Positive CHMP opinion for Comirnaty vaccine in children 6 months to less than 5 years in the European Union
Pfizer Inc. and BioNTech SE announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization (MA) for a 3-µg dose of Comirnaty (COVID-19 vaccine, mRNA), which is based on the wild-type spike protein of SARS-CoV-2, as a three-dose series for children ages 6 months to less than 5 years (also referred to as 6 months through 4 years of age)
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
Today’s recommendation is based on data from a Phase II/III randomized, controlled trial that included 4,526 children aged 6 months to less than 5 years. In the trial, children received a third 3-µg dose of the original Pfizer-BioNTech COVID-19 Vaccine at least two months after the second dose at a time when Omicron BA.2 was the predominant variant. Following the third dose in this age group, the companies’ original COVID-19 vaccine was found to be 73.2% (2-sided 95% CI: 43.8%, 87.6%) effective at preventing COVID-19, with a favorable safety profile similar to placebo. The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity.
The FDA granted emergency use authorization (EUA) of the original Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series in this age group in June 2022. Submissions to other regulatory agencies around the world are ongoing.
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