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The appliance to the U.S. Meals and Drug Administration comes as COVID-19 infections have soared in youngsters, hitting their highest level within the pandemic in early September, in response to information from the American Academy of Pediatrics.
The FDA has set a date of Oct. 26 for outdoor advisers to fulfill and talk about the Pfizer software, making it attainable for youths to start receiving the vaccines shortly afterwards.
A fast authorization may assist mitigate a possible surge of instances this fall, with colleges already open nationwide.
The vaccine, which is already licensed in 12 to fifteen yr olds and totally authorized for ages 16 and up, has been proven to induce a powerful immune response within the goal age group in a 2,268 participant medical trial, the businesses mentioned on Sept. 20.
The Pfizer-BioNTech vaccine was licensed in children aged 12-15 roughly a month after the businesses filed for authorization.
Whereas children are much less vulnerable to extreme COVID-19, they will unfold the virus to others, together with weak populations which are extra prone to extreme sickness.
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