The FDA may limit the availability of pediatric COVID-19 vaccines this fall as it considers whether to renew the emergency green light for the Pfizer-BioNTech vaccine. The company has asked to keep the current authorization for kids under 5 years in place, but the regulator is weighing its options.
Pfizer’s pediatric vaccine faces a uncertain future due to ongoing discussions with the FDA about its approval status. The company claims that any changes will not affect the safety and efficacy of the vaccine. However, Moderna is working closely with the CDC to increase supplies of its mRNA-based shot for COVID prevention in kids.
The potential change coincides with recent actions by Robert F. Kennedy Jr.’s HHS, which has sparked concerns about growing anti-vaccine sentiment within the federal health apparatus. The FDA has proposed a new “evidence-based approach” to COVID-19 vaccination, and the CDC has revised its vaccine recommendations for pregnant women and healthy children.
If the FDA decides not to renew Pfizer’s pediatric EUA, the options for young kids will be limited, with Moderna’s and Novavax’s vaccines being more restricted.
Source: https://www.fiercepharma.com/pharma/fda-may-not-renew-pfizers-pediatric-covid-shot-authorization-prompting-potential