Europe Evaluating COVID-19 Vaccines for Children

The European Medicines Agency (EMA) confirmed today it has started evaluating an application to extend the use of BioNTech-Pfizer's Comirnaty COVID-19 vaccine to children aged 5 to 11.

Comirnaty was first Authorized in Europe during December 2020 and is currently Authorized for use in people aged 12 and older.

The EMA's human medicines committee will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, to decide whether to recommend extending its use.

In the U.S.A., Comirnaty was also Authorized for use in December 2020 but has since been Approved by the U.S. FDA.

The FDA's vaccine committee has scheduled a session on October 26, 2021, to discuss a request to amend Pfizer-BioNTech's Authorization to administer their COVID-19 mRNA vaccine for children 5 through 11 years of age.

Germany-based BioNTech S.E. and New York-based Pfizer, Inc. co-developed the Comirnaty (BNT162b2) vaccine to prevent severe COVID-19 caused by the SARS-CoV-2 betacoronavirus. It is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen.

The EMA is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines. An independent Management Board governs the EMA. The European Commission makes final decisions.

Separately, Health Canada stated today it will prioritize the review of Pfizer's submission while maintaining high scientific standards for safety, efficacy, and quality.

"Health Canada will only authorize the use of Comirnaty if the independent and thorough scientific review of all the data included in the submission showed that the benefits of the vaccine outweighed the potential risks in this age group," the statement said.