Pfizer AdComm Asks Many Questions About COVID Vaccine For Ages 5-11, But Gets Few Answers
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.
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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.
Overall benefit still favorable when there could be excess hospitalizations due to vaccine-related myocarditis because of ‘the different clinical implications of hospitalization for COVID-19,’ FDA concludes ahead of the advisory committee.
Briefing documents for the upcoming advisory committee tout potential ‘indirect’ benefits and argue that lower dose should address myocarditis concerns.