BioNTech and Pfizer announced on Friday that they had submitted data to the European Medicines Agency supporting their three-dose COVID-19 vaccine for children aged 6 months to under 5 years.
The announcement follows the U.S. Food and Drug Administration granting emergency use authorization for the same schedule in its youngest children on June 17. The three-dose regimen includes a much lower dose than that given to adults.
BioNTech and Pfizer say data from the trial, which recruited more than 10,000 children, indicates that all three doses in young children elicited a strong immune response and had a favorable safety profile. Side effects were generally less common in this age group compared to children aged 5 to 12 years. Thus, the companies want the EU to extend its conditional marketing authorization to the youngest children.
BioNTech and Pfizer plan to submit the data to other regulatory bodies around the world. The request from Pfizer and BioNTech comes several months after Moderna asked the EMA to grant conditional marketing authorization for its coronavirus vaccine in children under 6 years old.