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Pfizer and BioNTech are formally asking the Biden administration to authorize the usage of their COVID-19 vaccine for kids ages 5 to 11.
Pfizer tweeted on Thursday that the businesses had submitted their formal request for Emergency Use Authorization of the vaccine to the Meals and Drug Administration.
“With new instances in youngsters within the U.S. persevering with to be at a excessive stage, this submission is a vital step in our ongoing effort towards #COVID19,” the pharmaceutical big stated.
The submission is the most recent improvement within the push to develop use of the vaccine to youthful youngsters, a course of being carefully watched by many anxious dad and mom as the brand new college 12 months will get underway.
The Pfizer-BioNTech vaccine has full FDA approval for folks ages 16 and older, and people between the ages of 12 and 15 can get the shot below the present emergency use authorization.
The appliance was broadly anticipated after Pfizer and BioNTech submitted knowledge to the federal government final month displaying that their vaccine produced a “sturdy” antibody response in children from 5-11 and had “favorable” security outcomes.
The FDA has scheduled a gathering with an unbiased advisory committee for Oct. 26 to debate Pfizer’s request to authorize its vaccine for kids aged 5-11.
The FDA may then resolve shortly to grant the authorization, although that may very well be held up if the committee has points with the applying.