-2, which is precisely the goal of a COVID vaccination.  We know that everyone who has had COVID-19 develops antibodies to the viral spike protein.  We also know that everyone who has received a COVID vaccine develops antibodies to the same viral spike protein.  What if these are the autoantibodies associated with COVID brain fog?

Although there is no proof this is the case, there is evidence suggesting that the idea is plausible.  Last week, we learned that vaccines may cause myocarditis and pericarditis, essentially an autoimmune disease affecting the heart.  VITT, a condition in which vaccination causes blood clots, is also immune mediated.  We must consider the possibility that stimulation of immunity against viral spike proteins causes autoimmune disease in some vaccine recipients.

As we connect more dots, an image emerges from the haze of the pandemic.  As the picture becomes clearer, will we have the courage to believe what we see?

Categories
2021 Science Vaccine

More Vaccine Complications

We have warned of the dangers of unforeseen consequences inherent in medical therapies and procedures that have not been thoroughly tested.  All COVID vaccines are in this category since they are only available in the U.S. are under Emergency Use Authorization.  None has been approved by the FDA.  

Information about vaccine complications is slowly emerging.  First, we learned of the 10x higher incidence of anaphylaxis from mRNA vaccines compared to other vaccine types.  Then we learned of a new clotting disorder caused by vaccine called VITT.   Last week, the FDA required a new statement in Pfizer and Moderna Factsheets for Healthcare Providers warning that certain cardiac disorders, including myocarditis and pericarditis, may be caused by mRNA vaccines.  

In the pathology world, adding “-itis” to the end of a word simply means inflammation.  So, myocarditis is inflammation of muscle (“myo-”) of the heart (“card”), and pericarditis is inflammation of the sac around (“peri-”) the heart.  By themselves these words are vague and do not say what that inflammation means to a person.  Myocarditis can be mild and go away on its own, or it can be severe and cause the heart to stop beating.  Similarly, mild pericarditis is a common finding in many disease processes, but pericarditis can become so severe that it restricts the movement of the heart, a condition called “cardiac tamponade” which can be deadly. 

These vaccine complications tend to occur in young people who receive mRNA vaccines (Pfizer and Moderna, but not Janssen), especially when there is an underlying cardiac condition.  The trouble is that this vaccine complication may be the first sign of an underlying cardiac condition, since “in this younger population, coronary events are less likely to be a source of these symptoms.”  Does this make the vaccine unsafe for adolescents and young adults?  The CDC says no; I’m not so sure.  

It’s noteworthy that none of these complications—not anaphylaxis, not VITT, and not inflammatory heart conditions—were included in data submitted to FDA for initial authorization.  We are learning as we go. Quite literally, if you take a COVID vaccine, you are part of a study of the long-term effects of that vaccine on humans.  There may be compelling reasons for a person to take a vaccine, ranging from personal health benefits to scientific altruism.  But just as compelling may be the reasons a person chooses not to take a vaccine.  We should not coerce these decisions, we should not ridicule these decisions, and we should not penalize individuals for these decisions.  

We simply don’t know all the long-term consequences of the COVID vaccines.  But if history is any guide, there will be unintended consequences that may make the “smart people” of today look foolish in the future.