Moderna mRNA flu vaccine approved by FDA; postmarket studies required; pediatric deferral; HHS claims ACIP cannot meet for flu season; adjuvanted flu modeling for 50-64; practical guidance not to wait; access barriers even after FDA approval; flu vaccine likely fine via workarounds; same-day coadministration safety data; high-dose flu vaccine reduces hospitalizations by 38.5% in 65+; new study confirms adjuvanted and high-dose equally protective; CSL Seqirus ships first flu vaccines for 2026/27; practical pharmacy preparation checklist published; Navy reinstates flu vaccination requirements for sailors; insurers covering through 2027; new controversy: FDA data reanalysis sent to RFK Jr. claims Moderna mRNA flu shot should be withdrawn
Key Questions
What progress has Moderna's mRNA flu vaccine made?
VRBPAC unanimously recommended mFlusiva for adults 50+ (full) and 65+ (accelerated) on June 18. Final FDA decision is set for August 5 with no serious safety concerns identified.
How are access barriers affecting flu vaccines this season?
ACIP paralysis means no recommendation for the mRNA flu vaccine, so Medicaid and private insurers may not cover it. Workarounds are being explored but practical pharmacy access remains uncertain.
What effectiveness data supports enhanced flu vaccines?
High-dose flu vaccine reduces hospitalizations by 38.5% in 65+, and adjuvanted and high-dose options show equal protection. Current vaccines are advised for 50+ adults without waiting for mRNA versions.
Moderna mRNA flu vaccine (mFlusiva) FDA approved on Aug 5 for adults 50+; 26.6% relative efficacy vs standard vaccine for 50-64 (absolute risk reduction ~0.73 percentage points), accelerated approval for 65+ based on antibody bridging, and an unusual FDA internal dispute. Postmarket efficacy studies required; pediatric deferral. New controversy: FDA data reanalysis sent to RFK Jr. claims Moderna mRNA flu shot should be withdrawn, citing risk-benefit imbalance. HHS claims ACIP cannot meet for flu season, creating access barriers. Navy announces new flu vaccination requirements. Practical guidance: adults 50+ should not wait; current vaccines effective. New meta-analysis confirms high-dose flu vaccine reduces influenza-related hospitalizations by 38.5% in 65+. CSL Seqirus ships first flu vaccines for 2026/27 season. A recent analysis from a pharma perspective reinforces the conditional approval and phase IV requirements for seniors, highlighting access barriers and evidence gaps. Consumer media coverage is emerging, emphasizing the new option for older adults and the political backdrop (HHS spokesperson comments, BARDA cuts). A New York doctor explains the new mRNA flu vaccine option and practical rollout delays for adults 50+. A Medpage Today synthesis confirms insurers covering vaccines through 2027, providing practical clarity for fall vaccination decisions. ACIP still hasn't met, leaving fall flu shot recommendations in limbo. Key reassurance from Schaffner: insurers will cover and professional societies are recommending; new mRNA flu shot is coming but not yet widely available.