"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."
"William Schaffner, an infectious disease physician and a professor at Vanderbilt University Medical Center, says the FDA's decision to backtrack is good news. It is important to give all candidate new vaccines a fair equitable assessment. This is especially true for new mRNA-based vaccine"
The FDA reversed an initial rejection and will now review Moderna's mRNA influenza vaccine after the company amended its application. The original rejection cited deficiencies in Moderna's clinical trials. HHS reported that FDA discussions with Moderna produced a revised regulatory approach and acceptance of the amended application. HHS asserted that FDA will maintain high standards during review and potential licensure stages. Public health experts responded positively to the decision, while observers noted political tensions because Secretary Robert F. Kennedy, Jr. has been a prominent vaccine skeptic and critic of mRNA COVID vaccines.
Read at www.scientificamerican.com
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