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▎The content team editor of WuXi AppTec today, the U.
S.
FDA announced that it has approved the expansion of the new crown vaccine BNT162b2 emergency use authorization (EUA) jointly developed by Pfizer/BioNTech to protect against COVID among adolescents aged 12-15.
-19.
BNT162b2 is a new coronavirus vaccine based on mRNA technology.
Not only does it show 95% preventive efficacy in clinical trials conducted among adults and the elderly, but also over 90% of the protective efficacy produced by vaccination in the real world.
However, this vaccine was only authorized by the FDA for use in people over 16 years of age.
In a phase 3 clinical trial involving 2260 adolescents aged 12-15 years, 18 COVID-19 patients with symptoms were found in the placebo group (n=1129), but none in the vaccine group (n=1131) Symptoms of COVID-19 patients.
Moreover, one month after the second dose of the vaccine, the mean geometric titer (GMT) of neutralizing antibodies elicited by BNT162b2 in this population was 1239.
5, which was non-inferior to the 705.
1 previously achieved in the 16-25-year-old population.
Effectiveness standards.
At the same time, BNT162b2 is well tolerated in this adolescent population, and the side effects are comparable to those previously observed in 16-25 year olds.
This vaccine should not be given to anyone with a known history of severe allergic reactions (including allergic reactions to any component of the vaccine).
"The U.
S.
FDA has extended the emergency use authorization of Pfizer/BioNTech's new crown vaccine to include adolescents aged 12-15.
This is an important step in the fight against the COVID-19 epidemic," said Acting FDA Commissioner Dr.
Janet Woodcock.
"Today's action allows younger The crowd is protected.
Parents and guardians can rest assured that the FDA has conducted a rigorous and thorough review of all existing data.
"Reference: [1] Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic.
Retrieved May 10, 2021, from https://www .
fda.
gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use?utm_medium=email&utm_source=govdelivery Note: This article is for introduction Medical and health research progress is not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.