EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children

Pfizer and BioNTech announced in a Nov. 25, 2021 press release that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine, Comirnaty, in children five to under 12 years of age. The European Commission (EC) will review the CHMP recommendation. If the EC grants a variation to the Conditional Marketing Authorization (CMA), the decision will be immediately applicable to all 27 European Union member states. If authorized, Comirnaty will be the first COVID-19 vaccine authorized in the EU for individuals five to under 12 years of age. The current CMA was granted for people 12 years of age and older, and it was expanded to include a booster dose at least six months after the second dose in people 18 years of age and older.

The positive opinion adopted by the CHMP is based on scientific evidence, including results from a Phase II/III randomized, controlled trial that showed a favorable safety profile, robust immune responses, and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from seven days after the second dose, during a period when Delta was the prevalant strain, the companies said in the press release. The companies have also submitted requests for authorization of their COVID-19 vaccine in the five to 12 age group to other regulators around the world, and data from ongoing clinical studies in younger ages is upcoming. 

Pfizer and BioNTech do not expect the introduction of pediatric doses to impact the existing supply agreements in place with governments and international health organizations around the world.