FDA agrees to review Moderna mRNA flu vaccine in dramatic reversal [View all]

The U.S. Food and Drug Administration will review a messenger RNA (mRNA) flu vaccine for approval, according to its maker, Moderna. The decision is a dramatic U-turn for the agency, which, only about a week ago, had publicly rejected Moderna’s application to get the shot reviewed.

When it initially rejected the application, the FDA had said Moderna’s clinical trials were lacking. On Wednesday, Moderna said it had made modifications to its application. While the reversal has been welcomed by the vaccine maker and public health experts alike, the incident has been the latest instance of the Trump administration undermining vaccine science. Secretary of Health and Human Services Robert F. Kennedy, Jr., whose department has jurisdiction over the FDA, is a noted vaccine skeptic who has repeatedly criticized mRNA COVID vaccines.

HHS spokesperson Andrew Nixon said in a statement that the FDA had held discussions with the company, leading to “a revised regulatory approach and an amended application, which FDA accepted.”

“FDA will maintain its high standards during review and potential licensure stages as it does with all products,” Nixon said.

William Schaffner, an infectious disease physician and a professor at Vanderbilt University Medical Center, says the FDA’s decision to backtrack is “good news.”

https://www.scientificamerican.com/article/fda-agrees-to-review-moderna-mrna-flu-vaccine-in-dramatic-reversal/