Mix and Match COVID Boosters: Time Crunch For Data Review May Mean No Advisory Committee Vote
US FDA can’t say whether it will have its vaccine advisors vote on the heterologous uses of booster doses at its 14-15 October meeting of the Vaccines and Related Biological Products Advisory Committee because it is still reviewing the data. The Agency does not appear to need a formal company application or emergency use authorization amendment to allow this type of boosting.
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Discussion also reopened the debate on allowing universal boosting with mRNA vaccines, with advisors giving FDA more leeway to allow some younger Americans to get an additional mRNA shot regardless of their occupation or underlying health conditions.
Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.
Though not designed to facilitate inter-group comparisons, a preprint study of heterologous and homologous boosting with the three US available COVID-19 vaccines indicate Johnson and Johnson primary vaccines may get greater protection from an mRNA booster.