Moderna, FDA reach compromise to accelerate approval of mRNA flu vaccine
A first-of-its-kind mRNA vaccine for the flu developed by Moderna will be considered for approval by the U.S. Food and Drug Administration (FDA) after all, despite the agency initially rejecting the shot.
Moderna announced the change today, roughly a week after the company said the FDA was refusing to review it, citing a clinical trial that vaccine chief Vinay Prasad, MD, flagged for failing to include a traditional alternative from another company—specifically one recommended for people 65 and older, a demographic targeted in the application.
Prasad’s challenge resulted in a “refusal to file” letter, which would have effectively forced Moderna to commission more clinical research to prove its mRNA flu vaccine—made from the same technology used in its COVID-19 shot—is safe and effective.
The clinical trial submitted by Moderna involved 40,000 people and showed the vaccine was more effective at preventing severe flu than standard inactivated virus offerings on the market. The study focused on adults 50 and older, but not those over 65.
In its response to the FDA’s rejection, the Massachusetts-based pharmaceutical company expressed shock, saying the agency had agreed to the study design before it was conducted. It acknowledged that regulators pushed for those 65 and older to be the focus, but said the two parties settled on a separate data analysis that demonstrated safety for seniors.
Moderna said it submitted comparisons showing that, even at a high dose, its mRNA flu shot was safe for those 65 and older. However, no head-to-head comparison was conducted in that age group using a brand-name alternative vaccine.
Terms of the compromise
The dispute, centered entirely on age limits, was the source of the rejection. Now it appears Moderna has refiled, seeking approval for its flu vaccine for adults ages 50 to 64.
For adults 65 and older, the company is still requesting approval, with the stipulation that an additional study be conducted once the vaccine becomes publicly available.
That was enough to appease the FDA, which has now allowed the submission process to move forward. Moderna is seeking accelerated approval status.
If approved, the vaccine would become the only mRNA flu vaccine available for older adults, though traditional flu vaccines would remain an option.
There are no federal laws making flu shots compulsory, though some health care settings may require them for workers.
This is a developing story.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.