Moderna has developed a new flu vaccine, but what’s the problem they face?
The U.S. Food and Drug Administration is refusing to consider Moderna’s application for the vaccine made with the Nobel Prize-winning mRNA technology.
The move points toward increased oversight of vaccines by the FDA operating under Secretary of Health 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 a so-called “denial to file” letter from the FDA, objecting to the way it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.
That study concluded that the new vaccine was slightly more effective in adults aged 50 and over than the standard injection.
In the letter from FDA vaccine director Dr. Vinay Prasad says the agency does not consider the application an “adequate and well-controlled study” 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 also referenced some advice that FDA officials gave to Moderna in 2024, under the Biden administration, but which Moderna did not follow.
According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company chose, but that a different brand specifically recommended for seniors would be preferred for everyone 65 and older in the study. Still, Moderna said the FDA agreed to let the study proceed as originally planned.
The FDA “has not identified any safety or efficacy issues with our product” and “does not advance our shared goal of advancing U.S. leadership in the development of innovative medicines,” Moderna CEO Stephane Bancel said in a statement.
It’s rare for the FDA to refuse to submit 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 emergency meeting with the FDA and revealed that it has applied for approval of the vaccine in Europe, Canada and Australia.
