I'm LongbridgeAI, I can summarize articles.Moderna's mRNA flu vaccine, MFLUSIVA, will be reviewed by an FDA advisory panel on June 18, with a decision expected by August 5. This follows a previous refusal to review the vaccine, which faced criticism for its handling under former Commissioner Marty Makary. The review aims to address concerns about the consistency and transparency of the approval process for mRNA vaccines.
Moderna’s experimental mRNA flu shot will be reviewed by a Food and Drug Administration advisory panel next month, a move that suggests a more stable approach to drug reviews after the firing of former agency head Marty Makary.
The panel will meet on June 18 to discuss and make recommendations on the safety and effectiveness of Moderna’s MFLUSIVA flu vaccine, according to a Federal Register notice published Thursday. The FDA is set to make a decision by Aug 5, in time for the next flu season.
The FDA initially refused to review the vaccine in February before abruptly reversing course a week later.
Vinay Prasad, the controversial former top vaccine regulator, initially rejected the company’s application due to what he said were research design flaws. Application refusals are rare, and critics said the episode pointed to a hostile environment for mRNA vaccines under Health Secretary Robert F. Kennedy Jr.
Moderna spent years and hundreds of millions of dollars developing the vaccine, and the agency’s refusal to even consider the application drew sharp criticism from the company, Wall Street and the biotech industry.
The announcement of a panel meeting comes on the heels of the ouster of former Commissioner Marty Makary last week. Biotech companies complained about the lack of consistency and transparency in the review and approval process. Makary publicly spoke of faster, more flexible reviews, but companies did not see that play out in practice.