Moderna's mRNA-1010 Vaccine Receives Unanimous Support from FDA Advisory Committee
Moderna announced that the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee voted 9-0 that the benefits of mRNA-1010, Moderna's investigational seasonal influenza vaccine, outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age and voted 9-0 that the benefits of mRNA-1010 outweigh its risks for the prevention of influenza disease in adults 65 years of age and older. "The FDA will consider the recommendations of VRBPAC as part of its ongoing review of Moderna's Biologics License Application for mRNA-1010. Advisory committee recommendations are non-binding, and the FDA is responsible for making the final approval decision. mRNA-1010 has been accepted for regulatory review in the United States, European Union, Canada and Australia. Moderna has received a U.S. FDA Prescription Drug User Fee Act goal date of August 5, 2026. Regulatory submissions in additional countries are planned during 2026," the company stated. "We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010. Influenza continues to cause substantial illness and hospitalizations among older adults each year. We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review," said Stephane Bancel, Chief Executive Officer of Moderna.
