FDA agrees to review Moderna’s mRNA flu shot : NPR
The Food and Drug Administration said it will review vaccine maker Moderna’s application for a new type of flu vaccine after the company agreed to study it further in older adults.
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Bill Sikes/AP
The Food and Drug Administration shook the biotech industry last week when it I said he wouldn’t even look Moderna’s application to commercialize the first mRNA flu vaccine. But on Wednesday, the agency made an about-face and told Moderna he would review the request with some modifications.
FDA Commissioner Marty Makary alluded during a Pharmaceutical Research and Manufacturers of America event Tuesday that the agency’s refusal to file letter to Moderna was not the end of the company’s firing.
“This letter, in my mind, is part of the conversation where you will see a dialogue between the company and the agency, and they can always, after this letter, request a more detailed review,” he said at the PhRMA forum in Washington, DC. “But it’s part of the process. It’s a conversation.”
The FDA’s change of heart, however, did not reassure the health economist. Rena Conti at Boston Universitywho says the Moderna decisions appear to be part of a pattern with the current FDA. “This type of chaotic decision-making is the opposite of what the regulator should be doing to regulate drugs in the United States,” she said.
Moderna used its mRNA technology to rapidly create and manufacture its COVID-19 vaccine during the pandemic. The company also hopes to use this technology to make flu vaccines. Moderna says the total investment in the shot is more than $1 billion, including up to $750 million from Blackstonean asset management company.
Initially, the FDA said it would not review the new vaccine because the company had not compared it to a high-dose flu vaccine for older people in its main clinical trials.
Moderna said the FDA accepted its study design 18 months ago. “The industry depends on clear, transparent rules that are applied consistently in order to make long-term investments that benefit Americans,” Moderna spokesperson Chris Ridley wrote in an email to NPR last week.
According to a company statementModerna included data from a separate trial comparing its mRNA shot to a high-dose flu vaccine when it submitted the application. “At no time during the meeting or written comments prior to submission, [the FDA’s Center for Biologics Evaluation and Research] indicate that he would refuse to examine the file.”
Department of Health and Human Services spokesperson Andrew Nixon said in an emailed statement to NPR last week that “the FDA rejected Moderna’s filing because the company refused to follow the FDA’s very clear 2024 guidelines to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and effectiveness.”
On Wednesday, Nixon said in an email to NPR that the FDA had a meeting with Moderna, which led the company to modify its application for the experimental vaccine, which the FDA agreed to. “The FDA will maintain its high standards during the review and potential authorization stages, as it does for all products,” he said.
Moderna says it has agreed to add a confirmatory study in older adults that will use a high-dose flu vaccine after the mRNA vaccine comes to market, the company confirmed to NPR.
The company says the new vaccine will be ready for the next flu season, pending FDA approval.
