FDA refuses Moderna’s utility for brand new mRNA flu vaccine, firm says

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The U.S. Meals and Drug Administration is refusing to think about Moderna’s utility for a brand new flu vaccine made with Nobel Prize-winning mRNA expertise, the corporate introduced Tuesday.

The information is the most recent signal of the FDA’s heightened scrutiny of vaccines beneath Well being Secretary Robert F. Kennedy Jr., notably these utilizing mRNA expertise, which he has criticized — each earlier than and after changing into the nation’s prime well being official.

Moderna acquired what’s referred to as a “refusal-to-file” letter from the FDA that objected to how the corporate carried out a 40,000-person medical trial evaluating its new vaccine to one of many normal flu pictures used at this time. That trial concluded the brand new vaccine was considerably simpler in adults 50 and older than that normal shot.

The letter from FDA vaccine director Dr. Vinay Prasad mentioned the company doesn’t contemplate the appliance to include an “ample and well-controlled trial” as a result of it didn’t evaluate the brand new shot to “the best-available normal of care in the US on the time of the examine.” Prasad’s letter pointed to some recommendation FDA officers gave Moderna in 2024, beneath the Biden administration, which Moderna didn’t observe.

<img loading="lazy" alt="a man in a suit with a blue collared shirt speaks at a podium gesturing with one hand, while another man in a suit looks at him from his place a few steps back from the podium" srcset="https://i.cbc.ca/ais/545419d3-2b61-4bf7-a4e6-8a25540973b0,1770821189209/full/max/0/default.jpg?im=Crop%2Crect%3D%280%2C0%2C5648%2C3765%29%3BResize%3D796 796w,https://i.cbc.ca/ais/545419d3-2b61-4bf7-a4e6-8a25540973b0,1770821189209/full/max/0/default.jpg?im=Crop%2Crect%3D%280%2C0%2C5648%2C3765%29%3BResize%3D1083 1083w,https://i.cbc.ca/ais/545419d3-2b61-4bf7-a4e6-8a25540973b0,1770821189209/full/max/0/default.jpg?im=Crop%2Crect%3D%280%2C0%2C5648%2C3765%29%3BResize%3D1280 1280w" sizes="(max-width: 762px) calc(100vw - 32px),730px" src="https://i.cbc.ca/ais/545419d3-2b61-4bf7-a4e6-8a25540973b0,1770821189209/full/max/0/default.jpg?im=Crop%2Crect%3D%280%2C0%2C5648%2C3765%29%3B" style="aspect-ratio:1.500132802124834" data-cy="image-img"/> Secretary of Well being and Human Providers Robert F. Kennedy Jr. speaks within the Oval Workplace of the White Home, Tuesday, Sept. 30, 2025, in Washington, as President Donald Trump seems to be on. (Alex Brandon/Related Press) In response to Moderna, that suggestions mentioned it was acceptable to make use of the standard-dose flu shot the corporate had chosen — however that one other model particularly advisable for seniors can be most well-liked for anybody 65 and older within the examine. Nonetheless, Moderna mentioned, the FDA did comply with let the examine proceed as initially deliberate.

The corporate mentioned it additionally had shared with the FDA further information from a separate trial evaluating the brand new vaccine in opposition to a licensed high-dose shot used for seniors.

The FDA “didn't determine any security or efficacy considerations with our product.” Moderna CEO Stephane Bancel mentioned in an announcement.

WATCH | The U.S. simply killed mRNA vaccine funding — what now?: The U.S. simply killed mRNA vaccine funding — what now?

U.S. Well being Secretary Robert F. Kennedy Jr. has cancelled $500 million in funding for the event of mNRA vaccine expertise. For The Nationwide, CBC’s Heather Hiscox asks infectious illness specialist Dr. Allison McGeer and well being researcher Bradley Wouters to interrupt down what sort of impression this might have on combating illness in Canada and all over the world. It’s uncommon that the FDA refuses to file an utility, notably for a brand new vaccine, which requires corporations and FDA employees to interact in months or years of discussions.

Moderna has requested an pressing assembly with FDA, and famous that it has utilized for the vaccine’s approval in Europe, Canada and Australia.

Within the final yr, officers working beneath Kennedy have rolled again suggestions round COVID-19 pictures, added additional warnings to the 2 main COVID vaccines — that are made with mRNA expertise — and eliminated critics of the administration’s method from an FDA advisory panel.

Kennedy introduced final yr that his division would cancel greater than $500 million in contracts and funding for the event of vaccines utilizing mRNA.

The FDA for many years has allowed vaccine makers to rapidly replace their annual flu pictures to focus on the most recent strains by displaying that they set off an immune response in sufferers. That’s a much more environment friendly method than working long-term research monitoring whether or not sufferers get the flu and the way they fare.

In an inner memo final yr, Prasad wrote that the streamlined methodology would now not be permitted – main greater than a dozen former FDA commissioners to pen an editorial condemning the statements.