FDA agrees to review Moderna’s flu shot application after refusal

Moderna Food and Drug Administration on Wednesday agreed to review The experimental mRNA flu vaccine reversed the agency’s earlier decision to refuse to accept the application, in a move that stunned Wall Street and the medical community.

The announcement paves the way forward for Moderna’s experimental combination Covid-flu vaccine, which is key to the company’s goal of breakeven by 2028. The FDA is scheduled to make a decision on the flu vaccine on August 5, which will allow Moderna to make the vaccine available for the upcoming flu season.

“We look forward to making our flu vaccine available later this year, pending FDA approval, so American seniors have access to a new option to protect themselves against the flu,” Moderna CEO Stéphane Bancel said in a statement.

Shares of the biotechnology company rose more than 6% on Wednesday.

Moderna said it had a “constructive” meeting with the FDA and proposed a revised regulatory approach that tailors its new proposal to an older population, responding to criticism the agency made last week when it refused to accept the application.

Under the new approach, Moderna is seeking full approval for 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 approval is granted, Moderna will have to conduct an additional post-marketing study in older adults to confirm the vaccine’s benefits.

Health and Human Services spokesman Andrew Nixon confirmed in a statement that the FDA accepted the amended application.

The agency specifically objected to Moderna’s decision to compare its product to a standard, approved flu vaccine 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 expressed a preference for Moderna to use a higher dose of 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 reverse course. But he emphasized that the FDA is reviewing the application and the early-stage trial when the vaccine arrives, so “to say it hasn’t been looked at is a bit of a misnomer,” he said.

Makary said the agency’s guidance to Moderna on its mRNA-based flu vaccine was “pretty clear.” He said the FDA recommended that the group of participants 65 and older who did not receive the Moderna vaccine receive “standard care, not substandard care” as a comparison product.

Moderna disputed this logic, stating that FDA rules and guidelines do not actually require trials to use the most advanced or highest-dose vaccine as a comparator in clinical studies. The company also said this was inconsistent with the FDA’s previous written communication regarding the study design, even before the study began, when the agency said it would be “acceptable” to use the standard flu vaccine.

The saga follows sweeping changes to U.S. vaccination policy and regulations last year under the administration of Health and Human Services Secretary Robert F. Kennedy Jr., a leading vaccine skeptic.

Last week, Moderna said the decision was specifically driven by Vinay Prasad, the FDA’s top vaccine regulator, who returned to the agency in August after being ousted. Prasad, who heads the agency’s Center for Biological Evaluation and Research, has been vocal about tightening regulations on vaccines and recently linked child deaths to Covid vaccines without any evidence.

Last week, Moderna released the FDA’s so-called Refusal to File letter signed by Prasad on February 3. HHS generally does not share these letters, and the agency did not provide any details about who led the decision-making process 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 was “hopeful and optimistic” about the platform but also “wanted to see the data.”

“We won’t be able to get ahead of the game,” he said. “Basically what we’re going to say is we want to see the data, how much mRNA technology can be applied is a question that we’d like to see implemented to the extent that it can be implemented, but it has to meet our scientific standards, so we’ll see what happens with cancer and other infectious diseases…”