FDA backtracks and agrees to review Moderna mRNA flu vaccine after initial rejection

WASHINGTON (AP) — The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.

Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.

The dispute centered over a 40,000-person clinical trial that concluded Moderna’s new vaccine was more effective in adults age 50 and older than one of the standard flu shots used today. In the FDA’s rare “refusal to file” letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically recommended for people 65 and older.

Moderna publicly objected. It said that while the FDA had recommended that approach, the agency ultimately agreed to the study’s design — and that the company shared additional comparison data from a separate trial that used a high-dose shot for older people. Nor did the FDA identify any safety concerns.

Still, Moderna said Wednesday that in a compromise, it is seeking full approval for the vaccine’s use in adults 50 to 64 and accelerated approval for those 65 and older, with an additional study once the shot is on the market. Shares of Moderna Inc. rose more than 5% after the announcement in morning trading.

The FDA is targeting a decision on the application by Aug. 5, and Moderna said it hoped to make the vaccine available later this year. It also has applied for the vaccine’s approval in Europe, Canada and Australia.

The highly unusual public dispute was the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.

In the past year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines — which are made with mRNA technology — and removed critics of the administration’s approach from an FDA advisory panel.

This story was originally featured on Fortune.com