Pfizer Inc. PFE, -2.19% and German partner BioNTech SE BNTX, +0.02% on Tuesday announced updated COVID vaccine data supporting efficacy in children aged 6 months through 4 years of age. The companies said updated analysis from 34 cases occurring at least seven days after a three-dose regimen showed 73.2% vaccine efficacy among children in that age group. The vaccine efficacy remained consistently above 70% in both children aged six months through 23 months and the 2 through 4 years age groups. Sequencing of the cases confirmed that most were caused by omicron BA.2, suggesting broader protection across variants. The U.S. Food and Drug Administration authorized the vaccine for very young children on June 17 and it’s currently under review by the European regulator. “While these results confirm that three 3-ug doses of our COVID-19 vaccine provide young children with a high level of protection at a time when the Omicron BA.2 strain was highly prevalent with a favorable safety profile, we are also developing an Omicron BA.4/BA.5-adapted bivalent vaccine in this age group to address these sublineages,” said Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech. Pfizer shares were up 0.1% premarket, while BioNTech shares were slightly lower.
