Pfizer-BioNTech submit data to U.S. FDA for COVID-19 vaccine in younger children

Pfizer Inc. and BioNTech SE submitted preliminary trial information for his or her COVID-19 vaccine in kids aged 5 to 11 to U.S. regulators on Tuesday and stated they’d make a proper request for emergency use authorization within the coming weeks.

Coronavirus infections have soared in kids and hit their highest level in early September, based on information from the American Academy of Pediatrics.

The vaccine, which is already licensed in teenagers aged 12 to fifteen and totally accredited for ages 16 and up within the U.S., has been proven to induce a powerful immune response within the goal age group in a 2,268-participant medical trial, the businesses stated on Sept. 20.

The Pfizer-BioNTech vaccine was licensed in youngsters aged 12-15 roughly a month after the businesses filed for authorization. If the identical timeline is adopted for this software, youngsters may begin receiving their photographs as quickly as late October.

A fast authorization may assist mitigate a possible surge of instances this fall, with faculties already open nationwide.

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Whereas youngsters are much less vulnerable to extreme COVID-19, they will unfold the virus to others, together with weak populations which might be extra vulnerable to extreme sickness.