EMA approves Pfizer-BioNTech vaccine for 12 to 15-year olds

The European Medicines Agency (EMA) on Friday approved the use of the Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15, reported Xinhua.

Pfizer-BioNTech becomes the first vaccine to be authorized for adolescents in the 27 member states of the European Union (EU).

Marco Cavaleri, EMA's vaccine strategy manager, told a press conference that the medicines' regulator had received the necessary data to authorize the vaccine for younger teens. The data shows that it is highly effective against COVID-19.

He pointed out that the decision needs to be approved by the European Commission and individual national regulators.

Regulators in Canada and the United States had already recommended its use for teenagers.

EMA's recommendation was based on a study in more than 2,200 adolescents in the United States showing that the vaccine was safe and effective. The trial showed that the immune response in this group was comparable to that in the 16-25 age group.

The study shows that the vaccine was 100 percent effective at preventing COVID-19, EMA said in a statement.

The most common side effects in children aged 12 to 15 are similar to those in people aged 16 and above. They include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever.