Pfizer, Moderna Ask US Regulators for Emergency Authorization for New Boosters for Children
Pfizer and Moderna have formally asked U.S. regulators to grant emergency authorization for new COVID-19 vaccine boosters for children as young as five.
Pfizer and its partner BioNTech submitted a request to the U.S. Food and Drug Administration (FDA) on Sept. 26, several days after Moderna submitted a request to the FDA.
The FDA authorized bivalent boosters from the companies, containing components of the Wuhan virus strain and a BA.4/BA.5 spike protein, on Aug. 31—the first time the formulations have been updated.
BA.5 is the dominant strain in the United States at present.
No human data are available for the updated boosters, including for children….