The Meals and Drug Administration rejected Moderna’s new flu shot. This raises questions on what it means for the way forward for vaccine improvement.
AYESHA RASCOE, HOST:
Final week, the Meals and Drug Administration dealt a stunning setback to Moderna, a biotech firm that created one of many mRNA vaccines in opposition to COVID-19. The company rejected Moderna’s new flu shot. NPR’s Sydney Lupkin is right here to speak concerning the implications. Welcome, Sydney.
SYDNEY LUPKIN, BYLINE: Hello.
RASCOE: Are you able to stroll us by what occurred with the Moderna shot?
LUPKIN: Yeah. So this was a first-of-its-kind flu shot that makes use of the mRNA expertise, identical to the COVID photographs from Moderna and Pfizer BioNTech. Dr. Helen Chu, a professor of medication and epidemiology on the College of Washington, says the mRNA expertise is the rationale these firms had been ready to reply to the COVID pandemic so rapidly.
HELEN CHU: And that is vital as a result of you have to scale up vaccine manufacturing at fairly a clip to have the ability to make the variety of doses that you just want to have the ability to reply to a pandemic.
LUPKIN: So Moderna desires to make use of that expertise once more to deal with the flu. The standard flu shot takes round six months to fabricate as a result of it needs to be grown in hen eggs. So firms have to start out making it actually early, and by the point it is prepared, the flu may’ve mutated. MRNA may make that course of sooner and extra versatile. However on Tuesday, the FDA stated it could not assessment Moderna’s utility, successfully rejecting it. It stated the company is not glad with a Moderna research evaluating its experimental mRNA flu vaccine to a standard-dose flu vaccine already in the marketplace. A high-potency vaccine is really helpful for folks 65 and older, and that is what an announcement from the Division of Well being and Human Companies stated the FDA was on the lookout for in that age group. HHS stated the FDA had communicated that desire earlier than.
RASCOE: So how uncommon is that this for the FDA to determine to not even assessment a brand new vaccine?
LUPKIN: So Chu instructed me it is uncommon to listen to from the FDA {that a} research is not acceptable so late within the course of as a result of firms are speaking with the company earlier than a research even begins to ensure it is OK. However she additionally instructed me she was shocked Moderna filed the appliance. That is as a result of the Trump administration had already been signaling that it wasn’t pleasant towards mRNA vaccines. Well being Secretary Robert F. Kennedy Jr. introduced in August that he was reducing a half billion {dollars} in funding for mRNA vaccine analysis. He additionally fired 17 members of an influential vaccine advisory committee – that included Chu – after which the brand new hand-picked committee really helpful making the COVID photographs much less routine. I ought to add that the federal government additionally decreased the variety of vaccines really helpful for youngsters past simply COVID.
RASCOE: What does Moderna say about what occurred?
LUPKIN: It says the rejection does not line up with what the FDA was saying earlier than and that the company OK’d this trial design 18 months in the past. And by the best way, Moderna says it value some huge cash to do that analysis, greater than a billion {dollars} all instructed. Corporations making that sort of funding are on the lookout for regulatory consistency. Dr. Lindsay McNair is a marketing consultant at Equipoise and advises firms on medical trials. She says this is not the primary time in current months the FDA has accomplished this, and the biotech group is worried.
LINDSAY MCNAIR: Corporations merely can not afford to conduct medical trials after which, once they attempt to submit them to the regulator, have the regulators say, nicely, modified our minds. We’re not going to simply accept your medical trial.
RASCOE: So what does this imply for the large image by way of flu vaccines, but in addition firms growing different kinds of vaccines?
LUPKIN: Yeah. So I am instructed that in the case of mRNA vaccines, that work is transferring ahead, however in different nations. So it is actually america that could possibly be at an obstacle right here. There’s a variety of danger concerned in growing a brand new vaccine – danger the corporate will do the research and it will not work, or there will not be a marketplace for it and danger that the regulatory company will not approve it. These first two are sort of constructed into the calculus of being a pharmaceutical firm, however regulatory danger is not as a lot. Traditionally, within the U.S., the FDA has been fairly constant. The FDA saying no to a research design it had beforehand agreed to is danger that is more durable to navigate, and it may lead firms to assume twice.
RASCOE: That was NPR prescription drugs correspondent Sydney Lupkin. Thanks, Sydney.
LUPKIN: You guess.
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