COVID roundup: BioNTech-Pfizer vaccine protects adolescents; plus AZ, GSK-Novavax and Amazon

BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) plan to request Comirnaty (BNT162b2) emergency use authorization amendments from FDA and EMA to include adolescents based on Phase III data showing no COVID-19 cases in subjects ages 12-15 vs. 18 cases for placebo. The study, which randomized 2,260 volunteers 1:1 vaccine to placebo, also observed mean neutralization titers in the adolescents of 1,239.5 one month after booster shots, which exceeded the levels measured in an earlier analysis in volunteers ages 16-25 (705.1).

The partners concurrently announced they have begun dosing volunteers in the first pediatric age group, ages 5-11, in a Phase I/II/III study that will also have cohorts ages 6 months-2 years and 2-5 years...