A Food and Drug Administration advisory panel on Thursday recommended the approval of Moderna’s mRNA-based flu shot for older adults.Subscribe to read this story ad-free Get unlimited access to ad-free articles and exclusive content.If approved, it would be the world’s first messenger RNA flu shot, providing public health officials with a much more nimble tool to fight influenza.
In a late-stage trial, the vaccine was found to be about 27% more effective than a standard flu shot.Despite the panel’s unanimous endorsement, questions remain about whether Americans will be able to get the vaccine, called mFlusiva, this fall.The shot must still be approved by the FDA and formally recommended by the Centers for Disease Control and Prevention’s advisory committee, which has been blocked from convening by a federal judge.The Department of Health and Human Services, which oversees the FDA, has been hostile to mRNA technology under Health Secretary Robert F.
Kennedy Jr.He’s called the mRNA Covid shot “the deadliest vaccine ever made,” and last year HHS canceled nearly $500 million in funding for mRNA vaccine research.The path to approval of Moderna’s flu vaccine has been touch and go.
Earlier this year, the FDA initially refused to even review the company’s application for the shot, before reversing course a week later.FDA officials said the initial application was rejected because of Moderna’s decision to compare its vaccine to a standard flu shot in adults 65 and up, even though the CDC recommends this age group get a high-dose version of the vaccine.(Moderna said that the FDA had previously signed off on its trial design.) The trial design for older adults was a robust topic of conversation during Thursday’s meeting.
Ultimately, the panel — the agency’s Vaccines and Related Biological Products Advisory Committee — recommended approval for two age groups: adults 50 to 64 and adults 65 and up, with the caveat that Moderna is required to run...