FDA advisory panel backs Moderna's mRNA flu vaccine for adults 50+
The FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended Moderna's mRNA influenza vaccine, mFlusiva, for adults aged 50 and older, citing no major safety concerns and potential efficacy advantages.
The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend Moderna's mRNA influenza vaccine, mFlusiva, for adults 50 years and older. The panel’s recommendation follows a review that found no major safety issues and suggested the vaccine could provide stronger and broader protection than traditional flu shots.
The committee, meeting for the first time since 2023 to evaluate a new vaccine, heard testimony from CDC, FDA and Moderna officials. CDC epidemiologist Dr. Lisa Grohskopf noted that the most recent flu season recorded roughly 32 million cases, 390 000 hospitalizations and 24 000 deaths in the United States, with about 85 % of those eligible for vaccination not fully vaccinated.
Moderna’s vice president of epidemiology, Dr. Evan Anderson, said the mRNA platform could shorten the time needed to produce a strain-matched vaccine from six months to two-to-three months, potentially improving efficacy. FDA medical officer Dr. Gauri Raval added that the vaccine may offer greater efficacy than the standard-dose comparator in preventing severe influenza-associated illness.
Phase-3 trial data published in peer-reviewed journals showed a longer-lasting immune response and antibodies that recognized a broader range of flu strains. "There were no shortcuts taken. There was a full efficacy evaluation done per standard FDA guidance," said Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University and VRBPAC member.
Former FDA Center for Biologics Evaluation and Research director Dr. Jesse Goodman emphasized that concerns about mRNA vaccines altering DNA have been disproven, citing over 6 billion doses administered since 2020 with an excellent safety record.
The advisory panel’s nine members all voted in favor of the vaccine after a six-and-a-half-hour meeting. The FDA has not yet issued a final decision, but if approved, Moderna expects the vaccine could be available for the upcoming flu season.