The Pfizer-BioNTech COVID-19 Vaccine was found to elicit a strong immune response in children 6 months to less than 5 years of age following a third 3µg dose, according to topline data from a phase 2/3 trial.
The pediatric trial (ClinicalTrials.gov Identifier: NCT04816643) included 1678 children who received a third dose of the 3µg formulation at least 2 months after the second dose of a 2-dose series (two 3µg doses administered 21 days apart) at a time when Omicron was the predominant variant.
Data showed the 3 doses met all immunobridging criteria based on geometric mean titer ratio and seroresponse rate, 1 month following the third dose, in both the 6- to 24-month-old population and the 2- to under 5-year-old population, as compared with the second dose in 16- to 25- year-olds.
Vaccine efficacy was reported to be 80.3% in children 6 months to under 5 years of age based on 10 symptomatic COVID-19 cases identified from 7 days after the third dose and accrued as of April 29, 2022. The third dose was well tolerated with no new safety signals identified.
“The study suggests that a low 3ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” said Prof. Ugur Sahin, MD, CEO and co-founder of BioNTech. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”
According to the Companies, a formal analysis of vaccine efficacy will be performed when at least 21 cases have accrued from 7 days after the third dose.
Pfizer-BioNTech COVID-19 vaccine demonstrates strong immune response, high efficacy and favorable safety in children 6 months to under 5 years of age following third dose. News release. Pfizer Inc. and BioNTech SE. Accessed May 23, 2022. https://www.businesswire.com/news/home/20220522005063/en/Pfizer-BioNTech-COVID-19-Vaccine-Demonstrates-Strong-Immune-Response-High-Efficacy-and-Favorable-Safety-in-Children-6-Months-to-Under-5-Years-of-Age-Following-Third-Dose