Pfizer sends kids’ COVID-19 vaccine trial data to U.S. FDA – National
Pfizer Inc. and BioNTech SE submitted preliminary trial information for his or her COVID-19 vaccine in youngsters aged 5 to 11 to U.S. regulators on Tuesday and mentioned they’d make a proper request for emergency use authorization within the coming weeks.
Coronavirus infections have soared in youngsters and hit their highest level in early September, in accordance with information from the American Academy of Pediatrics.
The vaccine, which is already approved in teenagers aged 12 to fifteen and totally permitted for ages 16 and up, has been proven to induce a powerful immune response within the goal age group in a 2,268-participant scientific trial, the businesses mentioned on Sept. 20.

The Pfizer-BioNTech vaccine was approved in children aged 12-15 roughly a month after the businesses filed for authorization. If the identical timeline is adopted for this software, children may begin receiving their pictures as quickly as late October.
A speedy authorization may assist mitigate a possible surge of instances this fall, with colleges already open nationwide.
Whereas children are much less prone to extreme COVID-19, they’ll unfold the virus to others, together with susceptible populations which are extra susceptible to extreme sickness.
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(Reporting by Manas Mishra in Bengaluru; Modifying by Saumyadeb Chakrabarty)
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