Children will continue to be under observation for two years
The European Union’s drug regulator is evaluating Pfizer and BioNTech’s requirements to expand the scope of their coronavirus vaccine approval to children aged 12 to 15.
The agency said that the European Medicines Agency’s Human Medicines Committee will quickly evaluate the data submitted by Pfizer and BioNTech, and is expected to make a decision in June unless additional information is needed.
The two pharmaceutical companies said in a statement on Friday that their request is based on advanced studies of more than 2,000 adolescents, and the results show that their vaccines are safe and effective. These children will continue to be observed for two years.
Currently, the company’s vaccine has been approved for use in people aged 16 and over. Expanding this approval will allow the young population of Europe to receive the first vaccines against COVID-19 with a lower risk.
Most of the COVID-19 vaccines approved by authorities around the world are for adults who are at an increased risk of contracting the coronavirus. Health authorities believe that vaccinating children of all ages is essential to contain the pandemic. Some studies have shown that older children play an important role in spreading the virus.