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Pfizer, BioNTech COVID-19 Vaccine Effective in Pediatric Patients
The COVID-19 vaccine elicited a neutralizing antibody geometric mean titer of 1,197 in pediatric patients, demonstrating strong immune response one month after the second dose.
Pfizer and BioNTech recently announced that two doses of their COVID-19 vaccine elicited neutralizing antibody responses in pediatric patients in a Phase 2/3 clinical trial.
In the trial, 2,268 participants aged 5 to 11 received a 10-microgram dose of the vaccine in a two-dose regimen. The SARS-CoV-2-neutralizing antibody geometric mean titer was 1,197, demonstrating strong immune response one month after the second dose.
The 10-microgram dose is the preferred dose for safety, tolerability, and immunogenicity in children 5 to 11 years of age, a Pfizer spokesperson explained. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Albert Bourla, chairman and chief executive officer at Pfizer, said in the announcement.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Bourla continued.
The Phase 2/3 study is currently enrolling 6 months to 11 years of age. Pfizer and BioNTech will share additional data from the trial with the FDA, European Medicines Agency (EMA), and other regulators as soon as possible.
The companies stated that they expect to include the data in a submission for emergency use authorization (EUA) as they accrue safety and efficacy data required for full FDA approval.
Topline results from the other two cohorts in the trial, including children 2 to 5 years of age and children 6 months to 2 years of age, are expected as soon as the fourth quarter of this year.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.
Findings from the Phase 2/3 study are comparable to Phase 3 trial findings, which showed that the COVID-19 vaccine elicited 100 percent efficacy and robust antibody responses in adolescents 12 to 15 years of age in the US.
