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 stated they might 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 keeping with information from the American Academy of Pediatrics.
The vaccine, which is already approved in teenagers aged 12 to fifteen and totally authorised 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 stated on Sept. 20.
The Pfizer-BioNTech vaccine was approved in youngsters aged 12-15 roughly a month after the businesses filed for authorization. If the identical timeline is adopted for this utility, youngsters might begin receiving their photographs as quickly as late October.
A speedy authorization might assist mitigate a possible surge of circumstances this fall, with colleges already open nationwide.
Whereas youngsters are much less vulnerable to extreme COVID-19, they will unfold the virus to others, together with susceptible populations which can be extra liable to extreme sickness.
(Reporting by Manas Mishra in Bengaluru; Modifying by Saumyadeb Chakrabarty)
https://globalnews.ca/information/8226335/pfizer-kids-covid-19-vaccine-data-u-s-fda/ | Pfizer sends youngsters’ COVID-19 vaccine trial information to U.S. FDA – Nationwide