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After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking E.U. authorization to distribute the vaccine to that age group.
BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries starting in June.
The companies requested in early April that FDA lower the vaccine eligibility from 16 to 12 years of age.
Janet Woodcock, FDA’s acting commissioner, vowed to review the request “as expeditiously as possible using our thorough and science-based approach” but declined to estimate how long it would take to do so.
BioNTech and its partner Pfizer are currently overseeing vaccine clinical trials for children as young as six months old.
The companies also plan on asking other international regulatory bodies to authorize their vaccine for younger adolescents.