The US Food and Drug Administration (FDA) agreed to review Moderna’s mRNA flu vaccine, a week after issuing a Refusal-to-File letter. The regulators changed their stance over the seasonal influenza vaccine candidate mRNA-1010 after the biotech amended its Biologics License Application (BLA). Moderna offered a revised regulatory plan seeking full approval for adults 50 to 64 and accelerated approval for those over 64. The proposal also included an additional, postmarketing study of the vaccine in older people.
The Refusal-to-File letter, signed by Center for Biologics Evaluation and Research Director Vinay Prasad, stated that Moderna’s submission lacked an “adequate and well-controlled study” and that the comparator “does not reflect the best-available standard of care.” The letter did not specify any safety or efficacy concerns with the vaccine. In a statement at the time, Moderna said the letter was “inconsistent with previous written communications from CBER to Moderna.”
