The trial shows that it is safe, well tolerated, and generates "strong" neutralizing antibody responses in children
Pfizer and BioNTech have announced the results of a Phase 2/3 trial showing that their COVID-19 vaccine has a favorable safety profile and strong neutralizing antibody responses in children aged 5 to 11. However, the trial was conducted with a lower dose than that used in individuals over 12 years of age.
Antibody responses in participants who received the 10 µg (microgram) dose were comparable to those observed in a previous Pfizer-BioNTech study in individuals aged 16 to 25 years immunized with the 30 µg dose. The 10 µg dose was carefully selected as the preferred dose based on safety, tolerability, and immunogenicity in children aged 5 to 11 years.
“Over the past nine months, hundreds of millions of people aged 12 and older around the world have received our COVID-19 vaccine. We are eager to extend the protection the vaccine provides 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,” said Albert Bourla, Pfizer Chairman and CEO.
“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, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated with a lower dose are consistent with what we have observed with our vaccine in other older populations with a higher dose.”
The trial with children
Children aged 5 to 11 received two injections of a 10-microgram dose of the vaccine , one-third the size of the dose given to people aged 12 and older. The companies expect to have data on the vaccine's effectiveness in children aged 2 to 5 and in children aged 6 months to 2 years as early as the fourth quarter of this year, Reuters reports.
Unlike the larger clinical trial that drug manufacturers previously conducted in adults, the pediatric trial with 2,268 participants was not primarily designed to measure vaccine efficacy by comparing the number of Covid-19 cases in vaccine recipients with those who received a placebo .
In contrast, the trial compares the amount of neutralizing antibodies induced by the vaccine in children with the response of older recipients in the adult trial.