AYESHA RASCOE, HOST:
Last week, the Food and Drug Administration dealt a surprising setback to Moderna, a biotech company that created one of the mRNA vaccines against COVID-19. The agency rejected Moderna's new flu shot. NPR's Sydney Lupkin is here to talk about the implications. Welcome, Sydney.
SYDNEY LUPKIN, BYLINE: Hi.
RASCOE: Can you walk us through what happened with the Moderna shot?
LUPKIN: Yeah. So this was a first-of-its-kind flu shot that uses the mRNA technology, just like the COVID shots from Moderna and Pfizer BioNTech. Dr. Helen Chu, a professor of medicine and epidemiology at the University of Washington, says the mRNA technology is the reason those companies were able to respond to the COVID pandemic so quickly.
HELEN CHU: And that's important because you need to scale up vaccine manufacturing at quite a clip to be able to make the number of doses that you need to be able to respond to a pandemic.
LUPKIN: So Moderna wants to use that technology again to tackle the flu. The traditional flu shot takes around six months to manufacture because it has to be grown in chicken eggs. So companies have to start making it really early, and by the time it's ready, the flu could've mutated. MRNA could make that process faster and more flexible. But on Tuesday, the FDA said it would not review Moderna's application, effectively rejecting it. It said the agency isn't satisfied with a Moderna study comparing its experimental mRNA flu vaccine to a standard-dose flu vaccine already on the market. A high-potency vaccine is recommended for people 65 and older, and that's what a statement from the Department of Health and Human Services said the FDA was looking for in that age group. HHS said the FDA had communicated that preference before.
RASCOE: So how unusual is this for the FDA to decide not to even review a new vaccine?
LUPKIN: So Chu told me it's unusual to hear from the FDA that a study isn't acceptable so late in the process because companies are talking with the agency before a study even begins to make sure it's OK. But she also told me she was surprised Moderna filed the application. That's because the Trump administration had already been signaling that it wasn't friendly toward mRNA vaccines. Health Secretary Robert F. Kennedy Jr. announced in August that he was cutting a half billion dollars in funding for mRNA vaccine research. He also fired 17 members of an influential vaccine advisory committee - that included Chu - and then the new hand-picked committee recommended making the COVID shots less routine. I should add that the government also reduced the number of vaccines recommended for children beyond just COVID.
RASCOE: What does Moderna say about what happened?
LUPKIN: It says the rejection doesn't line up with what the FDA was saying before and that the agency OK'd this trial design 18 months ago. And by the way, Moderna says it cost a lot of money to do this research, more than a billion dollars all told. Companies making that kind of investment are looking for regulatory consistency. Dr. Lindsay McNair is a consultant at Equipoise and advises companies on clinical trials. She says this isn't the first time in recent months the FDA has done this, and the biotech community is concerned.
LINDSAY MCNAIR: Companies simply cannot afford to conduct clinical trials and then, when they try to submit them to the regulator, have the regulators say, well, changed our minds. We're not going to accept your clinical trial.
RASCOE: So what does this mean for the big picture in terms of flu vaccines, but also companies developing other kinds of vaccines?
LUPKIN: Yeah. So I'm told that when it comes to mRNA vaccines, that work is moving forward, but in other countries. So it's really the United States that could be at a disadvantage here. There's a lot of risk involved in developing a new vaccine - risk the company will do the study and it won't work, or there won't be a market for it and risk that the regulatory agency won't approve it. Those first two are kind of built into the calculus of being a pharmaceutical company, but regulatory risk isn't as much. Historically, in the U.S., the FDA has been pretty consistent. The FDA saying no to a study design it had previously agreed to is risk that's harder to navigate, and it could lead companies to think twice.
RASCOE: That was NPR pharmaceuticals correspondent Sydney Lupkin. Thank you, Sydney.
LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.
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