FDA Approves Moderna's First mRNA Flu Vaccine for Older Adults
The U.S. FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine, for adults aged 50 and older. Clinical trials showed 26.6% greater efficacy than traditional shots. The approval followed a contentious review process, including an initial refusal and subsequent reversal. The vaccine is expected for the 2026-2027 flu season. The decision occurs amid HHS Secretary Robert F. Kennedy Jr.'s efforts to cut federal funding for mRNA vaccine research, including canceling $500 million in contracts.
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5 things to know about Moderna’s new mRNA flu vaccine
The FDA has approved Moderna's new mRNA-based flu vaccine, marking the first mRNA flu shot to receive regulatory clearance. This vaccine, which uses the same technology as Moderna's COVID-19 vaccine, is designed to offer better protection against influenza, particularly for older adults who are more vulnerable to severe illness. The approval comes ahead of the upcoming flu season, and experts believe it could improve vaccine effectiveness and response times to circulating strains. The vaccine is expected to be available soon, with a focus on older populations. This development represents a significant milestone in influenza prevention, leveraging mRNA technology to potentially provide more robust and adaptable immunity compared to traditional flu vaccines.
Moderna’s mRNA flu shot earns FDA approval after rollercoaster review
The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA-based influenza vaccine, marking the first mRNA flu shot to receive regulatory clearance. The approval follows a tumultuous review process, with the vaccine initially facing setbacks and skepticism. The shot is designed to target seasonal flu strains and is expected to be available for the upcoming flu season, particularly for older adults who are at higher risk. The decision is seen as a significant milestone for mRNA technology beyond COVID-19, though some experts caution about efficacy and rollout challenges. The approval comes amid broader debates over vaccine mandates and public health policy, including criticism of past decisions by figures like Robert F. Kennedy Jr. to cancel mRNA vaccine projects.
FDA approves Moderna's mRNA flu vaccine after initial pushback
The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA-based flu vaccine, marking the first time an mRNA flu shot has received regulatory approval. The decision came after an initial refusal-to-file by the FDA, which was later resolved. The vaccine, named mFlusiva, utilizes the same mRNA technology used in Moderna's COVID-19 vaccine. This approval represents a significant expansion of mRNA technology beyond COVID-19 into seasonal influenza prevention. The development is seen as a major step for Moderna and the broader application of mRNA vaccines against respiratory viruses.
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U.S. FDA approves first mRNA flu shot from Moderna
The U.S. Food and Drug Administration has approved Moderna's mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older, marking the first approval of an mRNA vaccine for seasonal flu. The shot received traditional approval for ages 50-64 and accelerated approval for those 65 and older, with Moderna agreeing to conduct additional studies to confirm benefits in the older group. Approval was based on a late-stage trial of over 40,000 adults showing 26.6% greater efficacy than a standard-dose flu vaccine. Moderna also submitted data indicating stronger antibody responses than Sanofi's high-dose vaccine in seniors. The vaccine uses mRNA technology to prompt immune response, potentially allowing faster updates for circulating strains. Analysts do not expect meaningful revenue until late 2027 due to missed contracting cycles. The approval comes amid heightened FDA scrutiny and leadership changes, including the resignation of former Commissioner Marty Makary and vaccine chief Vinay Prasad.
FDA Approves First mRNA Flu Vaccine for Older Adults
The U.S. FDA has approved Moderna's mFLUSIVA, the country's first mRNA-based flu vaccine, for adults aged 50 and older. The approval follows a phase 3 trial of nearly 41,000 people showing the vaccine is 26.6% more effective than traditional flu shots. The FDA also granted accelerated approval for those 65 and older. This decision comes months after the FDA initially refused to review the shot, drawing backlash from medical professionals. The refusal was later walked back by FDA Commissioner Marty Makary. The approval occurs amid broader efforts by HHS Secretary Robert F. Kennedy Jr., a vaccine skeptic, to cut federal funding for mRNA vaccine research, including canceling $500 million in contracts. Moderna expects mFLUSIVA to be available for the 2026-2027 flu season.