The US Food and Drug Administration has reversed course and will review a brand new mRNA flu vaccine from Moderna, the pharmaceutical company mentioned Wednesday.
About two weeks in the past, the FDA despatched Moderna a letter wherein it refused to just accept the applying to review its first mRNA seasonal flu vaccine — a rare move by the federal company.
The FDA told Moderna that its utility didn’t comprise an “adequate and well-controlled” trial as a result of the management arm didn’t mirror the “best-available standard of care in the United States at the time of the study,” in accordance with the letter, that Moderna posted on-line. It didn’t determine any security or efficacy issues, the company mentioned.
But Moderna has since met with the FDA and “proposed a revised regulatory approach” with totally different pathways by age, in accordance with a information launch from the company.
Moderna is now “seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults,” the information launch mentioned.
If the FDA approves the vaccine, it could possibly be obtainable for folks ages 50 and older for the upcoming 2026-2027 flu season.
Last week, Moderna mentioned that the preliminary refusal from the FDA was inconsistent with earlier suggestions from the company.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel mentioned in a press release. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
NCS’s Meg Tirrell and Adam Cancryn contributed to this report.