The European Medicines Agency (EMA) has given the green light for the use of Pfizer/BioNTech's coronavirus vaccine for children aged 12 to 15, making it the first one to be administered to this age group.
On Friday afternoon, EMA’s human medicines committee (CHMP) recommended granting an extension of indication for the Pfizer vaccine, to include use in children aged 12 to 15.
Previously, the vaccine was already approved for use in adults and adolescents aged 16 and above.
The effects of the vaccine in children were investigated in a study with 2,260 children aged 12 to 15 years, carried out under its paediatric investigation plan (PIP), which was agreed by EMA's Paediatric Committee (PDCO).
The trial showed that the immune response to the Pfizer/BioNTech vaccine in this group was comparable to the immune response in the 16 to 25 age group.
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The study showed that the vaccine was 100% effective at preventing Covid-19 in the age group, although EMA stated that the true rate could be between 75% and 100%.
The most common side effects in children aged 12 to 15 are similar to those in people aged 16 and above, and include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever.
These effects, however, are usually mild or moderate and improve within a few days from the vaccination.
The CHMP concluded that the benefits of the vaccine in this age group outweigh the risks.
"The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns across the Member States, through the EU pharmacovigilance system and ongoing and additional studies by the company and by European authorities," the EMA stated.