European regulators are reviewing use of Pfizer vaccine for adolescents

European regulators reviewing Pfizer vaccine for adolescents European drug regulators are reviewing a request by Pfizer and BioNTech to extend the use of their coronavirus vaccine to children as young as 12 years old. Nathaniel Weixel TheHill

European drug regulators are reviewing a request by Pfizer and BioNTech to extend the use of their coronavirus vaccine to children as young as 12 years old.

In a statement, the European Medicines Agency (EMA) said its human medicines committee will carry out an accelerated assessment of data submitted by the companies, including results from a large ongoing clinical study involving more than 2,000 adolescents. 

The agency is expected to reach a decision in June unless supplementary information is needed. If the EMA approves the change in authorization, the decision will then be sent to the European Commission, which will issue a final legally binding decision applicable in all 27 member states of the European Union.

The companies submitted a similar request to the U.S. Food and Drug Administration (FDA) almost a month ago, but the agency has yet to make a decision. Pfizer and BioNTech said they plan to request additional amendments with other regulatory authorities worldwide.

The companies’ vaccine is currently approved for use in people ages 16 years and older. The other two COVID-19 vaccines used in the U.S. – made by Moderna and Johnson & Johnson – are authorized for emergency use in people ages 18 and older. ...