A researcher works in the laboratory at Moderna's headquarters in Cambridge, Massachusetts, on March 26, 2024.
Adam Glanzman | Bloomberg | fake images
modern said Wednesday that the Food and Drug Administration has agreed to review its experimental mRNA flu vaccine, reversing the agency's earlier decision to refuse to accept the application in a move that surprised Wall Street and the medical community.
The announcement clears the way forward for the vaccine, which is key to Moderna's experimental flu vaccine combination and the company's goal of breaking even by 2028. The FDA is scheduled to make a decision on the flu vaccine on August 5, which would allow Moderna to have the vaccine available for the upcoming flu season.
“Pending FDA approval, we expect our flu vaccine to be available later this year so that older Americans have access to a new option to protect themselves against the flu,” Moderna CEO Stéphane Bancel said in a statement.
Shares of the biotech company rose more than 6% on Wednesday.
Moderna said it had a “constructive” meeting with the FDA and proposed a revised regulatory approach that addresses criticism the agency made when it declined to accept the application last week, tailoring its new proposal to an older population.
Under the new approach, Moderna is seeking full approval of the vaccine in adults ages 50 to 64 and accelerated approval of the vaccine for people ages 65 and older. The latter means that, once approved, Moderna will have to conduct an additional post-marketing study in older adults to confirm the benefits of the vaccine.
In a statement, Health and Human Services spokesman Andrew Nixon confirmed that the FDA accepted the amended request.
The agency specifically took issue with Moderna's decision to compare its product to a standard flu vaccine approved in a Phase 3 trial, arguing that it “does not reflect the best standard of care available” in the U.S. The FDA's previous comments expressed a preference for Moderna to use a higher-dose vaccine for older adults as a comparator in the trial.
In an interview with CNBC on Wednesday before the announcement, FDA Commissioner Dr. Marty Makary did not indicate that the agency would change course. But he emphasized that the FDA reviewed the application and the initial late-stage trial of the shot when it arrived, so “it's a misnomer to say it wasn't vetted.”
Makary said the agency's guidance to Moderna about its mRNA-based flu vaccine “was pretty clear.” He said the FDA recommended that the group of study participants aged 65 and older who did not receive the Moderna shot receive “standard care, not substandard care” as a comparison product.
Moderna has disputed that reasoning, pointing out that FDA rules and guidelines do not actually require trials to use the more advanced or higher-dose vaccine as a comparator in clinical studies. The company also said it was inconsistent with the FDA's previous written communication about the trial design, even before the study began, where the agency said using the standard flu vaccine would be “acceptable.”
The saga follows sweeping changes to U.S. immunization policy and regulation over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.
Moderna said last week that the decision came specifically from the FDA's top vaccine regulator, Vinay Prasad, who returned to the agency in August after being ousted. Prasad, who heads the agency's Center for Biologics Evaluation and Research, has been vocal about tightening regulations for vaccines and recently linked infant deaths to Covid shots without evidence.
Last week, Moderna published a refusal-to-file letter from the FDA that was signed by Prasad on February 3. HHS does not typically share such letters, and the agency has not provided any details about who drove the decision-making on the company's application.
Asked about his stance on mRNA technology, which Kennedy and some of his supporters have criticized as unsafe, Makary told CNBC on Wednesday that he is “hopeful and optimistic” about the platform, but would also “like to see the data.”
“We're not going to get ahead of the game,” he said. “We're basically going to say, we'd like to see the data, to what extent mRNA technology can be applied is a question that we would love to see applied, to the extent that it can be applied, but it has to meet our scientific standards, so we'll see what happens with cancer and with other infectious diseases…”
