Three doses of Pfizer's COVID-19 vaccine generate strong immune response in children under age 5, the company said on Monday adding, “it was well-tolerated by them clinical trial" 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.