Pfizer, BioNTech tout COVID booster data for young children and plan to finish FDA filing

Pfizer and BioNTech, after revealing positive data from a COVID-19 vaccine booster trial in young children, plan to complete their rolling FDA submission this week. The companies said that the safety, immunogenicity and vaccine efficacy data for the three-dose regimen were consistent with the data seen in adults. Efficacy reached 80.3% in the booster trial. Previously, a two-dose regimen failed to work in young children. The age group is the only one not yet cleared for a COVID-19 vaccine. The shots are one-tenth of the dose strength for adults. In the trial, 1,678 children received a third dose at a time when omicron was the dominant COVID-19 variant.