The European Medicines Agency (EMA) has approved the use of the Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15 years.
Pfizer-BioNTech becomes the first vaccine to be authorized for adolescents in the 27 member states of the European Union (EU), reports the Xinhua news agency.
Addressing a press conference here on Friday, Marco Cavaleri, EMA’s vaccine strategy manager, said the drugs regulator had received the data needed to clear the vaccine for young adolescents.
Data shows that it is very effective against COVID-19.
He stressed that the decision must be approved by the European Commission and the various national regulators.
Regulatory agencies in Canada and the United States had previously recommended its use for adolescents.
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% effective in preventing COVID, the EMA said in a statement.
The most common side effects in children 12 to 15 years old are similar to those seen in people 16 years and older, including pain, fatigue, headache, muscle and joint pain, chills and fever.
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