As FDA Advisers Grow Comfortable With EUAs, Harder Decisions On J&J’s Vaccine Fall To States, Individuals
J&J’s COVID-19 vaccine sails through its US FDA advisory panel, but that just means the subpopulation efficacy questions need to be wrestled with by other public health space, as CDC and the states must figure out the best way to distribute multiple vaccines with differing efficacy profiles, regimens and storage requirements.
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FDA and CDC advisory committee members wonder how to use the single-shot J&J vaccine if an ongoing study shows two doses are better than one.
US FDA’s Peter Marks notes timeframe for sponsors to seek licensure at press call announcing emergency use authorization of J&J’s vaccine; Acting Commissioner Woodcock says effectiveness comparisons cannot be made between the three authorized vaccines since they have not been tested head-to-head.
The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.