"The dispute centered over a 40,000-person clinical trial that concluded Moderna's new vaccine was more effective in adults age 50 and older than one of the standard flu shots used today. In the FDA's rare "refusal to file" letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically recommended for people 65 and older."
"It said that while the FDA had recommended that approach, the agency ultimately agreed to the study's design - and that the company shared additional comparison data from a separate trial that used a high-dose shot for older people. Nor did the FDA identify any safety concerns. Still, Moderna said Wednesday that in a compromise, it is seeking full approval for the vaccine's use in adults 50 to 64 and accelerated approval for those 65 and older, with an additional study once the shot is on the market."
FDA will consider Moderna's application for a new mRNA flu vaccine after a dispute that had halted review. A 40,000-person trial found the vaccine more effective in adults 50 and older compared with a standard flu shot, but the FDA's refusal to file cited lack of a comparison with a brand specifically recommended for people 65 and older. Moderna provided additional comparison data and agreed to seek full approval for adults 50–64 and accelerated approval for those 65+, with a required post-market study for older adults. The FDA aims for a decision by Aug. 5 and Moderna hopes to make the vaccine available later this year. The case unfolds amid heightened FDA scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.
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