FDA Authorizes Pfizer’s COVID-19 Vaccine for 12- to 15-Year-Olds; US Now Waiting for ACIP Approval

upstart writes in with an IRC submission:

FDA authorizes Pfizer's COVID-19 vaccine for 12- to 15-year-olds:

The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening.

[...] The authorization of the Pfizer-BioNTech vaccine for the adolescent group was widely expected. It follows an announcement from the two companies on March 31 which declared that the vaccine completely protected 12- to 15-year-olds against COVID-19 in a small Phase III clinical trial involving 2,260-adolescents.

[...] In the trial, 1,131 adolescents received the vaccine while the other 1,129 received a placebo. The FDA focused on those who had no evidence of being infected by the pandemic coronavirus prior to the trial, leaving the agency with 1,005 vaccinated adolescents and 978 adolescents given a placebo. The FDA reported 16 cases in the trial, all of them in the placebo group. "The vaccine was 100% effective in preventing COVID-19," the agency announced. Moreover, in a smaller sampling, those in the vaccinated group appeared to produce neutralizing antibodies at higher levels than those seen earlier in people ages 16 to 25, Pfizer noted in March.

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