Pfizer says 3-dose COVID vaccine for under 5s produces strong immune response

Pfizer and BioNTech will request authorization from the US Food and Drug Administration this week for their three-dose COVID-19 vaccine for children ages 6 months to under 5 years, the companies announced this morning.Top-line clinical trial results indicate that the vaccine series is safe and produces a strong immune response against the pandemic virus, according to the companies."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," BioNTech CEO Ugur Sahin said in a statement.The trial involved 1,678 children who were given two doses of the vaccine 21 days apart and then a third dose at least two months after the second dose.A month after the third dose, researchers looked at SARS-CoV-2 antibody levels in the children and found that both the 6- to 24-month-old infants and the 2- to under 5-year-old children produced similar antibody levels as seen in teens and young adults, 16- to 25-year-olds.The companies also noted that a descriptive analysis based on 10 symptomatic COVID-19 cases identified in the trial suggests that the three doses are 80 percent effective against an omicron infection. The company added that it was also requesting FDA authorization, raising parents' hopes that a much-desired vaccine could be available as early as sometime in May.But those hopes were soon dashed by reports that the FDA was considering delaying the review of Moderna's vaccine until it had data from Pfizer and BioNTech's third dose.