FDA vaccine panel set to review Moderna mRNA flu shot

Thank you for signing up!

Subscribe to more newsletters here

FDA panel set to review Moderna mRNA flu shot 

FDA’s vaccine advisors seem open to Moderna’s candidate for a mRNA flu vaccine ahead of a key meeting on Thursday. The company is seeking traditional approval for people aged 50 to 64, and accelerated approval for those 65 and older. 

© AP Photo/Bill Sikes

FDA’s Vaccines and Related Biological Products Advisory Committee will vote on whether the benefits outweigh the risks for each population group.  

The FDA initially refused to review the vaccine in February before abruptly reversing course a week later. In briefing documents, FDA staff indicated there were no safety concerns and that the data submitted by Moderna supports the vaccine’s efficacy in the older group. 

The company’s immunogenicity data suggested the shot is at least as effective as the current high-dose vaccine the Centers for Disease Control and Prevention recommends for people 65 and older, and “offers unique potential advantages compared to vaccines currently licensed for individuals 50 to 64 years of age.” 

Moderna said it will run an additional study and submit more data in adults 65 and older if they get approval for that age group. 

Earlier this year, Vinay Prasad, the controversial former top vaccine regulator, said FDA wasn’t even going to consider the vaccine because Moderna’s data was not strong enough.  

Application refusals are rare, and critics said the episode pointed to a hostile environment for mRNA vaccines under Health and Human Services Secretary Robert F. Kennedy Jr. 

Moderna spent years and hundreds of millions of dollars developing the vaccine,........

© The Hill