The European Medicines Agency (EMA) has started evaluating if the use of Pfizer/BioNTech's coronavirus vaccine can be extended to include young people aged 12 to 15.
An accelerated assessment of data, including results from a large ongoing clinical study involving adolescents from 12 years old, will be carried out by EMA's human medicines committee (CHMP) to decide on the extension, the Agency announced on Monday.
The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Pfizer/BioNTech's vaccine was the first to be authorised for use in the EU in December 2020, and can be administered to people aged 16 and older.
- Belgium could vaccinate 16-17-year-olds during summer holidays
- Pfizer and BioNTech seek EU approval for their vaccine for 12-15 year olds
- Belgium to start vaccinating children from September, taskforce says
On Monday, vaccinologist and member of Belgium's Vaccination Taskforce Pierre Van Damme (UAntwerp), told De Morgen that "in theory, we could already offer the Pfizer vaccine to 16-17-year-olds during the summer holidays."
This scenario is currently being discussed by the Taskforce, which is preparing an opinion on the Covid-19 vaccines for children and adolescents, according to reports.
Last week, Gudrun Briat of the Taskforce already said that, if the EMA authorised it, Belgium could start vaccinating children aged 12 to 15 in September at the earliest, after the adult population will be fully vaccinated.
EMA's decision after the evaluation is expected to be announced in June, unless more information is needed, the Agency announced.