The US Food and Drug Administration offered treats and probably a little bit of a scare to COVID vaccine sponsors on the Friday before Halloween when it gave Pfizer Inc. emergency use authorization for its COVID-19 vaccine in children 5-11 and then apparently told Moderna, Inc. that safety concerns would extend the review of its vaccine for use in 12- to 17-year-olds.
With Pfizer EUA For 5-11 And Moderna Delay For Adolescents, US FDA Walks Myocarditis Tightrope
COVID vaccine safety concerns from international analyses will force sponsors and FDA to again confront the challenge of how to make bad news for one shot not turn into bad news for all.
