The clinical trial involved giving 1,678 children ages 6 months to under 5 years smaller doses of the vaccine than given to older children and adults. "The study suggests that a low 3-microgram 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," BioNTech Chief Executive Ugur Sahin said in a statement.
They will soon ask global regulators to authorize the shot for the age group and expect to complete their submission of data to the U.S. Food and Drug Administration (FDA) this week.
Meanwhile, Moderna, which released its trial data in March, said, its vaccine was safe and generated a similar immune response in young children as for adults.
New York-based Pfizer Inc and Germany-based BioNTech said that an early analysis of 10 symptomatic COVID-19 cases identified through April 29, while the Omicron variant was dominant, suggested a vaccine efficacy of 80.3% in the under-5 age group. This analysis was not conclusive, as the trial's protocol specified that efficacy should be calculated based on at least 21 cases.
Pfizer and BioNTech said final efficacy data in the age group will be made public when it is available.
The drugmakers had previously tested two doses of the 3 microgram vaccine in the children. But the two-dose trial failed to meet its primary endpoint after results for children ages 2 to 4 showed a weaker immune response than in adults.
The trial participants received their third dose at least two months after their second shot. Pfizer said the vaccine was well tolerated, with most adverse side effects being mild or moderate.
The Pfizer/BioNTech shot is currently authorized for use in all Americans ages 5 and older. Children ages 5 to 11 receive two 10 microgram doses as their primary course, while people aged 12 and older receive two 30 microgram doses.
