Research & Development
Pfizer Inc and BioNTech provides first results of pivotal trial of COVID-19 vaccine in children aged five to 11 years
21 September 2021 -

Healthcare company Pfizer Inc (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) on Monday reported safety profile and robust neutralizing antibody responses in children five to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart under its Phase 2/3 trial of COVID-19 vaccine.

The partnership added that the antibody responses in the participants given 10 µg doses were comparable to those recorded in a prior study in people 16 to 25 years of age immunized with 30 µg doses.

Additionally, the data summarized from this Phase 2/3 study, which is enrolling children six months to 11 years of age, was for 2,268 participants who were five to 11 years of age and received a 10 µg dose level in a two-dose regimen.

In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6, demonstrating strong immune response in this cohort of children one month after the second dose. This compares well to the GMT of 1146.5 from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg.

According to the company, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age. The companies plan to share the data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as well as submit data from the full Phase 3 trial for scientific peer-reviewed publication.



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