FDA Authorizes Pfizer Covid Vaccine For Kids 12 To 15

The U.S. Food and Drug Administration has expanded the emergency use authorization for the Pfizer-BioNTech Covid-19 vaccine to include children ages 12-to-15 years-old.

That expands the Dec. 11, 2020 use authorization for people 16 and older, and at the same dosage. It means a much bigger swathe of the U.S. population can be vaccinated — including middle schoolers before next September rolls around.

The FDA called the expansion “a significant step in the fight against the COVID-19 pandemic.” The agency is holding a press conference at 7 pm ET today that can viewed here.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” said acting FDA Commissioner Janet Woodcock in the eagerly anticipated announcement on Monday afternoon.

From March 1 of last year through April 30 of 201, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder disease course than adults.

The vaccine is administered in two doses, three weeks apart — the same dosage and dosing regimen for 16 years of age and older. The FDA said it made the call when it determined that the “vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.”

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older,” he said.

The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks.

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