Commission authorises adapted COVID-19 vaccine

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.

Background

With our EU Vaccines Strategy, the Commission continues to ensure that Member States have access to the latest authorised COVID-19 vaccines in quantities needed to protect the vulnerable parts of their population and deal with the epidemiological evolution of the virus.

In line with the ECDC-EMA statement on updating COVID-19 vaccines composition for new SARS-CoV-2 virus variants, BioNTech-Pfizer has adapted its COVID-19 vaccine to target the SARS-CoV-2 Omicron strain XBB.1.5. The adapted vaccine is also expected to increase the breadth of immunity against current dominant and emerging variants.

The amendment to the contract with BioNTech-Pfizer signed in May 2023 ensures that Member States continue to have access to vaccines adapted to new COVID-19 variants in the upcoming years.