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FDA Clears Updated Pfizer COVID Vaccine, Limits Routine Use to Seniors and High-Risk Patients

Availability will depend on insurer, pharmacy, state decisions.

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)
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Overview

  • The FDA approved Pfizer’s updated COVID-19 shot for the coming season.
  • Use is unrestricted for adults 65 and older, while younger adults and children qualify only with a high-risk condition such as asthma or obesity.
  • Doses begin shipping immediately, with access contingent on decisions by federal health advisers, private insurers, pharmacies and state authorities.
  • The American Academy of Pediatrics objected to the limits, warning they could block families seeking vaccination for children.
  • The policy shift reflects skepticism from Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, as local data show cases rising and a 'stratus' strain circulating in parts of the West and South.