FDA may not renew Pfizer’s pediatric COVID-19 shot authorization, creating uncertainty for fall child vaccinations
A report indicates the FDA may not renew the authorization for Pfizer’s pediatric COVID-19 vaccine, which could complicate child vaccination plans for fall 20254.
As of June 25, 2025, the FDA’s webpage still lists Pfizer-BioNTech’s 2024–2025 formula as authorized for ages 6 months through 11 years, suggesting current authorization remains in effect pending any change1.
In May 2025, FDA leaders outlined a new framework indicating future COVID-19 vaccines for healthy people under 65—including infants—would likely require new randomized trials, creating uncertainty for pediatric use of new formulations; however, the framework was said not to affect vaccines already on the market2.
CDC guidance updated June 6, 2025, continues to recommend 2024–2025 COVID-19 vaccination and advises parents of children 6 months–17 years to discuss benefits with healthcare providers, implying pediatric vaccination remains available at present5.
If FDA declines renewal, providers may face a gap for Pfizer pediatric doses this fall until an updated authorization, alternative product (e.g., Moderna), or new data are available; details and timelines have not been formally announced4.
Parents and clinicians should monitor FDA and CDC updates for any authorization changes affecting children 6 months–11 years, as current listings can change quickly during seasonal updates15.
Sources:
1. https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/pfizer-biontech-covid-19-vaccine
2. https://www.statnews.com/2025/05/20/fda-covid-vaccine-recommendations-future-plan-for-infants-worries-pediatricians/
4. https://www.fiercepharma.com/pharma/fda-may-not-renew-pfizers-pediatric-covid-shot-authorization-prompting-potential