The failure of Moderna, Inc.’s COVID-19 vaccine booster study to hit one of two immunogenicity endpoints could give a US Food and Drug Administration advisory committee pause in recommending emergency use authorization for the additional dose in at-risk populations.
In briefing documents released ahead of a 14 October meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA said that Moderna’s mRNA vaccine met the success criteria for one immunogenicity endpoint – geometric mean of the neutralizing antibody titers measured 28 days after a