Pfizer/BioNTech's COVID-19 Vaccine Updated Data Shows Around 76% Efficacy In Toddlers

Pfizer Inc PFE and BioNTech SE BNTX have announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the COVID-19 vaccine in children six months through 4 years of age.

FDA Emergency Use Authorization (EUA) for this age group was given in June. A conditional marketing application is under review by the European Medicines Agency.

Vaccine efficacy was 73.2% among children six months through 4 years of age without evidence of prior COVID-19 infection. 

This analysis was based on 13 cases in the Pfizer-BioNTech COVID-19 Vaccine group (n=794) and 21 cases in the placebo group (n=351). 

The observed cases were primarily caused by omicron BA.2. Omicron BA.4 and BA.5 strains were emerging during the study, with only a few cases accrued. Efficacy results against these strains were inconclusive.

The companies are working with the FDA to prepare a EUA application for an omicron BA.4/BA.5-adapted bivalent vaccine in children six months through 11 years of age.

Among children ages 6 through 23 months, the vaccine was 75.8% effective at preventing COVID-19 and 71.8% for children ages 2 through 4.

Three 3-µg doses of the shot continue to be well-tolerated in this age group. 

Price Action: PFE shares are down 0.29% at $48.76, and BNTX stock is down 0.27% at $147.90 during the premarket session on the last check Tuesday.