The FDA is rapidly reviewing COVID vaccines for children under 12
COVID-19 vaccines for younger children will be vetted as quickly as possible once drugmakers seek authorization for them, U.S. regulators said, vowing a swift review amid concern about the infection risks faced by kids.
Currently, Americans 12 and older are eligible to receive a vaccine. But the recent surge in infections fueled by the Delta variant and the start of a new school year have increased calls for younger children to be immunized.
The Food and Drug Administration is “prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” Janet Woodcock, acting commissioner of the Food and Drug Administration, and Peter Marks, the director of the agency’s Center for Biologics Research and Evaluation, said in a statement on Friday.
“We know there have been questions and public commentary on the process surrounding vaccines for young children, so we think it’s important to share information about the process and the necessary considerations involved to provide greater clarity to the public about this effort,” the officials said.
To date, none of the three companies whose vaccines have been cleared in the U.S. have sought authorization for their use in younger kids. Regulators’ ability to rapidly assess the safety and effectiveness of vaccines for those under age 12 will depend on “the quality and timeliness of the submissions from manufacturers,” Woodcock and Marks said.
President Joe Biden said in a speech at the White House Thursday outlining new measures to curb the pandemic that the government would balance the need to carefully vet a vaccine against the urgent situation created by the recent outbreak.
“We can’t take shortcuts with that scientific work, but I’ve made it clear I will do everything within my power to support the FDA with any resource it needs to continue to do this as safely and as quickly as possible,” he said.
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