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4h ago

FDA Clears Updated Covid Vaccines, Restricting Access to Seniors and High-Risk Patients

Absent CDC guidance, insurance coverage remains uncertain for the fall rollout.

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Four vials with the "Nuvaxovid" COVID-19 vaccine from Novavax are pictured in Saabruecken, Germany, February 26, 2022. REUTERS/Frank Simon/File Photo
Health and Human Services Secretary Robert F. Kennedy Jr. flanked by Director of the National Institutes of Health Jay Bhattacharya, left, and Food and Drug Administration (FDA) Commissioner Marty Makary, right, speaks during a news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025.
Vials of Biontech-Pfizer's Comirnaty vaccine against COVID-19 are seen during vaccination at the Institute for Health and Food Safety of Zenica, Bosnia and Herzegovina, December 16, 2021. REUTERS/Dado Ruvic/File Photo

Overview

  • Pfizer, Moderna and Novavax won FDA approval for 2025–26 formulations, with broad eligibility for adults 65+ and limited use for younger people who have at least one qualifying medical condition.
  • Manufacturer labels differ by age: Moderna is cleared for high-risk patients 6 months–64 and all seniors, Pfizer for high-risk ages 5–64 and all seniors, and Novavax for high-risk ages 12+.
  • The FDA revoked Pfizer’s emergency authorization for children under 5, leaving Moderna as the only option for the youngest kids, and companies say shipments will begin immediately.
  • CDC recommendations are not yet issued and ACIP’s reconstituted panel has no vote scheduled, creating immediate uncertainty over insurer coverage and potential out‑of‑pocket costs that have historically run about $120–$150 per dose.
  • HHS Secretary Robert F. Kennedy Jr. publicly touted the actions—including rescinding remaining EUAs—while major medical groups such as the AAP and ACOG urged broader use for children and pregnant patients, foreshadowing access and implementation challenges for pharmacies and clinics.