BioNTech and Pfizer Friday announced they had submitted data to the European Medicines Agency backing their three-dose COVID-19 vaccine for children aged 6 months to less than 5 years.
The announcement follows the U.S. Food and Drug Administration granting emergency use authorization for the same schedule in its youngest kids on June 17. The three-dose regimen includes a much lower dose than what’s given to adults.
BioNTech and Pfizer say that the data from the trial, which enrolled over 10,000 children, indicates the three doses in young children elicited a strong immune response and has a favorable safety profile. Adverse reactions were generally less frequent in this age group compared to children aged between 5 and 12. As such, the companies want the EU to expand its conditional marketing authorization to include the youngest children.
BioNTech and Pfizer plan to submit the data to other regulatory agencies worldwide. 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.