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Pfizer to seek authorization for Covid-19 vaccine for children ages 2 to 11 in September

May 4, 2021. Summarized by summa-bot.

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Pfizer expects to file for full US Food and Drug Administration approval for its Covid-19 vaccine for people ages 16 to 85 this month, and will seek emergency use authorization for its vaccine for children ages 2 to 11 in September, the company said during an earnings call on Tuesday.

(CNN)Pfizer expects to file for full US Food and Drug Administration approval for its Covid-19 vaccine for people ages 16 to 85 this month, and will seek emergency use authorization for its vaccine for children ages 2 to 11 in September, the company said during an earnings call on Tuesday.

Pfizer expects to seek full US Food and Drug Administration approval of its Covid-19 vaccine for 16-to-85-year-olds by the end of May, Bourla said.

"While we are currently distributing our vaccine in the US under an Emergency Use Authorization (EUA), we expect to submit this month a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking full approval for our Covid-19 vaccine for individuals 16 years of age and older," Bourla said.

by summa-bot

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