JUST IN: Pfizer seeks FDA emergency use authorization of its Covid-19 vaccine for children ages 5 to 11
If authorized, this would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.Pfizer submits data on Covid-19 vaccine for kids ages 5 to 11 to FDA, not seeking EUA yetLast month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and generated a"robust" antibody response in children ages 5 to 11.
In anticipation of the request, the FDA last week scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the vaccine in children ages 5 to 11 on October 26. If the FDA OKs it, a panel of CDC vaccine advisers will meet to consider whether to recommend its use.
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