FDA rejects Moderna’s new mRNA flu vaccine application, company says
listen to this article
estimated 3 minutes
The audio version of this article has been generated by AI-based technology. There may be incorrect pronunciations. We are working with our partners to continually review and improve results.
The US Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.
The news is the latest sign of heightened scrutiny of vaccines by the FDA under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized — both before and after becoming the nation’s top health official.
Moderna received a “refusal to file” letter from the FDA, objecting to the fact that the company compared its new vaccine with one of the standard flu shots used today on 40,000 people. That trial concluded that the new vaccine was somewhat more effective than the standard shot in adults ages 50 and older.
The letter from FDA vaccine director Dr. Vinay Prasad said the agency does not consider the application an “adequate and well-controlled trial” because it did not 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 given to Moderna by FDA officials in 2024 under the Biden administration, which Moderna did not follow.
According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot chosen by the company — but that another brand recommended specifically for seniors would be preferred for anyone 65 and older in the study. Nevertheless, Moderna said, the FDA agreed to let the study proceed as originally planned.
The company said it also shared additional data with the FDA from a separate trial that compared the new vaccine against a licensed higher-dose shot used for seniors.
The FDA “did not identify any safety or efficacy concerns with our product.” Moderna CEO Stéphane Bancel said in a statement.
US Health Secretary Robert F. Kennedy Jr. has canceled $500 million in funding for the development of MNRA vaccine technology. For The National, CBC’s Heather Hiscox asked infectious disease expert Dr. Alison McGirr and health researcher Bradley Wouters to explain what kind of impact it could have on fighting the disease in Canada and around the world.
It is rare that the FDA refuses to file an application, especially for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions.
Moderna has requested an urgent meeting with the FDA, and noted that it has applied for approval of the vaccine in Europe, Canada and Australia.
Officials who served under Kennedy last year Recommendations on COVID-19 shots withdrawnadded Additional warnings For the two major COVID vaccines – which are made with mRNA technology – and critics removed Regarding the Administration’s perspective from the FDA Advisory Panel.
Kennedy announced last year that his department would Cancel contracts worth more than $500 million and funding for the development of vaccines using mRNA.
The FDA has for decades allowed vaccine makers to quickly update their annual flu shots to target the latest strains, finding that they trigger immune responses in patients. This is a far more efficient approach than running long-term studies tracking whether patients have the flu and how they are doing.
In an internal memo last year, Prasad wrote that the streamlined methodology would no longer be allowed — prompting more than a dozen former FDA commissioners to write an editorial condemning the statements.
