The Food and Drug Administration has reversed its decision on Moderna’s flu vaccine and has agreed to review it for possible approval, Moderna announced on Wednesday.
Last week, the agency had rejected Moderna’s application for review of a new flu vaccine, saying the company’s research design was flawed. But in subsequent discussions the company said that the agency had relented and agreed to begin a review.
Moderna said it split its application for the flu vaccine based on age, seeking a traditional approval for people 50 to 64 years old, and accelerated approval for those 65 and older. The company also said it agreed to conduct an additional study among those 65 and older once the vaccine reached the market.
Moderna said on Wednesday that the F.D.A. set a deadline of August to decide whether to approve the vaccine. If it is authorized, it would be available for those older adults in the flu season that begins later this year.
The vaccine uses messenger RNA technology, which Health Secretary Robert F. Kennedy Jr. has repeatedly criticized as unsafe and ineffective. The mRNA approach, which instructs the body to produce a fragment of a virus that sets off an immune response, was widely successful in Covid vaccines and is considered generally safe by public health experts and scientists.
Despite its development during the first Trump administration, mRNA uses have been extensively curtailed in the last year, sending shock waves through the vaccine industry. Hundreds of millions of dollars in research contracts and projects have been canceled, and agencies under Mr. Kennedy’s purview have sharply limited the recommendations for administering Covid vaccines to certain groups of people.
Dr. Vinay Prasad, the agency’s top vaccine official, signed the letter refusing to accept Moderna’s original application for the vaccine, over the objection of the second-highest ranking vaccine scientist at the F.D.A. Dr. Prasad cited concerns about the control vaccine that Moderna used for people older than 65 in a study of about 41,000 people. He concluded that the vaccine used for comparison was not the best available option.
Moderna spent hundreds of millions of dollars on the study, in addition to a $750 million investment from Blackstone.
Dr. Marty Makary, the F.D.A.’s commissioner, briefly referred on Tuesday evening to last week’s rejection at an event held by PhRMA, the pharmaceutical industry’s trade group, in Washington.
“I think if you’re going to talk about what happened last week,” he said to the moderator of a fireside chat, “you should know the exact details of the trial results, which are public information.”
More broadly on the topic of vaccines, he defended the administration’s sharp paring down of recommended childhood immunizations, saying the changes were meant to increase trust in federal guidance. “I want to see more kids get vaccinated,” he said.
In the company’s earnings call last Friday, Stéphane Bancel, Moderna’s chief executive, told analysts that the F.D.A. risked inhibiting the development of new medical products. “The current uncertainty in the U.S. F.D.A. regulatory environment creates real challenges for businesses, patients and the broader innovation ecosystem,” he said.
Regulators in Europe, Canada and Australia are also reviewing Moderna’s vaccine.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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