Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15.
FDA authorized the vaccine for people 16 and older on Dec. 11, 2020.
The agency will likely extend its prior authorization to younger adolescents “if the data submitted support it,” according to Dr. Arnold Monto, acting chair of the Vaccines and Related Biological Products Advisory Committee meetings related to the Pfizer-BioNTech.
Pfizer plans to seek permission from other regulatory agencies to administer the vaccine to children 12 and over in the coming weeks.
The company currently has a Phase 3 trial underway involving 2,260 adolescents 12 to 15. The vaccine was 100% effective in that study, besting the results of a separate trial involving volunteers aged 16 to 25.
All 50 states plan to open up vaccine eligibility to those over 16 starting April 19.
Pfizer and BioNTech also have launched a Phase 1/2/3 trial to evaluate the vaccine in children between six months and 11 years old.
Filed Under: clinical trials, Drug Discovery, Infectious Disease
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