Article Summary:
The FDA is considering not renewing the emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine for children aged 6 months to 4 years in the US. This could potentially diminish the ability to inoculate young children against COVID-19 this fall. Pfizer has communicated with the FDA about a path forward for its pediatric vaccine and has requested that the EUA for the under-5 age group remain in place for the 2025-26 season.
The FDA has assured that these deliberations are not related to the safety and efficacy of the vaccine, which continues to demonstrate a favorable profile. In response to the potential change, Moderna is reportedly working with the CDC to increase the supply of its own mRNA-based COVID-19 vaccine for pediatric use. The CDC is in discussions with Moderna to rapidly scale up the pediatric vaccine supply, addressing considerations like volume, shipment timing, and potential supply gaps.
Moderna’s COVID-19 vaccine is currently approved for use in people aged 6 months to 64 years with certain underlying health conditions, as well as in all individuals aged 65 and older. In contrast, Pfizer’s pediatric EUA does not have the same stipulation concerning recipients’ underlying health conditions.
The Department of Health and Human Services, which oversees the FDA, has stated that the COVID-19 public health emergency ended in May 2023, and they do not comment on potential future regulatory changes, treating such discussions as speculation until officially announced.