Pfizer submits information for COVID-19 vaccine in youthful kids By Reuters

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

Coronavirus infections have soared in kids, hitting their highest level in early September, in response to information from the American Academy of Pediatrics.

The vaccine, which is already licensed in teenagers aged 12 to fifteen and absolutely accepted for ages 16 and up, induced a robust 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 children aged 12-15 roughly a month after the businesses filed for authorization. If the identical timeline is adopted for this utility, youthful kids may begin receiving their pictures as quickly as late October.

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

Whereas children are much less prone to extreme COVID-19, they’ll unfold the virus to others, together with weak populations which can be extra vulnerable to extreme sickness.

The businesses stated they plan to submit the info to the European Medicines Company and different regulatory authorities.

Information from the businesses’ trial confirmed the two-shot vaccine generated an immune response in kids that matched what was beforehand noticed in 16-to-25 yr olds. The protection profile was additionally similar to the older age group, Pfizer (NYSE:) stated.

The drugmakers are additionally testing the vaccine in kids aged 2-to-5 and people aged 6 months-to-2 years, with information anticipated within the fourth quarter.

Moderna (NASDAQ:)’s COVID-19 vaccine isn’t but licensed to be used in adolescents in the US, whereas it has gained authorization for that age group in Europe.