Pfizer to seek authorization for Covid-19 vaccine for children ages 2 to 11 in September
3 years, 7 months ago

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

CNN  

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 to seek approval for vaccine this month 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, we expect to submit this month a Biologics License Application to the US Food and Drug Administration seeking full approval for our Covid-19 vaccine for individuals 16 years of age and older,” Bourla said. A move to ease vaccine distribution Pfizer also said Tuesday it has submitted information to the FDA that may allow its Covid-19 vaccine to be stored at standard refrigerator temperatures.

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