Pfizer-BioNTech becomes the first vaccine to be authorised for adolescents in the 27 member states of the European Union (EU), reports Xinhua news agency.
Addressing a press conference here on Friday, Marco Cavaleri, EMA’s vaccine strategy manager, said that the medicines’ regulator had received the necessary data to authorise 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 US had already recommended its use for teenagers.
The EMA’s recommendation was based on a study in more than 2,200 adolescents in the US 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 per cent effective at preventing Covid, the 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, tiredness, headache, muscle and joint pain, chills and fever.