![]() ![]() We are confident in the safety, effectiveness and manufacturing data behind this authorization. “The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group. 17, 691 deaths from COVID-19 have been reported in the U.S. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. ![]() The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.” Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock, M.D. “As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization.
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