STAT+: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy

A panel of advisers to the Food and Drug Administration endorsed Moderna's seasonal mRNA flu vaccine on Thursday, marking a significant step after the vaccine faced controversy earlier this year when a top agency official initially refused to review it. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously concluded that the benefits of the vaccine outweigh the risks for adults aged 50 to 64 and those 65 and older. FDA staff presentations indicated the agency views the vaccine as having met sufficient criteria for licensing through a traditional pathway for the younger demographic and an accelerated pathway for the older group. Wellington Sun, a former FDA employee who previously worked for Moderna, noted during the public comment period that multiple existing flu vaccines were initially licensed via an accelerated pathway. The final decision on the vaccine's approval now rests with the FDA.