The European Medicines Agency (EMA), the body that approves medication for use in the EU, has announced it is to review clinical trials on the effects of the Pfizer/BioNtech coronavirus vaccine on children aged 5 to 11.
The vaccine is currently only licensed in the EU for those aged 12 and over. Manufacturers Pfizer/BioNtech have passed on the data they collected during their own trials on younger age groups.
The study data apparently demonstrate that the vaccine is well tolerated by children in this age group, who receive only one-third of the adult dose, and produces a stable immune response.
According to the Amsterdam-based EMA, its experts are now reviewing the study data. A recommendation on the extension of the vaccine's approval is expected within the next few months.
The final approval will need to be given by the European Commission, however, though after EMA approval, commission approval is generally considered a formality.
US regulators are reviewing a similar request by Pfizer/BioNtech, with a decision expected within weeks.
