AP source: US urges Pfizer to apply for under-5 COVID shots

Feb 01, 20220

PAUL RATJE, New York Times count

Mila Pagador, 5, speaks to registered nurse Ashley Bean before she receives her dose of the Pfizer-BioNTech COVID-19 vaccine in Albuquerque, N.M., Nov. 10, 2021. Pfizer and its partner BioNTech are expected as soon as Tuesday, Feb. 1, 2022, to ask the Food and Drug Administration to authorize a coronavirus vaccine for children 6 months to 4 years old as a two-dose regimen while they continue to research how well three doses work.

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.

https://www.startribune.com/ap-source-us-urges-pfizer-to-apply-for-under-5-covid-shots/600141698/