Researchers work in a lab at Moderna’s headquarters in Cambridge, Massachusetts, on March 26, 2024.
Adam Glanzman Bloomberg | Getty Images
moderna announced Wednesday that the Food and Drug Administration has agreed to reconsider an experimental mRNA influenza vaccine, reversing the agency’s previous decision to refuse to accept the application, which surprised Wall Street and the medical community.
The announcement sheds light on Moderna’s experimental combination coronavirus and influenza vaccination and the path forward for the vaccine, which is key to the company’s goal of achieving breakeven by 2028. The FDA is scheduled to make a decision on flu shots on August 5th, which would allow Moderna to make its vaccine available for the upcoming flu season.
“While we await FDA approval, we look forward to making our influenza vaccine available later this year so older Americans have another option to protect themselves from the flu,” Moderna CEO Stéphane Bancel said in a release.
The biotech company’s stock rose more than 6% on Wednesday.
Moderna said it had “constructive” talks with the FDA, proposed revised regulatory approaches that address criticisms the agency made last week when it refused to accept the application, and tailored its new proposal to seniors.
Under the new approach, Moderna is seeking full approval to vaccinate adults ages 50 to 64 and early approval to vaccinate people 65 and older. The latter means that after approval, Moderna will need to conduct additional post-market studies in older adults to confirm the vaccine’s benefits.
Department of Health and Human Services spokesperson Andrew Nixon confirmed in a statement that the FDA had accepted the amended application.
The agency specifically took issue with Moderna’s decision to compare its product to the standard, approved flu shot in a Phase 3 trial, arguing that it “does not reflect the best available standard of care” in the United States. The FDA’s previous feedback indicated that Moderna wanted to use a higher-dose vaccine for older adults as a comparator in the trial.
In an interview with CNBC on Wednesday ahead of the announcement, FDA Commissioner Dr. Marty McCulley did not suggest the agency would change course. But he stressed that the FDA reviewed the application and initial late-stage testing when the shot arrived, so “to say it wasn’t considered is a bit of an understatement.”
McCurry said the agency’s guidance to Moderna regarding mRNA-based influenza shots was “very clear.” He said the FDA recommended that the group of study participants aged 65 and older who did not receive Moderna’s vaccine receive “standard care, not substandard care” as a comparison.
Moderna disputed this reasoning, pointing out that FDA rules and guidance do not actually require trials to use the most advanced or highest-dose vaccines as comparators in clinical studies. The company also said the FDA’s prior written notice of the trial protocol stated that the use of a standard influenza vaccine was “acceptable” even before the study began.
The story follows sweeping changes to U.S. vaccination policy and regulations over the past year under Secretary of Health and Human Services Robert F. Kennedy Jr., a prominent vaccine skeptic.
Moderna said last week that the decision was specifically due to Vinay Prasad, who returned to head the FDA’s vaccine regulator in August after being ousted. Prasad, director of the agency’s Center for Biologics Evaluation and Research, has been a vocal advocate for tighter regulation of vaccines, recently linking a child’s death to COVID-19 vaccination without evidence.
Moderna last week released the so-called FDA application denial letter signed by Prasad on February 3. HHS does not typically share such letters, and the agency has not provided details about who led decision-making regarding the company’s application.
Asked about his stance on mRNA technology, which Kennedy and some allies have criticized as unsafe, McCurry told CNBC on Wednesday that he was “hopeful and optimistic” about the platform but “would like to see the data.”
“We’re not going to take advantage of the game,” he said. “We’re basically going to say we want to see the data to see how far mRNA technology can be applied. We’d like to see how far mRNA technology can be applied, as far as we can apply it. But it has to meet our scientific criteria, so we’ll see what happens in cancer and other infectious diseases…”
