FDA may revoke Pfizer COVID-19 vaccine authorization for kids under certain age

Core Viewpoint - The U.S. FDA may not renew the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine for children under five, potentially removing the only available vaccine for this age group from the market [1][2]. Group 1: Regulatory Developments - Pfizer is in discussions with the FDA to keep the EUA for children under five in place for the 2025-2026 season, emphasizing that these discussions are unrelated to the vaccine's safety and efficacy [2]. - The CDC has updated its immunization schedule, allowing Moderna shots for moderately or severely immunocompromised children aged 6 months to 4 years, while different recommendations apply for older age groups [5]. - The HHS stated that the COVID-19 pandemic officially ended with the expiration of the federal public health emergency in May 2023, and any future regulatory changes should be regarded as speculation until officially announced [6]. Group 2: Public Health Implications - The removal of the COVID vaccine recommendation for healthy children and pregnant women has been noted, with a focus on restoring public trust in health agencies [7][9]. - The executive director of the American Public Health Association highlighted that the low vaccination rates would still be impacted by the potential removal of the vaccine for young children [9][10].