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Image header Agence Europe
Europe Daily Bulletin No. 13241
Contents Publication in full By article 13 / 19
EU RESPONSE TO COVID-19 / Health

EU authorises BioNTech-Pfizer vaccine suitable for autumn vaccination campaigns

On Friday 1 September, the European Commission authorised the Covid-19 vaccine adapted to Comirnaty XBB.1.5, developed by BioNTech-Pfizer.

This vaccine, which targets the Omicron XBB.1.5 sub-variant, marks an important new step in the fight against the disease. This is the third adaptation of this vaccine to respond to new Covid-19 variants.

The vaccine has been approved for adults, children and infants aged over six months. In line with previous recommendations from the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), adults and children aged five and over who need to be vaccinated should receive a single dose, regardless of their history of coronavirus vaccination. 

This authorisation follows a rigorous assessment by the EMA under its accelerated assessment mechanism. The Commission has authorised this adapted vaccine using a fast-track procedure to enable Member States to prepare their autumn and winter vaccination campaigns in good time.

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

The amendment to the contract with BioNTech-Pfizer signed in May 2023 ensures that Member States will continue to have access to vaccines adapted to the new Covid-19 variants over the coming years. (Original version in French by Lionel Changeur)

Contents

ECONOMY - FINANCE - BUSINESS
SECTORAL POLICIES
COMMISSIONERS-DESIGNATE HEARINGS IN EUROPEAN PARLIAMENT
INSTITUTIONAL
EXTERNAL ACTION
EU RESPONSE TO COVID-19
NEWS BRIEFS