Free daily briefing on global business news.
The vaccine, called mFlusiva, is the first mRNA-based flu shot to receive regulatory approval anywhere in the world
Moderna $MRNA received FDA approval on Wednesday for mFlusiva, its mRNA-based seasonal flu vaccine, making it the first shot of its kind to clear a regulatory body worldwide. The vaccine is approved for adults 50 years and older and becomes Moderna's fourth FDA-approved product.
Traditional approval for the 50-to-64 age group rested on Phase 3 data drawn from more than 40,000 people in 11 countries, which showed mFlusiva reduced influenza cases by 26.6% relative to a standard-dose shot. Adults 65 and older received accelerated approval based on immunogenicity data; Moderna has agreed to conduct a postmarketing trial to confirm clinical benefit in that age group, the company said.
"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors," Moderna Chief Executive Officer Stéphane Bancel said in a statement.
