A federal advisory panel has endorsed Moderna's mRNA-based seasonal influenza vaccine, clearing a key hurdle toward potential approval. The vote from the Vaccines and Related Biological Products Advisory Committee came after months of debate over the shot's efficacy and safety profile.
The recommendation carries significant weight for both Moderna and the broader mRNA vaccine landscape. The company has been seeking to expand its platform beyond COVID-19, and a green light for its flu vaccine could open a major new revenue stream.
Earlier this year, the vaccine became the subject of controversy, though the advisory panel ultimately found its benefits outweighed its risks. The FDA typically follows its advisers' recommendations but is not bound to do so.
If approved, Moderna would compete in a flu vaccine market dominated by Sanofi and CSL Seqirus. An mRNA flu shot could also offer manufacturing advantages, allowing faster adaptation to circulating strains.
Critics have questioned the durability of protection from mRNA flu shots compared with traditional formulations. The FDA will make a final decision in the coming months.