If approved, Comirnaty becomes the first Covid-19 vaccine authorised in the EU in the five to 11 years age group, applicable to all 27 EU member states
A US soldier holding the Pfizer–BioNTech vaccine. (Credit: U.S. Secretary of Defense/Wikipedia.)
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the use of Pfizer and BioNTech’s Covid-19 vaccine Comirnaty in children aged five to 11 years.
The Covid-19 vaccine will be administered in two doses of 10µg strength each, in the muscles of the upper arm, three weeks apart.
Pfizer and BioNTech said that the 10µg dose level was selected based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study.
The vaccine was already approved in the EU, for administration in adults, from December last year, and for use in people aged 12 to 17 years, from May this year.
The European Commission (EC) is expected to review the CHMP recommendation to make a final decision on a variation to the conditional marketing authorisation for the vaccine.
If approved, Comirnaty becomes the first Covid-19 vaccine authorised in the European Union (EU) for the five to 11 years age group.
The CHMP positive opinion was based on scientific evidence shared by the companies, including results from a Phase II/III study in around 4,500 children, aged five to 11 years.
In the Phase II/III trial, participants aged five to 11 years received two 10µg doses of vaccine, compared with 30µg doses in participants aged 12 years and above.
Comirnaty showed a favourable safety profile, superior immune responses and 90.7% efficacy after seven days from the second dose, in the current age group.
Pfizer said that no serious safety concerns related to the vaccine were identified by the Data Monitoring Committee, which reviewed the study data.
The CHMP concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, predominantly in children who are at elevated risk of severe Covid-19.
Earlier this month, the US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Comirnaty in the same age group.
The FDA EUA was recommended by the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Furthermore, Pfizer and BioNTech have filed applications with other regulators around the world, seeking regulatory authorisation for their Covid-19 vaccine in children aged five to 11 years.