Europe Authorizes COVID-19 Vaccine Comirnaty for Adolescents

The European Medicines Agency (EMA) announced on May 28, 2021, the Human Medicines Committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty (BioNTech-Pfizer) to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above.

The CHMP noted that the trial could not have detected rare side effects due to the limited number of children included in the study.

The committee also noted that EMA’s safety committee is currently assessing very rare cases of myocarditis and pericarditis after vaccination with Comirnaty, mainly in people under 30 years of age. Currently, there is no indication that these cases are due to the vaccine, and EMA is closely monitoring this issue.

Despite this uncertainty, the CHMP considered that the benefits of Comirnaty in children aged 12 to 15 outweigh the risks, particularly in children with conditions that increase the risk of severe COVID-19.

The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns across the Member States, through the EU pharmacovigilance system, and ongoing and additional studies by the company and by European authorities.

The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public and animal health in the European Union.