An Observation about the FDA briefing document

Pfizer-BioNTech Vaccine Kids 5 to 11

I have one observation about the FDA Pfizer document.

In the FDA briefing document on Pfizer vax for kids 5 to 11, the strongest argument in favor of authorization is this one: [Paragraph separation mine]

FDA conducted a quantitative benefit-risk analysis to evaluate predicted numbers of symptomatic COVID-19 cases, hospitalizations, ICU admissions, and deaths that would be prevented per million fully vaccinated children 5-11 years of age over a 6-month period, as compared with predicted numbers of vaccine-associated excess myocarditis cases, hospitalizations, ICU admissions and deaths per million fully vaccinated children 5-11 years of age.

The model conservatively assumed that the risk of myocarditis/pericarditis associated with the 10 µg dose in children 5-11 years of age would the same as the estimated risk associated with the 30 µg dose in adolescents 12-15 years of age from Optum healthcare claims data.

While benefits of vaccination were highly dependent on COVID-19 incidence, the overall analysis predicted that the numbers of clinically significant COVID-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases over a range of assumptions for COVID-19 incidence.

At the lowest evaluated COVID-19 incidence (corresponding to the June 2021 nadir), the predicted number of vaccine-associated myocarditis cases was greater than the predicted number of COVID-19 hospitalizations prevented for males and for both sexes combined.

Let’s enumerate the terms of the model

            Term 1:  The probability a kid 5 to 11 will get COVID19 (at different time points)

            Term 2:  The probability a kid who got COVID19 is hospitalized

            Term 3:  The probability a kid who gets vaccine gets myocarditis

Now consider the results of the trial…