The European Medicines Agency (EMA) has approved the use of the Pfizer-BioNTech Covid-19 vaccine for children aged 12 to 15.
Addressing a press conference on Friday (28 May), 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 vaccine was “well tolerated” in children and there were no “major concerns” in terms of side effects, the Amsterdam-based European Medicines Agency said.
With this development, Pfizer-BioNTech has become the first vaccine to be authorised for adolescents in the 27 member states of the European Union (EU), reports Xinhua news agency.
The data shows that it is highly effective against Covid-19. Cavaleri pointed out that the decision needs to be approved by the European Commission and individual national regulators.
Data from clinical trials “is really showing that the vaccine is highly preventative” for young people, he added.
“The vaccine was well tolerated” among children for side effects, and they were “not raising major concerns at this time”, reports France24.
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.
(With inputs from IANS)