US FDA Finds Pfizer’s COVID Vaccine For Kids 5-11 Worth The Risk Even In Lowest Incidence Model
Executive Summary
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.
You may also be interested in...
US FDA Tags Moderna COVID-19 Vaccine With Higher Myocarditis Risk Than Pfizer/BioNTech
In expanding authorization of booster doses for both mRNA vaccines, the agency updated Moderna’s fact sheet to state the vaccine appears to pose a higher risk of myocarditis/pericarditis in males under age 40 years after the second dose, although data are ‘not yet dispositive.’
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.
Pfizer COVID Shot: Unanimous Vote Obscures Reservations About Vaccinating All Children 5-11
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.