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Today, the US Food and Drug Administration announces a virtual meeting in its Advisory Committee on Vaccines and Related Biological Products (VRBPAC) on 15 February to discuss the Pfizer-BioNTech COVID-19 vaccine for emergency use in children aged 6 months to 4 years.

“Having a safe and effective vaccine available to children in this age group is a priority for the Agency, and we are committed to a timely review of the data that the Agency asked Pfizer to submit in the light of the recent Omicron increase. In addition, children are “Because they are still growing and evolving, it is crucial that these vaccines are evaluated in well-designed and well-conducted clinical trials,” said Acting FDA Commissioner Janet Woodcock, MD. “Meanwhile, the best way to protect children, including when in school or day care, must practice social distancing and masking in accordance with public health recommendations, and for their family members and caregivers to be vaccinated or receive a booster dose when justified. “

FDA approved Pfizer-BioNTech COVID-19 vaccine for use in children 5 to 11 years of age October 2021 and has recently approved the use of a single booster dose for people aged 12 to 15 years and older. From 19 December 2021 according to Center for Disease Control and Prevention (CDC), 8.7 million COVID-19 vaccinations have been given to children aged 5 to 11 years, which is about one-third of the approximately 24 million American children of this age in the United States. There are approximately 18 million children under the age of 5 in the United States

“The need for a safe and effective vaccine for our youngest children is significant, especially in light of the rapid spread of the omicron variant, the remarkable increase in the number of admissions in young children with severe disease and the possibility that future variants may cause serious disease in those who are unvaccinated, “said Peter Marks, MD, Ph.D., director of the FDA’s Center for Biological Evaluation and Research.” As we have done for other COVID-19 vaccine approvals, this meeting will help ensure , that the public has a clear understanding of the data and information that the FDA will evaluate when considering whether the vaccine should be approved. We are committed to a transparent process that will include input from our external advisors. ”

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

In general, the advisory committees include a chairperson, 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 channel; The meeting will also be webcasted from the FDA’s website.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.