On August 5, 2026, Moderna announced that the FDA approved mFLUSIVA (mRNA-1010), a new seasonal influenza vaccine, for use in all adults 50 years of age and older. As we previously reported, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s mRNA-1010 outweigh its risks for adults ages 50 to 64 and adults ages 65 and older.
mRNA-1010 has been accepted for regulatory review in the European Union, Canada, and Australia. According to Moderna, regulatory submissions in additional countries are planned during 2026.