[news] FDA Approves Pfizer novel coronavirus vaccine for children aged 12-15

On May 10, the FDA expanded the scope of Pfizer biontech’s novel coronavirus vaccine emergency use authorization to include children aged 12-15

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Available safety data supporting emergency use authorization for adolescents under 12 years of age in the United States include a randomized, placebo-controlled clinical trial conducted in the United States

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A total of 2260 children aged 12 to 15 years were enrolled

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Among them, 1131 children were vaccinated and 1129 received normal saline placebo

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After the second dose, more than half of the subjects were followed up for at least two months

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one    Safety data the most frequently reported adverse reactions (usually lasting 1-3 days) in pediatric clinical trial subjects were pain at the injection site, fatigue, headache, chills, muscle pain, fever and joint pain

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In addition to the pain at the injection site, more adverse reactions were reported after the second injection than after the first injection

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The side effects in child subjects were consistent with those reported by clinical trial subjects aged 16 years and older

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two    The efficacy data compared the immune response to the vaccine in subjects aged 190 to 12 to 15 with that in subjects aged 170 to 16 to 25

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In this analysis, the immune response of adolescents was no worse (at least better) than that of older subjects

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The incidence of novel coronaviruss in subjects aged 12 to 15 years 7 days after the second dose was also analyzed

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In this analysis, there were no new coronal infections among 1005 vaccinators and 16 new coronal infections among 978 placebo vaccinators

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The vaccine is 100% effective in the prevention of cowid-19

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three    Safety testing as part of the original emergency use authorization requirements, Pfizer submitted a plan to continue to monitor the safety of the vaccine

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The program has been updated to include newly authorized children, long-term safety follow-up of subjects in ongoing clinical trials, and other activities aimed at monitoring the safety of pfizer-biontechcovid-19 vaccine and other drugs..

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