The Food and Drug Administration’s vaccine advisory panel has approved Moderna’s new flu vaccine, mFlusiva (mRNA-1010), for older adults. The committee overwhelmingly backed the vaccine for two age brackets: adults aged 50 to 64 and those 65 years and older.
Both votes were 9-0 in favor of approving the mRNA-based jab. During a daylong meeting, panelists discussed the vaccine’s efficacy and safety data, existing influenza vaccination options, and the current flu landscape in the U.S. Several presenters noted that an mRNA option could enable faster production, helping officials better match each year’s vaccine to circulating strains.
In Moderna’s presentation, Rituparna Das, M.D., Ph.D., SVP of clinical development in infectious and rare diseases at the company, stated: “Current influenza vaccine technologies can be affected by the long interval between strain selection and vaccination. By directly encoding the selected antigen sequence, avoiding egg adaptation and supporting a more flexible manufacturing timeline, mRNA-1010 has the potential to address important limitations of current influenza vaccines and improve protection in a population that continues to experience substantial influenza disease burden.”
Brownstone Institute President Jeffrey Tucker remarked the approval was driven by “profits.” Moderna is not the only company recently granted approvals for its products; according to reports, the Centers for Disease Control and Prevention (CDC) awarded Pfizer $1.24 billion for COVID-19 jabs.
FDA vaccine reviewer Dr. Timothy Brennan suggested the agency might approve the vaccine for older adults ahead of the coming flu season despite needing more information on its use in frail seniors or individuals with weak immune systems.
If approved, Moderna plans a study involving 400,000 people aged 65 and older, with half receiving the mRNA vaccine and the other half a standard senior flu shot. The trial will be repeated for two flu seasons.
Moderna’s data showed no major safety issues, though the shot caused temporary reactions including injection-site pain, fever, headache, tiredness, and aches—reactions more common than those from current flu shots but typical of mRNA vaccines. Dr. Hayley Gans, a Stanford Medicine pediatrician and FDA adviser, explained such reactions can signal “your immune system is responding,” emphasizing the need to communicate this to vaccine recipients.
Earlier this year, Moderna’s data was at the center of a public dispute when a then-top FDA official blocked the company’s application for its first mRNA flu shot. The embattled vaccine chief at the time, Dr. Vinay Prasad, stated the company should have compared its shot to a high-dose flu vaccine recommended for seniors rather than a standard-dose brand. He noted this reflected heightened FDA scrutiny under Health Secretary Robert F. Kennedy Jr.
