Drugmakers Pfizer Inc and BioNTech SE said on Monday that three doses of their COVID-19 vaccine generated a strong immune response in children under the age of five in their clinical trial.
The companies said the vaccine was safe and well-tolerated by the children, and they plan to soon ask global regulators to authorize the shot for the age group, children for whom no vaccine is currently approved in most of the world.
They expect to complete their submission of data to the U.S. Food and Drug Administration (FDA) this week, they said.
Pfizer and BioNTech said that three shots of a 3 microgram formulation of their vaccine generated a similar immune response in children aged six months to under five years of age as in 16 to 25-year-olds who had received two doses of the 30 microgram formulation of the vaccine in an earlier clinical trial.
"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.
The drugmakers said that an early analysis of 10 symptomatic COVID cases identified through April 29, while the Omicron variant was dominant, suggested vaccine efficacy of 80.3% in the under-five age group. This analysis is 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 shared 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 two to four-year olds showed a weaker immune response than in adults.
The 1,678 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.
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