FDA approves Moderna’s mRNA flu shot after review saga
▼ Summary
– The FDA has approved Moderna’s mRNA flu vaccine, mRNA-1010 (mFLUSIVA), for adults aged 50 and older, marking the first mRNA-based flu shot approval.
– The approval followed a unanimous FDA advisor vote in June, based on superior efficacy versus existing flu shots and a safety record from a trial of nearly 44,000 people.
– Health Secretary Robert F. Kennedy Jr., an anti-vaccine advocate, opposed the approval, canceling a flu shot campaign and calling mRNA COVID-19 vaccines the “deadliest ever made.”
– In February, Trump appointee Vinay Prasad refused to review the vaccine, citing incorrect trial comparisons, but the FDA reversed his rejection within a week and removed him from the agency in April.
– Moderna publicly defended its trial design, noting FDA officials had previously approved it, amid the turbulent approval process.
The Food and Drug Administration has granted its first-ever approval of a flu vaccine built on mRNA technology, a landmark decision that arrived after months of internal turmoil and political interference.
Moderna announced Thursday that its shot, mRNA-1010, marketed under the name mFLUSIVA, is now approved for all adults aged 50 and older. The green light follows a unanimous recommendation from FDA advisory panel members in June, who based their vote on the vaccine’s demonstrated superiority over existing seasonal flu shots and a strong safety profile observed in clinical trials involving nearly 44,000 participants. The agency had set an August 5 deadline for its final call.
The advisory panel’s overwhelming support signaled promise for Moderna’s candidate, yet the journey to this approval was anything but smooth. The process was marked by political headwinds and last-minute obstacles that kept the outcome uncertain until the very end.
A central figure in that turbulence is Health Secretary Robert F. Kennedy Jr., a vocal critic of vaccination who has used his position to undermine immunization efforts. Early in his tenure, he scrapped a federally funded campaign promoting flu shots even as the season was proving deadly for children, despite the CDC having already covered the campaign’s costs.
Kennedy’s opposition to mRNA vaccines is particularly pronounced. He has publicly branded the mRNA COVID-19 shot the “deadliest vaccine ever made” and has canceled hundreds of millions of dollars in federal research grants tied to mRNA technology.
The controversy deepened in February when Vinay Prasad, a Trump appointee and Kennedy ally, initially refused to review Moderna’s vaccine application, overruling objections from FDA staff and career officials. The decision stunned both the company and the broader biomedical research community. Prasad justified his stance by claiming Moderna had not compared its vaccine against the appropriate existing flu shot. Moderna pushed back publicly and forcefully, pointing out that FDA officials had previously validated the trial designs. Within a week, the agency reversed Prasad’s rejection, and he was ousted from his position by the end of April following a string of contentious actions that drew widespread criticism.
(Source: Ars Technica)
