US EditionFDA commissioner on new COVID-19 vaccine rules: ‘Can’t be blind’
The FDA's narrow vaccine eligibility for 2025-2026 prioritizes adults 65+ and high-risk individuals, overriding staff advice for broader access amid evolving virus concerns.
- On Aug. 27 the U.S. Food and Drug Administration approved new single-dose COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Sanofi/Novavax for the 2025-2026 season and revoked prior emergency use authorizations.
- The agency narrowed eligibility, approving shots only for people 65 and older and younger people with health conditions despite FDA vaccine staff scientists recommending broader access, prompting criticism from lawmakers and state officials.
- The CDC has yet to weigh in, and federal pregnancy guidance conflicts with obstetric groups, while Alaska's Department of Health issues its own bulletins amid varied national recommendations.
- Medicare will cover shots for people 65 and older, and pharmacists may hesitate to vaccinate outside FDA approval due to state limits; doctors can give vaccines off label but uptake is uncertain as some states expand eligibility.
- The Advisory Committee on Immunization Practices will meet September 18 to finalize COVID-19 vaccine recommendations as flu vaccine and nirsevimab for RSV preparations continue, with access varying by state.
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Pharmalittle: We're reading about FDA and Covid shots, a Sanofi setback, and much more
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have cool breezes and much less humidity than recently. Who could ask for anything more? Actually, we could — it is time to reheat the coffee kettle for another cup of stimulation. Our choice today is … orange creme. Sweets for the sweet, as they say. Please feel free to join us. Remember, no prescription is requ…
Alaska Health Department issues Fall vaccine guidance, as FDA updates Covid-19 shot advice
The Alaska Department of Health has released its fall vaccine update, aligning with the latest federal guidance as the state prepares for flu, RSV, and Covid-19 season, but adding that some medical professional groups have developed alternate guidance. Flu VaccineHealth officials recommend that everyone six months and older receive the 2025–2026 trivalent influenza vaccine, which […] The post Alaska Health Department issues Fall vaccine guidance…
What to know about the COVID-19 vaccine this fall
Leer en español What you need to know The FDA approved 2025-2026 COVID-19 vaccines for people 65 and older, and for younger people with certain health conditions that raise their risk of severe illness. The CDC has not yet issued its own recommendations, creating confusion. In the meantime, some states are expanding eligibility and some doctors can choose to give the vaccine off label. Coverage and access vary by state and insurance, so check…
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