FDA Approves First mRNA Flu Vaccine For Older Adults
The U.S. Food and Drug Administration approved the country’s first mRNA-based flu vaccine for older adults, months after the regulator faced backlash from medical professionals and scientists for refusing to review the shot amid a broader effort by the Robert F. Kennedy Jr. led health department to crack down on mRNA shots.
In a statement, vaccine maker Moderna said its “mFLUSIVA” vaccine against seasonal influenza has been approved for use by all adults aged 50 and older.
The approval was based on a phase 3 trial involving nearly 41,000 people aged between 50-64 years, which found that the mRNA vaccine is around 26.6% more effective in preventing a flu infection compared to older flu shots.
In June, the FDA’s independent vaccine advisory committee unanimously recommended the approval of the vaccine for adults aged between 50 and 64.
The FDA has also granted accelerated approval for administering the vaccine to adults who are 65 and older, based on the panel’s recommendation—which could become a full approval if follow-up trial results are considered favorable.
Moderna said it expects mFLUSIVA to be available to eligible populations in the country for the 2026-2027 flu season.
"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 CEO Stéphane Bancel said.
In February, Moderna announced that the FDA had rejected its request to review its mRNA flu vaccine. The drugmaker noted that the FDA’s top vaccine regulator, Dr. Vinay Prasad, dismissed the company’s application over its choice of the control flu vaccine the mRNA shot was compared against, which it didn’t consider the best available vaccine. Prasad is a prominent supporter of Kennedy and has been a critic of the Covid-19 vaccine. After the decision drew backlash, FDA Commissioner Marty Makary walked back the decision and said the initial refusal was “part of a conversation that occurs with all drug makers.”
Last year, Kennedy announced he is canceling contracts and grants worth nearly $500 million earmarked to develop mRNA vaccines. The Health and Human Services department described the decision as a “coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA).” Kennedy, a noted vaccine skeptic who has attacked mRNA COVID-19 vaccines despite pushback from medical professionals and scientists, claimed that data showed the 22 mRNA vaccines being backed by BARDA “fail to protect effectively against upper respiratory infections like COVID and flu.” Kennedy also claimed that the HHS will shift this funding towards “safer, broader vaccine platforms that remain effective even as viruses mutate,” without any specifics. Immunologist and former BARDA Director Rick Bright criticized the decision at the time, saying: “BARDA invested in mRNA technology precisely because it could deliver safe, scalable vaccines in record time, a capability proven during COVID. By dismantling that platform, we’re crippling our front-line defense, just ahead of unknown biological threats.”