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FDA Approves Updated Covid Vaccines, Limits Eligibility to Seniors and High-Risk Groups

Practical access remains uncertain pending insurer decisions, pharmacy rules, CDC guidance.

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.
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MIAMI, FLORIDA - MAY 29: In this photo illustration, Ruth Jones, Immunization Nurse, holds a Pfizer-BioNTech COVID-19 vaccine (brand name: Comirnaty) at Borinquen Health Care Center on May 29, 2025 in Miami, Florida. Health Secretary Robert F. Kennedy Jr. announced that he will no longer recommend that healthy children and pregnant people get COVID-19 shots. (Photo illustration by Joe Raedle/Getty Images)

Overview

  • The FDA cleared new shots from Pfizer, Moderna and Novavax for broad use in adults 65 and older, with access for younger adults and children restricted to those with at least one qualifying medical condition.
  • Pfizer’s authorization for children under 5 was revoked, leaving no vaccine for healthy kids in that age group; Moderna remains available from 6 months for children with serious health problems, and Novavax is limited to high-risk patients 12 and up.
  • Manufacturers say distribution begins within days for Pfizer and Moderna and in early fall for Novavax, with the formulations targeting the LP.8.1 subtype and related strains.
  • Coverage and logistics are unresolved as insurers weigh benefits, some states limit pharmacists to CDC‑endorsed vaccines, and patients under 65 may need to document high‑risk status or face out‑of‑pocket costs that could exceed $150.
  • A new CDC advisory panel is expected to meet in September to issue recommendations that will guide coverage and pharmacy access, while major pediatric groups such as the American Academy of Pediatrics continue to back broader vaccination for young children.