Moderna's mRNA flu shot moves to FDA review after dispute resolution
Moderna says the FDA will review its experimental mRNA-based flu vaccine after resolving a public dispute, signaling movement toward potential regulatory consideration of the shot.
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Flu Vaccine
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FDA reopens review of Moderna’s mRNA flu shot ahead of fall rollout
The FDA has agreed to review Moderna’s experimental mRNA flu vaccine after previously declining to file, with a decision due by August 5; Moderna seeks full approval for adults 50–64 and accelerated approval for 65+, contingent on a post‑marketing study, amid broader regulatory shifts and debate over vaccine oversight.
FDA to Revisit Moderna’s New mRNA Flu Vaccine for Adults 50+
The FDA will review Moderna’s newly developed mRNA seasonal flu vaccine after a prior rejection over trial design, with no safety or efficacy concerns cited. Moderna says it has met with the FDA and proposed a revised regulatory pathway, seeking full approval for adults 50–64 and accelerated approval for 65+, potentially making the vaccine available for those 50+ in the 2026–2027 flu season if approved.
FDA Reverses Course, Will Review Moderna’s mRNA Flu Vaccine for Adults 50+
The FDA reversed its earlier decision and will review Moderna’s new mRNA flu vaccine for adults 50 and older, using a standard pathway for ages 50–64 and accelerated approval for those 65+, with a required post‑marketing study and a target review date of August 5.
FDA showdown over Moderna flu shot sparks fears of anti-vaccine bias
The FDA declined to review Moderna’s experimental mRNA flu vaccine, citing an allegedly inadequate trial design for adults 65 and older that used a standard-dose control instead of a high-dose option, prompting critics to allege an anti-vaccine agenda and a chilling effect on vaccine development; Moderna and its supporters argue the design was approved and that higher-dose controls should have informed the analysis.
RFK Jr.'s Vaccine Messaging Tied to Dip in Kids' Flu Shots
Childhood flu vaccine uptake fell 1.5 percentage points nationally as of Jan. 3, continuing a multi-year decline, amid a Kennedy-era overhaul of federal vaccine guidance that urges parents to consult doctors before vaccinating, drawing criticism from medical groups.
Virginia records first pediatric flu death of the season, vaccines urged
A preschool-age child in Virginia died from flu-related complications, the state’s first pediatric flu death this season. The Virginia Department of Health notes ongoing flu activity and low vaccination rates, urges eligible residents to get vaccinated, and highlights the presence of a highly contagious H3N2 subclade (subclade K) while vaccines remain protective against severe illness.
U.S. Simplifies Childhood Vaccine Schedule, Reducing Shots and Diseases Covered
The US has revised its childhood vaccine schedule, now recommending fewer vaccines for flu, hepatitis A and B, and RSV, aligning with peer countries, and bypassing the usual approval process, under Health Secretary Robert F. Kennedy Jr.'s initiatives.
US Flu Surge: 11 Million Cases, Rising Hospitalizations, and Widespread Impact
The CDC reports that flu activity in the U.S. has reached its highest level on record, with a significant rise in hospitalizations and cases, especially among children and young adults, driven by a new H3N2 subclade K strain. Despite the severity, vaccination rates remain low, and health officials warn that the peak of the flu season has not yet been reached, with ongoing circulation of COVID-19 and RSV.
Colorado's Flu Surge Reaches 20-Year High Amid Holiday Season
Colorado is experiencing a severe flu season with rising hospitalizations, especially among children, partly due to a less effective vaccine match and a new aggressive strain. Despite some underreporting, data shows a significant increase in flu activity, and the flu currently poses a greater risk than COVID, emphasizing the importance of vaccination and preventive measures.
Colorado Faces Record-Breaking Flu Hospitalizations in 2025
Flu hospitalizations in Colorado have surged to the highest level in over 20 years, driven by a new variant called subclade K and lower vaccination rates, with cases expected to rise further in the coming weeks.
NC hospitals tighten visitor policies amid surge in flu and respiratory illnesses
Flu cases in North Carolina are surging earlier and more sharply this season, driven by the efficient spread of the subclade K variant, leading to increased hospitalizations and emphasizing the importance of vaccination and preventive measures.
Minnesota Faces Surge in Flu and Respiratory Illnesses This Holiday Season
Flu cases are surging in Minnesota, with nearly 2,000 cases reported in December and more expected during the holidays, prompting health officials to recommend vaccination, masks, and avoiding social gatherings if symptomatic, especially for vulnerable populations like children and seniors.
US Faces Surge in 'Super Flu' Cases Across Multiple States
A new 'super flu' strain, not covered by this year's flu vaccine, is spreading across the US, especially in New York, Louisiana, and Colorado, leading to increased hospitalizations. Symptoms include fever, chills, cough, sore throat, and muscle aches, with some cases resulting in severe complications like pneumonia. Experts recommend getting the flu shot despite its limited coverage, as it can help reduce symptoms.
Government Shutdown Threatens Flu Tracking and Preparedness
The article discusses how reduced global influenza sample sharing, partly due to the US withdrawal from WHO, is impairing flu virus tracking and vaccine development, potentially leading to less effective flu shots and decreased pandemic preparedness.