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Pfizer Seeks US Authorization of Covid Vaccine for Ages 5-11
By Staff, Agencies
US drugmaker Pfizer said Thursday it has formally requested emergency use authorization for its Covid-19 vaccine in children age five to 11.
Children have been infected in greater numbers in the latest coronavirus wave driven by the Delta variant, and inoculating young people is seen as key to keeping schools open and helping end the pandemic.
In late September, Pfizer and BioNTech, the German biotechnology giant which co-developed the vaccine, began submitting data to Food and Drug Administration regulators for the highly anticipated authorization.
Pfizer tweeted early Thursday that the two companies had "officially submitted our request" to the FDA "for Emergency Use Authorization [EUA] of our #COVID19 vaccine in children 5 to <12."
"We're committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat," Pfizer said.
The FDA said last week it had scheduled a meeting of an advisory committee to review the data on October 26, before giving its opinion on whether authorization should be granted.
The agency has previously said that once the formal submission was completed, it would complete its review "likely in a matter of weeks rather than months."
The US Centers for Disease Control and Prevention would subsequently publish recommendations for use for healthcare providers administering the shots.
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