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U.S. considers authorization of first COVID vaccine for children under 5


U.S. regulators are considering the first COVID-19 vaccine for children under the age of 5, the only age group not yet eligible for the shots, after Pfizer Inc (PFE.N) and BioNTech SE began the regulatory approval process on Tuesday. A decision is expected as soon as this month. The companies said they began submitting data for an emergency use authorization even though they did not meet a key target in their clinical trial of 2- to 4- year olds. They are submitting the data at the request of the U.S. Food and Drug Administration in order to address an urgent public health need in the age group, they said.

Reuters - February 2, 2022

View the full story here: https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-submits-data-seeking-us-approval-covid-vaccine-young-kids-bloomberg-2022-02-01/