Moderna's mRNA-1010, an mRNA-based seasonal influenza vaccine, gained unanimous 9-0 support from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) for use in adults aged 50 and older. This endorsement followed a review of Moderna's Phase III clinical trial data, which showed mRNA-1010 achieved a 26.6% higher relative effectiveness compared to a standard-dose seasonal influenza vaccine in adults aged 50 and older. For those 65 and older, the vaccine also generated a strong protective immune response.
The unanimous vote is a positive turnaround for Moderna, as the FDA had initially refused to accept the application for review in February, citing a lack of a properly conducted study. However, Moderna subsequently submitted a modified application. The FDA has set a PDUFA goal date of August 5, 2026, for a final decision. Moderna is seeking full approval for ages 50-64 and accelerated approval for those 65 and older, which would require an additional post-marketing study.
Analysts have reacted positively to the news. Citi analysts stated that the unanimous vote was a "clear positive and meaningful de-risking event into the PDUFA." William Blair analyst Myles Minter noted that FDA documents revealed "no major deficiencies," boosting confidence in approval. Following the vote, Moderna's shares rose by 3.5% to $63.96 at market open on June 18, up from a close of $61.80. If approved, mRNA-1010 would be the first seasonal influenza mRNA vaccine on the market, potentially improving vaccine effectiveness and strengthening Moderna's position in the post-pandemic vaccine sector.
