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Pfizer/BioNTech's COVID-19 Vaccine Shows 100% Efficacy In Late-stage Trial In Adolescents

pfizerbiontech march31 lt

Pfizer Inc. (PFE) and BioNTech's (BNTX) COVID-19 vaccine BNT162b2 has demonstrated 100% efficacy and robust antibody responses in a phase III trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the companies said in a statement.

The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States.

While 18 cases of COVID-19 were observed in the placebo group, there was none in the vaccinated group.

BNT162b2 is authorized or approved for emergency use in individuals 16 years of age and older in several countries around the world including the U.S., U.K., Bahrain, and Canada.

The companies plan to submit the adolescent trial data to the FDA and the European Medicines Agency to expand the vaccine's use in adolescents 12-15 years of age as quickly as possible.

In related news, the companies have commenced dosing in 5 to 11 year-old cohort of their phase 1/2/3 seamless study of the vaccine in children 6 months to 11 years of age. Dosing in the 2 to 5 year-old cohort of the study is expected to be initiated next week.

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