Shares of Moderna rose Wednesday after the Food and Drug Administration reversed its earlier refusal and agreed to review the company’s new flu vaccine, clearing a path that had appeared suddenly blocked just days before.
The FDA had initially declined to even open Moderna’s application, saying it did not include enough research.
The letter, signed by Dr. Vinay Prasad, the agency’s top vaccine official, left Moderna’s president, Dr. Stephen Hoge, stunned.
“I was completely surprised and honestly pretty confused,” Hoge said in an interview, recalling the moment he read the agency’s decision. “The letter actually just said, ‘We’re not even going to open it.'”
After a Type A meeting between regulators and the company, the FDA accepted a revised application.
“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Health and Human Services spokesperson Andrew Nixon said.
He added that the agency “will maintain its high standards during review and potential licensure stages as it does with all products.”
The FDA has set an August 5 deadline to decide whether to approve the vaccine. If cleared, the shot could be available for the 2026–2027 flu season.
Moderna is now seeking full approval for adults ages 50 to 64 and accelerated approval for those 65 and older.
The accelerated path would require the company to complete a follow-up study in seniors after the vaccine reaches the market. Moderna agreed to conduct that additional research.
Moderna’s mRNA Flu Shot Back Under FDA Review
The new flu shot uses messenger RNA, or mRNA, the same technology used in many COVID-19 vaccines.
Though widely considered safe by most medical professionals, the approach has faced criticism from Health Secretary Robert F. Kennedy Jr., who has questioned whether mRNA shots pose “more risks than benefits.”
Under his leadership, federal funding for some mRNA vaccine projects has been cut.
The dispute became unusually public. Moderna disclosed details of the FDA’s rejection letter and said the agency had approved the trial design 18 months earlier when the study began.
The clinical trial involved more than 40,000 participants and cost the company more than $1 billion, supported in part by a $750 million investment from Blackstone.
Some analysts said the reversal could restore confidence. One described the decision as potentially bringing back a revenue stream that had been left in limbo.
Dr. Jesse Goodman, a former FDA chief scientist, called the final approach “very sensible,” but said the path to get there was “a really badly done process.”
Originally published on vcpost.com
