Pfizer, BioNTech COVID booster elicits immune response in young children

May 24, 2022

Pfizer and BioNTech have shared promising data from their vaccine booster trial in young children, revealing that they plan to complete their FDA submission this year.

Previously, a two-dose regimen proved ineffective for children, so the results come as a win for the companies who have been working toward clearing all age groups for the vaccine.

In the phase 2/3 trial, approximately 1,678 kids aged 6 months to under 5 years received a booster at the time when omicron was the leading variant. Overall, vaccine efficiency of 80.3% was observed.

“The study suggests that a low 3-ug 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,” said Ugur  Sahin, CEO and co-founder of BioNTech. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”