The FDA rejected Moderna’s application for a new mRNA flu vaccine, the company said
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The US Food and Drug Administration is refusing to review 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 FDA scrutiny of vaccines 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 so-called “refusal to file” letter from the FDA objecting to the way the company conducted a 40,000-person study comparing its new vaccine to one of the most common flu shots in use today. That study concluded that the vaccine was more effective in adults age 50 and older than the standard shot.
A letter from FDA vaccine director Dr. Vinay Prasad said the agency did not think the application contained an “adequate and well-controlled trial” because it did not compare the new gun to “the best standard of care available in the United States at the time of the study.” Prasad’s letter points to specific advice FDA officials gave to Moderna in 2024, under the Biden administration, which Moderna did not follow.
According to Moderna, that response said it was acceptable to use the standard dose of the flu shot that the company had chosen – but that another type specifically recommended for seniors could be chosen for anyone aged 65 and over in the study. However, Moderna said, the FDA has approved the study to proceed as originally planned.
The company said it also shared with the FDA additional data from a separate trial comparing the vaccine to a higher dose licensed for use in adults.
The FDA “has not identified any safety or efficacy concerns for our product.” Moderna CEO Stephane Bancel said in a statement.
US Health Secretary Robert F. Kennedy Jr. canceled a $500 million grant to develop mNRA vaccine technology. On the National, CBC’s Heather Hiscox asks infectious disease expert Dr. Allison McGeer and health researcher Bradley Wouters to reveal how this could impact the fight against disease in Canada and around the world.
It is not uncommon for the FDA to reject an application, especially for a new vaccine, requiring companies and FDA staff to engage in months or years of negotiations.
Moderna requested an urgent meeting with the FDA, and noted that it has applied for approval of the vaccine in Europe, Canada and Australia.
In the past year, officials working under Kennedy have rolled back recommendations on the COVID-19 shot, added additional warnings to two COVID-19 vaccines — made with mRNA technology — and removed critics of the approach from an FDA advisory panel.
Kennedy announced last year that his department would cancel more than $500 million in contracts and funding for the development of vaccines using mRNA.
The FDA for decades has allowed vaccine makers to quickly update their annual flu shots to target the latest strains by showing that they trigger an immune response in patients. That’s a much more efficient way than running long-term studies to track whether patients get the flu and how they get on.
In an internal memo last year, Prasad wrote that the revised approach would no longer be allowed — prompting more than a dozen former FDA commissioners to write an editorial criticizing the statements.
