The US Food and Drug Administration (FDA) is considering revoking its approval of Pfizer’s COVID-19 vaccine for healthy children under the age of 5, according to the company. This move could leave many young kids without access to a COVID-19 shot.
If authorized, Moderna’s vaccine will remain an option for those at increased risk of severe illness due to underlying conditions. The decision is part of a series of changes in immunization policy made by US health agencies since Robert F. Kennedy Jr., the new Health and Human Services Secretary, took office.
Pfizer has expressed concerns that the FDA’s consideration may be unrelated to vaccine safety and efficacy, which have shown favorable profiles. Moderna is working with the Centers for Disease Control and Prevention (CDC) to increase supplies of its COVID-19 shot for children.
In recent months, Kennedy has targeted these vaccines, filing a petition in 2021 demanding revocation of authorization. The CDC previously recommended COVID-19 vaccines for healthy children but later clarified that they may be given to those kids if a doctor agreed it was necessary.
Source: https://www.cnbc.com/2025/08/12/fda-may-pull-authorization-of-pfizer-covid-shot-for-children-under-5.html