The Food and Drug Administration has agreed to review Moderna’s application for an experimental mRNA-based flu vaccine, reversing an earlier refusal that had surprised investors and public health observers.
Moderna said Wednesday that the agency’s decision clears a path forward for a shot that is central to the company’s long-term strategy, including development of a combined Covid-flu vaccine and its goal of reaching profitability by 2028. The FDA is expected to make a decision on the vaccine by Aug. 5, which could allow Moderna to offer the shot ahead of the upcoming influenza season.
The reversal follows what Moderna described as a constructive meeting with regulators and a revised approval strategy aimed at addressing the agency’s concerns. Under the new approach, Moderna is seeking full approval for adults ages 50 to 64, while requesting accelerated approval for adults 65 and older. Accelerated approval would require Moderna to conduct an additional post-marketing study in older adults to confirm the vaccine’s benefits after it enters the market.
A spokesperson for the Department of Health and Human Services confirmed that the FDA has accepted the modified application confirms.
The FDA’s earlier refusal centered on Moderna’s Phase 3 trial design, which compared its mRNA flu vaccine to a standard-dose, approved flu shot. Regulators argued that the comparison did not reflect the best available standard of care in the United States, particularly for older adults, where higher-dose vaccines are commonly used.
FDA Commissioner Dr. Marty Makary said the agency’s guidance had been clear that trial participants 65 and older who did not receive Moderna’s vaccine should have been given the standard of care rather than what the agency viewed as an inferior comparator.
Moderna has disputed that reasoning, noting that FDA rules do not explicitly require companies to use the highest-dose flu vaccine as a comparator in clinical trials. The company also said the agency had previously indicated that using a standard flu shot would be acceptable before the study began.
The decision comes amid broader shifts in U.S. vaccine regulation under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic. Moderna previously suggested the refusal to accept its application was driven by Vinay Prasad, the FDA’s top vaccine regulator and head of the Center for Biologics Evaluation and Research, who has advocated for tighter vaccine oversight.
The company last week released the FDA’s refusal-to-file letter, signed by Prasad, an unusual move that highlighted tensions between Moderna and regulators.
Source: CNBC