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COVID-19 Vaccine for Emergency Use in Adolescents

COVID-19 Vaccine for Emergency Use in Adolescents
As per new rules Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.From March 1, 2020 through April 30, 2021, 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 COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.
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The effectiveness data to support the EUA in adolescents down to 12 years of age is based on immunogenicity and an analysis of COVID-19 cases. The immune response to the vaccine in 190 participants, 12 through 15 years of age, was compared to the immune response of 170 participants, 16 through 25 years of age. In this analysis, the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants. An analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was also conducted. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19. At this time, there are limited data to address whether the vaccine can prevent transmission of the virus from person to person. In addition, at this time, data are not available to determine how long the vaccine will provide protection.This is proper estimate for USA peoples.

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