Silver Spring, MD – The U.S. Food and Drug Administration has announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 15th, 2022 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.
“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,” Woodcock stated.
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 December 19th, 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 United States kids this age in the U.S. There are approximately 18 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,” Marks stated.
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.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.