(TNND) — The Food and Drug Administration reversed course on Wednesday and agreed to formally review Moderna’s new flu vaccine, which uses mRNA technology, Moderna announced in a news release.
Earlier this month, the FDA refused to review Moderna’s application for approval, arguing the company’s clinical trial didn’t include a comparison vaccine specifically recommended for people 65 and older.
Health and Human Services (HHS) Spokesman Andrew Nixon told The National News Desk via email that the FDA rejected Moderna’s application for filing because “the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.”
Moderna exposed study participants age 65 and over to increased risk of severe illness by giving them a “substandard of care” against the recommendation of FDA scientists, according to Nixon.
“The most protective flu shots for seniors are a subset of high dose flu shots recommended by the CDC Advisory Committee on Immunization Practices, which would have served as the proper control in this study,” he said.
Moderna publicly objected and requested a meeting with the FDA after receiving a “refusal-to-file” letter. The company also pointed out that the vaccine is under review in other countries such as Europe, Canada and Australia.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Stéphane Bancel, Chief Executive Officer, said. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
The FDA is aiming for a decision on the application by Aug. 5.
In August, HHS Secretary Robert F. Kennedy Jr. announced the winding down and cancellation of roughly $500 million in federal funding for mRNA vaccine development programs.
Kennedy promoted whole-virus vaccines and novel platforms instead of mRNA vaccines.
“Let me explain why,” Kennedy said in a video. “Most of these shots are for flu or COVID. But as the pandemic showed us, mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract. Here’s the problem, mRNA only codes for a small part of the viral proteins, usually a single antigen. One mutation and the vaccine becomes ineffective.”
Kennedy said the risks outweigh the benefits with mRNA.
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Editor’s note: The National News Desk’s Cory Smith contributed to this article.
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