September 20, 2021 -- Pfizer and BioNTech's COVID-19 vaccine is safe and well tolerated and showed robust neutralizing antibody responses in children between the ages of 5 and 11, according to clinical trial results.
These are the first results for any COVID-19 vaccine in children under the age of 12. The companies plan to submit the data to the U.S. Food and Drug Administration for an emergency use authorization.
Approximately 2,270 children were administered a two-dose regimen of 10 µg. By comparison, people 12 and older received two doses of 30 µg three weeks apart. The subjects' SARS-CoV-2-neutralizing antibody geometric mean titer was 1,197.6 (95% confidence interval, 1106.1-1296.6), demonstrating a strong immune response in children one month after the second dose.
Results of the vaccine's efficacy in children younger than 5 should be available soon.