WASHINGTON — Pfizer Inc. asked U.S. regulators to clear its COVID-19 vaccine for emergency use in children under age 5, an effort to extend protection against the virus to the country’s youngest.
The drugmaker and BioNTech SE finalized their rolling application to the Food and Drug Administration for emergency-use authorization of their vaccine in kids ages 6 months through 4 years old, the companies said in a statement on Wednesday. The vaccine partners began the submission process in February.
Pfizer and BioNTech announced in late May that a three-shot regimen was highly effective and prompted a strong immune response in children under age 5, based on early results from a highly anticipated trial that is likely to pave the way for infants and toddlers to get immunized.
