Pfizer Push For COVID Vaccine EUA In Ages 5-11 Includes School, Mental Health Arguments
Briefing documents for the upcoming advisory committee tout potential ‘indirect’ benefits and argue that lower dose should address myocarditis concerns.
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Often data was not available from FDA, CDC or the sponsor to answer subgroup, safety and other questions that could have influenced the outcome of the advisory committee meeting.
Many of US FDA's outside vaccine advisors wanted to wait for more data before widespread inoculations of kids 5-11, but felt some high-risk populations should get access to vaccine right away. They urged CDC to provide additional guidance on which children should be targeted.
For males 16-17 years old, excess cases of myocarditis/pericarditis from Comirnaty would exceed COVID-19 hospitalizations and deaths under ‘worst case’ scenario modeled by US FDA; agency nevertheless deemed approval warranted in this subpopulation, citing prevention of nonhospitalized COVID cases and public health benefits from vaccination.