The Commission has authorised the Comirnaty XBB.1.5-adapted COVID-19 vaccine, developed by BioNTech-Pfizer. This vaccine marks another important milestone in the fight against the disease. It is the third adaptation of this vaccine to respond to new COVID-19 variants.
The vaccine is authorised for adults, children and infants above 6 months. In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control (ECDC), adults and children from 5 years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history.
The authorisation comes after a stringent evaluation by the European Medicines Agency, under the accelerated assessment mechanism. The Commission authorised this adapted vaccine under an expedited procedure to allow Member States to prepare in time for their autumn-winter vaccination campaigns…
