Updated efficacy data from a Phase 2/3 trial testing three 3-g doses of the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months to 4 years have been released by the vaccine developers. The new data supports earlier disclosed interim efficacy findings obtained in March and April 2022, says the Pfizer/BioNTech press release.
On June 17, the U.S. Food and Drug Administration (FDA) granted this vaccine emergency use authorization (EUA) for this age range. In addition, the European Medicines Agency (EMA) is currently reviewing an application for conditional marketing authorization in this age group.
Bio.News previously reported that FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include a single booster shot for children aged 5–11. The shot can be received no earlier than 5 months after receiving the primary series of the vaccine, according to the agency’s press release.
This is the latest in a week of news from Pfizer and BioNTech, which announced on Monday that they have requested EUA for their new Omicron-adapted booster vaccine, Bio.News reported.
Results show efficacy in youngest children
The Pfizer-BioNTech COVID-19 vaccine (3-μg) was administered to research participants in a three-dose series, or a placebo (2:1 randomization), according to the press release.
The secondary endpoint of the trial – vaccine effectiveness – was 73.2% (2-sided 95% CI: 43.8%, 87.6%) in children aged 6 months to 4 years who had no signs of past COVID-19 infection.
This analysis was based on 21 cases in the placebo group and 13 cases in the Pfizer-BioNTech COVID-19 vaccine group, all of which were dosed between March and June 2022.
“Building on the strong safety and immunogenicity data that led to FDA authorization of our COVID-19 vaccine for children 6 months through 4 years, we are pleased to share confirmatory evidence that a full course of vaccination helps protect against symptomatic disease, particularly during a time when the Omicron BA.2 strain was predominant,” said Albert Bourla, Chairman and CEO of Pfizer.
“While these results confirm that three 3-µg doses of our COVID-19 vaccine provide young children with a high level of protection at a time when the Omicron BA.2 strain was highly prevalent with a favorable safety profile, we are also developing an Omicron BA.4/BA.5-adapted bivalent vaccine in this age group to address these sublineages,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.
Pfizer and BioNTech requested an upgrade to the Conditional Marketing Authorization (CMA) in the European Union (EU) to include children ages 6 months through 4 years on July 8 by submitting safety and immunogenicity data to the European Medicines Agency (EMA).
In the upcoming weeks, the businesses intend to submit the updated efficacy data to the FDA, EMA, and other international regulatory bodies.