FDA Grants First Approval for mRNA Flu Vaccine Targeted at Seniors

The U.S. Food and Drug Administration approved Moderna's mRNA flu vaccine for adults 65 years and older, the first mRNA influenza shot cleared for use in the United States. The decision follows a prior request for review that was declined earlier in the year. > "Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform," Moderna chief executive Stéphane Bancel said. The agency said the vaccine met safety and efficacy standards required for licensure. The approval comes after the FDA previously cited concerns about the control vaccine used in the trial, but later indicated the review process was part of routine discussions with manufacturers. The new product is expected to be available later this year pending distribution arrangements.