Pfizer asks for U.S. authorization of COVID shots for kids under 5
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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 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.
"Having a safe and effective vaccine available for children in this age group is a priority," Acting FDA Commissioner Janet Woodcock said. She said the agency asked for the application because of the recent Omicron surge.
If the FDA authorizes the vaccine after its advisory panel meeting, the U.S. Center for Disease Control and Prevention also needs to sign off on how the vaccinations will be implemented, following a meeting of its own advisers. Those meetings have tended to follow within a week or so of FDA decisions.