Variation submitted to EMA for the vaccination of children 6 months to less than 5 years with Comirnaty- Pfizer + BioNTech SE
— Pfizer Inc. and BioNTech SE 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 II/III 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 FDA 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. .
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