Moderna says FDA refuses its application for new mRNA flu vaccine

"The news is the latest sign of the FDA's heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation's top health official. Moderna received what's called a "refusal-to-file" letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today."

"The letter from FDA vaccine director Dr. Vinay Prasad said the agency doesn't consider the application to contain an "adequate and well-controlled trial" because it didn't compare the new shot to "the best-available standard of care in the United States at the time of the study." Prasad's letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn't follow."

The FDA issued a refusal-to-file for Moderna's mRNA flu vaccine application, citing that the 40,000-person trial did not compare the shot to the best-available U.S. standard of care. The trial compared the new vaccine to a standard-dose flu shot and found somewhat improved effectiveness in adults 50 and older. FDA vaccine director Dr. Vinay Prasad referenced prior FDA advice recommending a different brand for seniors ages 65 and older, guidance Moderna did not follow. Moderna said the FDA had agreed to let the study proceed and that the company submitted additional data comparing the vaccine to a licensed high-dose senior shot.

Read at Boston.com