Topline
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.
Moderna said its mFLUSIVA shot will be available for eligible populations for the 2026-2027 flu season.
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Key Facts
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.
Crucial Quote
“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.
What Do We Know About The FDA’s Earlier Stance?
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.”
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