“What we're dealing with is taking the approach that we should take, as a public health agency, is taking the data coming into us and constantly adjusting to the data.”
Dr. Peter Marks, director for the FDA's Center for Biologics, on postponing further evaluation of the Pfizer COVID-19 vaccine for children under 5.
feb 11, 2022
- Pfizer was applying for emergency use authorization for its COVID vaccine for those 6 months - under 5 years old; Pfizer has an EUA for those 5 and older, and approval for their vaccine for those 16 and older.
- The FDA had encouraged this application, citing the higher levels of infections/hospitalizations for younger children with Omicron.
- However, Pfizer previously raised concerns about the efficacy of the vaccine in those 2-4 years old and launched a new study with a third dose (the previous study only tested 2 doses).
- This current delay comes from both Pfizer and the FDA agreeing that more time is needed to collect data on this group receiving 3 doses.
Why It Matters: The postponement delays the potential to consider an EUA for this vaccine until at least April.
FDA: Pfizer delays COVID vaccine EUA submission for younger children, more data needed