Turning COVID-19 Vaccine EUA Into A BLA Will Require Six Months Of Additional Data
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.
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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.
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.
Efficacy against moderate to severe/critical COVID-19 was 66%-67%, well above the FDA’s stated 50% efficacy threshold for an EUA but far short of the 94%+ efficacy rates posted by the Pfizer and Moderna vaccines against symptomatic disease; agency says efficacy against specific variants cannot be evaluated at this time because sequencing data are incomplete.