Pfizer, BioNTech submit variation to EMA for vaccination of children 6 months to less than 5 years with COMIRNATY
New York: Pfizer Inc. and BioNTech SE have announced that the companies have submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) in the European Union (EU) with data supporting the vaccination of children ages 6 months to less than 5 years with the 3-µg dose of COMIRNATY (COVID-19 vaccine, mRNA) as a three dose series. The 3-µg dose was carefully selected as the preferred dose for children less than 5 years of age based on safety, tolerability, and immunogenicity data.
The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. No new safety signals were identified, and the frequency of adverse reactions observed in children 6 months to less than 5 years were generally lower than in children 5 to less than 12 years.
Pfizer and BioNTech submitted the same data to the U.S. Food and Drug Administration (USFDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3-µg dose series in this age group on June 17. The companies also plan to submit these data to other regulatory agencies around the world.
COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
