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FDA, Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

February 01, 2022, The U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials,” said Acting FDA Commissioner Janet Woodcock, M.D. "In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caretakers to get vaccinated or receive a booster dose when eligible.” The FDA authorized the Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age in October 2021 and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older. As of Dec. 19, 2021, according the Centers for Disease Control and Prevention (CDC), 8.7 million COVID-19 vaccinations have been given to kids 5 through 11 years of age, which is about one-third of the approximately 24 million U.S. kids this age in the U.S. There are approximately 23 million children less than 5 years of age in the U.S.

“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “As we have done for other COVID-19 vaccine authorizations, this meeting will help ensure that the public has a clear understanding of the data and information the FDA will evaluate as it considers whether to authorize the vaccine. We are committed to a transparent process, which will include input from our external advisors.”

The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

In general, advisory committees include a Chair, members with scientific, medical and public health expertise and a consumer and industry representative.

The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube channelExternal Link Disclaimer; the meeting will also be webcast from the FDA website.



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