8 July 2022 - y 8, 2022 — Pfizer and BioNTech today announced that the companies have submitted a variation to the EMA requesting to update the conditional marketing authorisation in the European Union with data supporting the vaccination of children ages 6 months to less than 5 years with the 3 mcg dose of Comirnaty (COVID-19 vaccine, mRNA) as a three dose series.
The 3 mcg dose was carefully selected as the preferred dose for children less than 5 years of age based on safety, tolerability, and immunogenicity data.