KONTAN.CO.ID - WASHINGTON. Pfizer Inc and BioNTech SE on Tuesday said they have begun submitting data to U.S. regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5, despite weaker than expected immune responses in their clinical trial of 2- to 4-year-olds. The companies said they started the rolling submission of the data following a request from the U.S. Food and Drug Administration in order to address an urgent public health need in the age group. The FDA said an outside committee of expert advisers would meet on Feb. 15 to discuss the authorization.
Pfizer Asks for U.S. Authorization of COVID Shots for Kids Under 5
KONTAN.CO.ID - WASHINGTON. Pfizer Inc and BioNTech SE on Tuesday said they have begun submitting data to U.S. regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5, despite weaker than expected immune responses in their clinical trial of 2- to 4-year-olds. The companies said they started the rolling submission of the data following a request from the U.S. Food and Drug Administration in order to address an urgent public health need in the age group. The FDA said an outside committee of expert advisers would meet on Feb. 15 to discuss the authorization.