Three doses of Pfizer’s COVID-19 vaccine produced a strong immune response in children under 5 years of age, the company said on Monday, adding that “it was well tolerated by their clinical trial”. Was”
The clinical trial involved giving 1,678 children aged 6 months to less than 5 years a smaller dose of the vaccine than older children and adults. Ugur Sahin, chief executive of BioNTech, said in a statement: “The study suggests that the low 3-microgram dose of our vaccine, carefully selected based on tolerability data, may reduce the risk of young children with recent COVID-19. Provides a high level of protection against 19 strains.” ,
They will soon ask global regulators to authorize the shot for the age group and expect to submit their data to the US Food and Drug Administration (FDA) this week.
Meanwhile, Moderna, which released its trial data in March, said its vaccine was safe and produced a similar immune response in young children to adults.
New York-based Pfizer Inc and Germany-based BioNTech said a preliminary analysis of 10 symptomatic COVID-19 cases identified as of April 29, while the Omicron variant was dominant, suggested a vaccine efficacy of 80.3% in the under-5 age group. gave. 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 across the age group would be made public when they become available.
The drugmakers had previously tested two doses of the 3 microgram vaccine in children. But the two-dose trial failed to meet its primary endpoint because outcomes for children aged 2 to 4 years showed a weaker immune response than adults.
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 5 years of age and older. Children ages 5 to 11 receive two 10 microgram doses as their primary course, while those 12 and older get two 30 microgram doses.