Moderna’s May PDUFA date to offer next signal on FDA vaccine policy

Among the eight PDUFA dates on FDA’s May calendar is a BLA for Moderna’s next-generation COVID-19 vaccine. The agency’s decision on the application will send a strong signal about whether any COVID vaccine can still win approval under the Trump administration.

Moderna Therapeutics Inc. (NASDAQ:RNA) used a priority review voucher to expedite evaluation of mRNA-1283, which in Phase III testing was non-inferior to its approved vaccine Spikevax in 11,400 subjects ages 12 and older, meeting the primary immunogenicity endpoint. In adults, mRNA-1283 demonstrated greater efficacy than Spikevax, including those 65 and older. The two vaccines had similar safety profiles...