The U.S. Food and Drug Administration will review Moderna’s mRNA 1010 flu vaccine for older adults, which could make it available ahead of the traditional cold and flu season at the end of 2026, the drugmaker announced on Wednesday. File Photo by Debbie Hill/UPI | License Photo
Moderna’s mRNA-1010 flu vaccine for older adults could be made available by the end of 2026, the pharmaceutical company announced Wednesday.
Officials at the Food and Drug Administration have agreed to undertake a review of Moderna’s seasonal influenza vaccine.
Moderna and FDA officials recently met to discuss the vaccine’s review with the goal date of Aug. 5.
“Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu,” Moderna Chief Executive Officer Stephane Bancel said.
The mRNA-1010 vaccine is undergoing review in Europe, Australia and Canada, and the U.S. review could make it available here in time for the annual arrival of the fall cold and flu season.
The vaccine is intended for older adults who are age 50 and over, which is the age group for which Moderna officials recommended the FDA undertake its review of the mRNA-1010 vaccine.
Although the initial FDA review could make the vaccine available ahead of the next flu season, ongoing regulatory reviews would continue to ensure the vaccine’s efficacy.
The announced review comes after the U.S. Department of Health and Human Services in August nullified many contracts with drugmakers who were working on mRNA-based vaccines for respiratory viruses.
Department Secretary Robert F. Kennedy Jr. on Aug. 5 announced it was canceling 22 contracts totaling $500 million after government officials decided the mRNA technology creates more risks than benefits for treating respiratory viruses.
“HHS supports safe, effective vaccines for every American who wants them,” Kennedy said in August. “That’s why we’re moving beyond the limitations of mRNA for respiratory viruses and investing in better solutions.”
The mRNA technology enabled the rapid development of COVID-19 vaccines that largely are credited with ending the recent pandemic, but the quick approvals raised concerns regarding their effectiveness.
The ongoing studies for the mRNA-1010 vaccine would help to assuage such concerns.
