Category: 2021

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2021 COVID-19

Quick Chart on Covid Mortality

This chart on Covid mortality provides perspective during the current spread of the delta variant.  The CDC COVID Data Tracker shows weekly rates per 100,000 population for COVID-19 cases (CDC’s term for infections) and deaths since the outbreak of the pandemic.  Selecting the dates corresponding to the peak death rate for each viral surge in the United States, I divided deaths by cases to approximate risk by age group:

While neither a comprehensive statistical analysis nor an entirely accurate calculation, this chart gives an idea of relative risk at important points in the pandemic.  The delta wave has not peaked, so we may have not seen the highest death rates from the present surge.  The risk of death for the elderly is consistently higher than for younger individuals, and, with few exceptions, age adjusted death rates have decreased in successive waves of the virus.  Maximizing survival should be our objective as the pandemic continues.

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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.

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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 strategically, wrong temporally, and wrong ethically.  There is nothing about FDA approval of vaccine that changes my opinion on this.  Ethical physicians have a duty to speak out on issues affecting patient safety, even and especially during a pandemic.  

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

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

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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.

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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.

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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?

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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 Pfizer, Moderna, Janssen), including the warning that “additional adverse reactions, some of which may be serious, may become apparent with more widespread use”.  We must continue to expect unknown consequences.

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