BREAKING—U.S. FDA has just expanded the emergency use authorization (EUA) for the Pfizer-BioNTech #COVIDVaccine to include adolescents 12 through 15 years of age. #COVID19
fda.gov/news-events/pr…
fda.gov/news-events/pr…
2) “The 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,”
3) “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.
4) “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…
5) “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.
6) “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.
7) Last week, Canada approved the Pfizer vaccine for kids 12+ google.com/amp/s/beta.ctv…
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