Doctor warns it’s ‘too soon’ to require COVID shots for kids

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[Editor’s note: This story originally was published by Real Clear Science.]

By Buzz Hollander, M.D.
Real Clear Science

The Vaccines and Related Biological Products Advisory Committee met yesterday (10/26/21) to discuss recommending an Emergency Use Authorization for the Pfizer vaccine against Covid-19 in children ages 5 to 11. The panel voted 17-0 in favor.

The second largest school system in the United States, the Los Angeles Unified School District, has already required all students 12 and older to be fully vaccinated against Covid-19 in order to attend in-person school, barring a physician-certified medical exemption. The State of California has expressed that it will follow suit in mandating vaccination for Covid-19, albeit likely not until 2022, awaiting full FDA approvals for the vaccines.

The national debate on this subject already has been intense, and it will grow in volume in the weeks and months to come. In many ways, we have never seen a vaccine quite like these mRNA vaccines for Covid-19. Politically and ideologically, they enter the fray of school mandates in a uniquely charged environment.

There is a long history of school vaccine mandates in our country. However, the Pfizer vaccine and the disease it prevents have certain novel aspects that do not fit smoothly into that history. Given what we know about the mRNA vaccines and Covid-19, I find it unwise and unreasonable to include them as a required immunization in our schools.

      What Does It Take to Mandate a Vaccine?

Common sense dictates that the more confidence we have in the safety and efficacy of a vaccine, or its ability to lead to herd immunity; and the more severe the consequences of the disease are for both individuals and society; then the more reasonably we can require it among schoolchildren. Put more explicitly by the UK’s independent Nuffield Council on Bioethics:

“When assessing whether more directive policies are acceptable, the following factors should be taken into account: the risks associated with the vaccination and with the disease itself, and the seriousness of the threat of the disease to the population.” And: “We identified two circumstances in which quasi-mandatory vaccination measures are more likely to be justified. First, for highly contagious and serious diseases, for example with characteristics similar to smallpox. Secondly, for disease eradication if the disease is serious and if eradication is within reach.”

So, how does the Pfizer vaccine in regard to children and adolescents fare within this framework?

Children ages 5 to 17 have the lowest mortality and morbidity of any age group; and boys and young men have the highest rate of mRNA vaccine-mediated myocarditis of any demographic. That combination, coupled with real concern that the large proportion of school children already infected by SARS-CoV-2 might have little benefit and substantially higher risk of adverse effects from vaccination, makes this a particularly ill-suited population for which to seek a universal vaccine mandate.

Let’s dig into the details.

      Vaccine-Induced Myocarditis 101

Every vaccine has adverse reactions; and the mRNA vaccines might not be as historically problematic as those arguing against them like to suggest. The smallpox vaccine, for example, was reported by the Department of Defense in 2003 to be triggering post-vaccine myocarditis at a 1 in 1724 clip! For the mRNA vaccines from Pfizer and Moderna, most serious safety concerns, such as thrombotic events, Bell’s Palsy, or Guillain-Barre Syndrome, are in the 1/100,000-1/1,000,000 range. However, we have one glaring problem with the mRNA vaccines: a high rate of post-vaccine myocarditis in young men and adolescent boys.

Myocarditis (inflammation of the heart muscle) and its typically less severe cousin, pericarditis (inflammation of the lining of the heart), are significant health concerns. The chest pain and palpitations that can signal a symptomatic myocarditis case generally lead to a 1-3 day hospitalization, sometimes an ICU stay, and often a warning to avoid strenuous activity for 3-6 months. Even though most accounts of post-vaccine myocarditis imply an uncomplicated course, we await more data from the CDC to evaluate long term outcomes in these cases — myocarditis from an infection or cocaine binge is capable of terrible long-term consequences, ranging from heart failure to sudden death. At this point, since most case series on post-vaccine myocarditis report normal heart function by discharge, there is reason for optimism — but nothing like certainty.

We also lack certainty as to why young men are disproportionately affected, or even why the mRNA Covid-19 vaccines and not the adenovirus vector vaccines cause this particular reaction. No, it is not because the spike proteins encoded by the mRNA are “cytotoxic” to heart muscle. As VRBPAC member, rotavirus vaccine originator, and Infectious Disease physician, Dr Paul Offit, explains to Dr Zubin “ZDogg” Damania, most likely it’s related to the potent immune response triggered by the mRNA vaccines. The fact that the great majority of cases are reported after the second dose argues for this explanation; if it were a matter of millions of spike proteins somehow floating free in the bloodstream, we would expect rates after the first shot to be similar to those after the second.

This raises another concern: if the severity of the second shot is due to a primed immune system, might the risk of the first shot for someone with prior Covid-19 infection mirror that of a second shot for those without? I am unaware of any published studies on this question despite its importance. We do have anecdotal series, like the study on U.S. military members in whom 20 cases of myocarditis occurred after the second mRNA shot, none of whom had prior Covid-19; and 3 occurred after the first shot, all of them in soldiers with prior infection. These findings are intriguing, and concerning, but it’s unsettled science.

Why this phenomenon affects males preferentially over females – most studies report anywhere from 5-20 times greater rates among males – is another mystery. Obviously, male hormones, like testosterone, are suspected to be involved, but there is no consensus on the matter. Whether young boys in the 5-11 age range will have similar myocarditis rates after vaccination might hang in the scientific balance, but we have literally no trial data on the subject beyond the 3000 vaccinated participants in the Pfizer trial for this age group.

What we do have is real world data on the rates of myocarditis in slightly older males after a second mRNA shot from many places:  U.S. civilians (Pfizer: approximately 1/5,000 ages 16-17, 1/5,600 ages 12-15) and military (mRNA <1/10,000 age <20), Ontario, Canada (Pfizer: 1/11,000 ages 12-17, Moderna: 1/3,500 ages 18-24), and Israel (Pfizer: 1/6,600 ages 16-19). The latter study, published in the New England Journal of Medicine, with the benefit of a Health Maintenance Organization able to track each shot given and review case data for every myocarditis claim, offers in my opinion the most reliable numerator and denominator in the published realm for the post-Pfizer myocarditis rate.

How the data is gathered influences the numbers you’ll see bandied about in the media. Combining Pfizer’s vaccine Comirnaty with Moderna’s higher dose Spikevax will skew data unfairly in a discussion of Pfizer mandates, since Moderna’s higher myocarditis rates led to most Scandinavian countries pausing its use in young men. The Israeli studies exclude pericarditis, which tends to be less severe and is more likely to affect older people and women, but Ontario includes it. The CDC’s earlier U.S. data excluded “cases still being reviewed”; while the Ontario raw data includes only reviewed cases, but does not exclude the 25% of cases not conclusively found to be actual myocarditis or pericarditis. So — all these numbers must be taken with a grain of salt; but that 1/6,600 rate for males 16-19 is as solid as we have.

      Expert Misinformation & the Joe and Sanjay Show

What really must be taken with a grain of salt, though, are claims that post-vaccine myocarditis among young men are exceedingly rare. In his chat with ZDogg, Dr Offit variously refers to the rate as 1 in 40,000 or 1 in 45,000. Here, he describes the risk for men 18-39 as a 1 in 50,000 occurrence — in a video entitled, “What should I know about COVID-19 vaccine and myocarditis in teens?” (emphasis mine).

I believe that figure comes from a slide from Dr Hannah Rosenblum’s July 22, 2021 presentation to the CDC’s advisory committee. It lists men ages 18-29 as calculated to have a post-second-mRNA-vaccine myocarditis rate of 24.3 per million, or 1/41,150.  This incidence is about five-fold lower than that which Pfizer presented to the FDA last week. More importantly, as a member of the FDA’s Vaccines and Related Biologic Products Advisory Committee, I expect Dr Offit to have been aware of the plentiful data suggesting a rate among actual teenage males over five times that which he was quoting.

Then we have the argument that the SARS-CoV-2 virus causes more myocarditis than the vaccine anyway – the “why are we even talking about this?” approach. Dr. Sanjay Gupta, whose three hour long interview with Joe Rogan is perhaps the best evidence from the past decade that Americans have not actually lost their attention span, attempted to make this claim. First, he tried to establish the background rate for myocarditis among children pre-pandemic, saying, “per million it’s like 1500.” Granted, I might mix up a few statistics chatting with Joe Rogan and his few million listeners, but this was remarkable. In Finland and South Korea, the background pediatric myocarditis rate was determined to be about 20 per million, and only about 10 per million in the U.S.

Dr Gupta goes on to describe “5.8 per million myocarditis rates” among children after the second shot, correctly recalling Dr Rosenblum’s July 22 figure… for men 30-49 years old. He’s low by a factor of about 25 here for actual adolescent boys.

Finally, Dr Gupta asserts that Covid-19 is “sixteen times” more likely to induce a viral myocarditis in kids than the vaccine, for a rate “maybe just under a hundred out of a million.” The first part of this statement presumably comes from a study finding that people hospitalized with Covid-19 were 16 times more likely to have myocarditis than those hospitalized for other reasons; for kids under 16, the incidence was actually 37 times higher. However, the rate of children admitted to the hospital with Covid-19 who actually had myocarditis was merely 0.133%.

It’s not hard to check the math here. The CDC’s COVID-NET site tells us that children under 18 had a cumulative hospitalization rate during the March 2020 to January 2021 time frame of the study amounting to 295 per million. If 0.133% of them had myocarditis, that’s a little under 0.4 per million, over roughly 10 months of the pandemic. Annualized, that’s about a one in two million incidence of pediatric SARS-CoV-2 myocarditis – versus the 1/6,600 myocarditis rate we would expect within one week of giving teenage boys a second Pfizer shot.

Since 40% of pediatric myocarditis was associated with Covid-19, that would put the rough overall incidence at about 1 per million, an order of magnitude lower than expected from the cited studies on background myocarditis rates. Perhaps this should have been the central point of the study’s final discussion; or an acknowledgment that Covid-19 myocarditis is extremely rare in kids. Instead, the conclusion read:

“On June 23, 2021, the Advisory Committee on Immunization Practices concluded that the benefits of COVID-19 vaccination clearly outweighed the risks for myocarditis after vaccination. The present study supports this recommendation by providing evidence of an elevated risk for myocarditis among persons of all ages with diagnosed COVID-19.”

Truly, I admire Dr Gupta’s affable composure in an impossible situation with Joe Rogan; and Dr Offit’s enviable grasp of vaccinology. However, our public-facing health experts have to do better than this if they are to improve their standing among the vaccine-hesitant. Don’t take my word for it; google “Rogan destroys Gupta” and start scrolling.

      What About the Benefits?

I might be able to pick at the mRNA vaccines on the one point of myocarditis in young men, but it’s easy to celebrate their remarkable efficacy. While studies among those ages 12-15 as well as 5-11 were too small to provide any data on protection against severe disease, they neatly matched adult data against symptomatic infections, with 100% (16 cases in placebo to zero in vaccinated) and 91% (16 cases vs 3) efficacy, respectively.

For some period of time — perhaps 3-6 months, if the lower dose given to children (10 mcg vs 30mcg to those over 11 years of age) leads to similar results as seen for adolescents and adults — vaccinating large groups of children should reduce overall cases and therefore transmission in the overall population. Fewer cases should also lead to fewer cases of “long Covid,” which recent studies suggest might affect a small percentage of childhood infections. Less Covid-19 also means less of the rare but severe Multisystem Inflammatory Syndrome in Children (MIS-C).

However, do these benefits call for a mandated vaccine?

To return to our charge in determining whether to require a childhood vaccine, we are encouraged to ask: is Covid-19 “highly contagious and serious?” Highly contagious, yes. However, with the population in question, Covid-19 would rank low among contagious childhood diseases as far as severity.

The annual pediatric disease burden of influenza is remarkably similar to that of Covid-19, and yet the flu vaccine evades state school mandates. In the 2017-18, 2018-19, and 2019-20 flu seasons, pediatric influenza hospitalization rates among those age 5-17 have averaged 37 per 100,000; the first 12 months of Covid-19 averaged 29 per 100,000 in that age group, and the most recent 12 months, 41 per 100,000. Pediatric flu deaths have averaged 495 per annum over those three years; the total Covid-19 pediatric mortality, including age 18, since March 2020 is 637.

These numbers are not trivial; there is good reason we encourage the influenza vaccine among children every year. However, do these numbers represent a health emergency leading to mandatory flu shots? For some perspective: this 2016 New England Journal of Medicine article listed the ten most common causes of pediatric death; acute respiratory disease did not make the list.

I don’t want to seem callous; as a parent and a physician, I loathe every story of a child suffering, whether it be from mental health issues, a motor vehicle accident, or a respiratory virus. However, I take the Hippocratic oath and its charge to “First do no harm,” seriously.

      Risk:Benefit Mismatches

This is where universal mandates for school children fail: risk from mRNA vaccines falls unevenly on one group (boys and young men, perhaps especially with a history of prior infection), while benefit from vaccines accrues primarily to a different group (high risk children without prior infection).

I do think that the risk of Covid-19 to children (and healthy people in general) has been understated by many who appear to relish devaluing the Covid-19 vaccines or school mitigation measures. Being a healthy child does not equate to being invincible against severe disease; studies vary, but a JAMA Network review found 40-62% of pediatric hospital admissions with Covid-19 reported comorbidities — not 100%.

That said, severe disease does tend to concentrate among children and adolescents with health problems. While approximately 19% of U.S. children are diagnosed with obesity, 35% of those hospitalized with Covid-19 are obese. 7% of U.S. children have asthma, but 15% of pediatric Covid-19 hospitalizations carry that diagnosis. Neurologic and developmental disorders are rare, but constitute 14% of Covid-19 admissions.

Death from Covid-19 among children is relatively rare, as noted previously, but even more strongly tied to existing health issues. Of 112 Covid-19 deaths studied early in the pandemic (PDF), 86% of patients had at least one comorbidity, half had 3 or more, and a quarter had 5 or more.

Assessing the numerical risk of severe Covid-19 to school children is a challenging exercise. COVID-NET informs us that within their U.S. surveillance areas an “average” 5-17 year old had about a 1 in 2500 risk of hospitalization with Covid-19 in the past 12 months. We need to consider that reported Covid-19 hospitalization rates include all patients admitted with a positive Covid-19 test, which a Stanford study found to be unrelated to the admission in 45% of cases. If accurate and broadly applicable, that could drop the chances of Covid-19 actually causing a hospital admission for our average 5-17 year old to around 1/4400. To further complicate matters, not every MIS-C case likely ends up being counted as a pediatric Covid-19 hospitalization by COVID-NET.

These calculations are just for an average risk child, however. A school mandate would require low risk children to be immunized, too.

It’s impossible to say with confidence how far good health moves the needle in childhood hospitalization risk; this communication from my medical school alma mater neatly explains how risk factors for infection can be easily mistaken as risk factors for severe disease. However, if comorbidities affecting about a third of children truly lead to half or even two-thirds of pediatric hospitalizations, healthy kids might have 25-50% the Covid-19 hospitalization risk as those with medical comorbidities.

My point: the annual risk of hospitalization due to Covid-19 for a healthy school age boy even with no prior immunity could conceivably drift down to a level approaching the risk of hospitalization from a second Pfizer vaccination. I have been informed in past months that this is a “fringe” belief, but as of this week Pfizer rather surprisingly admits this possibility in their documents for FDA review! In times of low community prevalence, they state: “the model predicts more excess hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined.”

Then there’s the hotly debated matter of immunity due to prior infection. For a healthy school age boy with confirmed prior SARS-CoV-2 infection, it’s possible the additional protective benefit against severe disease via vaccination approaches zero, while the risk of vaccine-mediated myocarditis might be even higher than our 1/6,000-7,000 average.

      Herd Immunity Is Hard

Returning to our general considerations for vaccine mandates, we might be inclined to pursue them, “if the disease is serious and if eradication is within reach.” Clearly, I question that childhood Covid-19 is “serious” in the way that, say, measles is serious, with a death rate for unimmunized children in the 1 in 500 ballpark. And, sadly, eradication is not within reach for Covid-19.

In long-ago days, I naively believed that we would reach herd immunity for Covid-19 far below the oft-quoted 65% threshold, and we would ride off into a comfortably endemic sunset by Autumn 2020. That didn’t happen. Now, with our highly transmissible delta variant everywhere, and nothing less transmissible ever likely to pass evolutionary muster, we are not going to make SARS-CoV-2 go away, no matter how far-reaching our vaccine program.

It’s simply disingenuous to claim that vaccinating children is an essential weapon in a battle to achieve herd immunity. Singapore is the latest example of an exceptionally well-vaccinated country (84% of all residents fully vaccinated) experiencing a massive wave of cases after trying to return to “normal” life a bit. Even if every single one of the 27-some million children age 5-12 was fully vaccinated next week, our national percentage would still sit around 65%. We simply cannot put a shield around all of our vulnerable Americans with a school vaccine mandate.

      Grading on a Curve

Similarly, after a year and a half of calls to “flatten the curve,” it’s not rational to take the same approach with pediatric Covid-19 vaccination. Pediatric ICUs are built to withstand flu season, which is often concurrent with the Respiratory Syncytial Virus (RSV) season; the latter generally leads to more hospitalizations in young children than either influenza or Covid-19.

Yes, there was stress on some pediatric ICUs this summer during the delta wave in the U.S., some due to the unprecedented summer RSV outbreak. If the goal is to take some pressure off children’s hospitals, however, a massive universal childhood vaccine campaign in southern California next month involving more than a hundred thousand male students is probably not the way to do it.

     The Long Arm of the Law of Unintended Consequences

I am not so insensitive to the voices of my colleagues in Infectious Disease and Pediatrics that I cannot hear them objecting. Loudly. One objection might be, “Why would you give ammunition for vaccine-hesitant parents and kids to avoid a societally-useful, individually-protective vaccine, all over a rare,1/6,600 reaction?” My inner Libertarian has a ready answer for that: I cannot endorse any policy that requires a substantial segment of the population to undergo a medical intervention in which the risk of harm might possibly exceed the benefit. In fact, I feel obliged to fight it.

However, the second objection I imagine is a bit more complex: “Didn’t you get the memo in medical school that we don’t frame immunizations as an individual risk:benefit analysis, because almost no one has a positive risk:benefit ratio when it comes to vaccinating against diseases that vaccines have made so rare that no one gets them?”

I get this one. I haven’t seen a case of measles in a decade or two. The lifelong immunity conveyed by a measles infection, coupled with an extremely effective and lasting vaccine, has almost made it disappear in this country (well, until recently, anyway). An honest risk:benefit discussion would have to mention the highish rate of febrile seizures among the one year olds who get their first MMR shot; and the fact that their risk of getting an actual case of measles is close to zero… if they avoid pockets of unimmunized kids! On an individual level, the calculus might favor no shot. However, if enough parents make the decision to forego an MMR, then predictably we start seeing outbreaks of a disease with that cruel 1/500 mortality rate.

Measles is the poster child for a mandated vaccine: highly contagious, serious, and eradicable. I want to have enough faith in human rationality to think that a mandate should not even be needed for the MMR vaccine. However, if many opt for misguided short-term self-interest when it comes to measles, many will suffer more deeply in the long-term. So, clearly, some vaccine mandates are necessary – backed by both scientific evidence and medical ethics.

The Pfizer vaccine is quite different, however. Vaccinating children provides some reduction, for some amount of time, in the spread of SARS-CoV-2, but not enough to eliminate the threat of Covid-19 in the long-term. Those children who choose to be vaccinated will have excellent, almost perfect, protection against becoming severely ill; those who do not, will still fare well the vast majority of the time, especially if in good health.

We do not need to mandate this vaccine in children. However, Los Angeles has started this ball rolling. The argument so often repeated on behalf of mandating Covid-19 vaccination — “What’s the big deal? We mandate 8 other vaccines for school!” — has gotten folks thinking. Some of them are thinking, perhaps for the first time, “That’s not right to mandate those vaccines, either!”

Ohio Congressman Jim Jordan kicked up a vaccine sandstorm when he recently tweeted, “Ohio should ban all vaccine mandates.” Maybe it will end up only being an impetuous tweet; or maybe it will end up being another exhibit demonstrating the law of unintended consequences. Sometimes, more trouble than good comes out of well-meaning efforts that were not needed in the first place.

     Keeping the Baby, Not the Bathwater

As we watch the process unfold of FDA and CDC meetings over the Pfizer vaccine approval for ages 5-11, conversations about myocarditis and how it affects overall risk calculus will likely feature prominently. Perhaps mitigation approaches will be discussed, like single shot regimens, consideration of immune status, or a delay before the second dose. I don’t think a single relatively rare adverse effect should derail the approval process, given the vaccine’s clear benefit to kids and families at higher risk of severe disease. I would be shocked if it did.

However, I would be thrilled to see language included to discourage universal vaccine requirements for children and adolescents. It will soon be time to start the process of gathering safety data in those children age 5-11, and to gather more data for adolescents age 12-17. It is not the time to require vaccinations in these groups without better understanding their consequences.

International precedent exists. The data creates real uncertainty over personal and societal benefit for universal vaccination. It is Pfizer’s corporate duty to seek the broadest possible implementation of its vaccine, but even its most prominent board member is warning us: it’s too soon to mandate these vaccines to children. Our public health experts need to listen.

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