The U.S. Food and Drug Administration is considering allowing the emergency use authorization for the Pfizer-BioNTech Covid-19 vaccine in children aged six months through four years to lapse ahead of the 2025-26 respiratory virus season, according to company statements and a Centers for Disease Control and Prevention email sent to state immunization programs. If the authorization expires, most healthy children under five would lose access to the only Covid-19 shot broadly cleared for their age group. Moderna’s Spikevax is currently authorized only for young children with underlying medical conditions, and Novavax’s protein-based vaccine is limited to patients aged 12 and older. Pfizer said it is in discussions with the FDA and has asked that the authorization remain in place for at least one more season, emphasizing that the review does not stem from safety or efficacy concerns. Uptake of the pediatric dose has been modest: the CDC estimates just 5.6% of children up to age four received the vaccine during the most recent season. The possible withdrawal follows policy changes announced in May by Health and Human Services Secretary Robert F. Kennedy Jr., who removed routine Covid-19 vaccination from the federal schedule for healthy children and pregnant women. The FDA and HHS have declined to comment on the timing or likelihood of any final decision.
Report suggests FDA may not reauthorize Pfizer COVID vaccine for young kids -CIDRAP
So we are ending access to COVID shots for kids under 5 and cutting funding and support for MRNA technology but maintaining access to desiccated thyroid extract? https://t.co/VHHCxuycFD
BREAKING: The FDA is considering revoking authorization for Pfizer’s COVID-19 vaccine in healthy children under 5.