Although they were aware of this safety signal, theFDA issued the EUAon May 10 for Pfizer’s mRNA vaccine in kids ages 12 to 15. Despite the fact that the vaccine was already widely in use in people ages 16 and above under the existing EUA, specific rates of myocarditis in the U.S. for ‘near age’ vaccine recipients (kids ages 16 to 18) were not made publicly available. In other words, no data on myocarditis events in kids close in age to the group receiving the new EUA (those ages 12 to 15) were leveraged in the process for granting this EUA. This is unfortunate, as these data would have had the greatest relevance and implications for the adjacent-age group.
The CDC acknowledged more cases in young people than older people, more cases in young males than young females, and higher incidence after dose two than dose one. The absolute risk of myocarditis after the second dose based on the number of CDC confirmed cases would be one in 15,000 to 20,000 for boys ages 12 to 24. There is a smaller but still excess risk in women age 24 and younger.
At its meeting, ACIP considered figures and data, which claimed to weigh the benefits versus harms of “dose two” of mRNA vaccines in this age group. However, in reality, the scenarios presented by the CDC compared the risks versus benefits to young people of no vaccination at all versus a scenario in which they received both shots.
The CDC did not consider the harms versus benefits of one versus two doses, but only the harms versus benefits of vaccination itself. But the CDC went beyond this. They also used base rates of infection from the past, rather than current rates of SARS-CoV-2 spread, which are substantially lower. They did not differentiate between healthy kids — who are at risk of idiosyncratic events, such as myocarditis — and kids with pre-existing medical conditions that place them at high risk of severe outcomes from COVID-19, including hospitalization.
This insistence on an all-or-nothing, one-size-fits-all binary approach — treating healthy kids who have recovered from confirmed prior infection as equivalent to infection-naive kids with comorbidities — is at the heart of the fallacy underpinning ACIP’s decision.
Immediately after the ACIP meeting, various agencies and professional societies released ajoint statementarguing that the benefit of vaccination far outweighs the risk in all age groups and demographics. Yet, our analysis suggests this is a premature conclusion. It relies on models that use outdated COVID-19 risk rates — the on-the-ground rates in the moment are far lower, shifting the harm/benefit calculus to harm. It assumes two doses or none at all are the only options. It does not tailor recommendations by sex, natural immunity, or even comorbidities. We acknowledge there are individual and community level benefits to vaccination that extend beyond preventing hospitalizations and are an important part of the discussion. But these omissions from ACIP/CDC are problematic.
A primary care physician by training, my passion is researching and writing about maintaining patient-directed choice in medical care, supporting independent physicians, promoting free-market healthcare solutions and seeking sustainable fiscal policy in healthcare.
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