Three-dose Covid-19 vaccine produces strong immune response in children ages 6 months to 5 years, Pfizer and BioNTech say

Pfizer/BioNTech to seek Covid vaccine authorization for children under age 5 With three doses, the vaccine was well tolerated, induced a strong immune response, and was 80.3% effective at preventing Covid infections Helen Branswell STAT

The companies said that, with three doses, the vaccine performed about as well in young children as it does in adults. The vaccine was well tolerated, induced a strong immune response and was 80.3% effective at preventing Covid infections at a time when the Omicron variant of the SARS-CoV-2 virus was circulating.

“The study suggests that a low 3-[microgram] dose of our vaccine … provides young children with a high level of protection against the recent Covid-19 strains,” Ugur Sahin, CEO and co-founder of BioNTech, said in a statement.

Children six months to four years of age are the last group for which Covid vaccines have yet to be authorized. The Food and Drug Administration has been under pressure from anxious and frustrated parents to fill this gap.

Moderna has already completed a submission for its Covid vaccine for children aged 6 months to 6 years, based on study of a two-dose vaccine. The two 25 microgram shots, given four weeks apart, generated immune responses similar to what was seen in adults 18 to 25 years old after two doses. But the vaccine efficacy was  43.7% in children aged 6- to 24-months and  37.5% in children aged 2 to under 6 years. When the company announced the results in March it said it was going to study the efficacy of a booster shot in these age group, but results have not been made public to date. ...