Moderna's mRNA flu vaccine wins key FDA backing, sending shares soaring
Moderna's mRNA flu vaccine wins key FDA backing, sending shares soaring
Moderna's mRNA flu vaccine wins key FDA backing, sending shares soaring
Moderna’s shares rose sharply after positive FDA feedback on its mRNA flu vaccine, mFlusiva. The company also announced a new hire as it prepares for future product launches. Regulators will soon review the vaccine’s potential benefits for older adults. The FDA released briefing documents stating no major issues were found in Moderna’s application for mFlusiva. This news caused the company’s stock to jump by as much as 9.1%. The vaccine showed stronger protection than standard flu shots in people aged 50 to 64.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on June 18 to decide if mFlusiva’s benefits outweigh its risks for those 50 and older. A final FDA decision is expected by August 5. If approved, it would be the first mRNA seasonal flu vaccine in the US.
Moderna is seeking standard approval for the 50-64 age group and accelerated approval for individuals 65 and above. Meanwhile, the company appointed Ester Banque as Chief Commercial Officer to oversee preparations for three possible product launches between 2027 and 2028. A successful approval would make mFlusiva the first mRNA-based seasonal flu vaccine in America. The VRBPAC vote and subsequent FDA ruling will determine its availability. Moderna’s stock surge reflects investor confidence in the vaccine’s prospects.