AP source: US urges Pfizer to apply for under-5 COVID shots
February 1, 2022
WASHINGTON - U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February, a person familiar with the matter told the Associated Press Monday.
The company's application was expected to be submitted as soon as Tuesday.
Early Pfizer data has shown the vaccine - which is administered to younger kids at one-tenth the strength of the adult shot - is safe and produces an immune response. But last year Pfizer announced the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5, and regulators encouraged the company to add a third dose to the study on the belief that another dose would boost the vaccine's effectiveness much like booster doses do in adults.