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…