Topline<\/p>\n
The U.S. Food and Drug Administration approved the country\u2019s 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.<\/p>\n
Moderna said its mFLUSIVA shot will be available for eligible populations for the 2026-2027 flu season.<\/p>\n
NurPhoto via Getty ImagesKey Facts<\/p>\n
In a statement<\/a>, vaccine maker Moderna said its \u201cmFLUSIVA\u201d vaccine against seasonal influenza has been approved for use by all adults aged 50 and older. <\/p>\n The approval was based on a phase 3 trial<\/a> 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.<\/p>\n In June, the FDA\u2019s independent vaccine advisory committee unanimously<\/a> recommended the approval of the vaccine for adults aged between 50 and 64.<\/p>\n The FDA has also granted accelerated approval for administering the vaccine to adults who are 65 and older, based on the panel\u2019s recommendation\u2014which could become a full approval if follow-up trial results are considered favorable.<\/p>\n Moderna said it expects mFLUSIVA to be available to eligible populations in the country for the 2026-2027 flu season. <\/p>\n Crucial Quote<\/p>\n “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,\u201d Moderna CEO St\u00e9phane Bancel said.<\/p>\n What Do We Know About The FDA\u2019s Earlier Stance?<\/p>\n In February, Moderna announced<\/a> that the FDA had rejected its request to review its mRNA flu vaccine. The drugmaker noted that the FDA\u2019s top vaccine regulator, Dr. Vinay Prasad, dismissed the company\u2019s application over its choice of the control flu vaccine the mRNA shot was compared against, which it didn\u2019t 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<\/a> and said the initial refusal was \u201cpart of a conversation that occurs with all drug makers.\u201d<\/p>\n key background<\/p>\n Last year, Kennedy announced<\/a> 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 \u201ccoordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA).\u201d 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 \u201cfail to protect effectively against upper respiratory infections like COVID and flu.\u201d Kennedy also claimed that the HHS will shift this funding towards \u201csafer, broader vaccine platforms that remain effective even as viruses mutate,\u201d without any specifics. Immunologist and former BARDA Director Rick Bright criticized the decision at the time, saying<\/a>: \u201cBARDA 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\u2019re crippling our front-line defense, just ahead of unknown biological threats.\u201d<\/p>\n further reading<\/p>\n