EC authorises adapted Covid-19 vaccine for member states’ autumn vaccination campaigns

The European Commission (EC) said on September 1 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 EC said.

The vaccine is authorised for adults, children and infants above six 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.

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.

Bulgaria’s Health Ministry said on August 31 that the country will receive 1.3 million doses of the vaccine after it is approved for use by the European Commission.

The first delivery of 80 640 doses is planned for the third week of September.

The vaccines the ministry expects to arrive then are indicated for use in adults and people 12 years of age and older.

Delivery of paediatric vaccines intended for the immunisation of children from six months to 11 years of age is also planned for the last week of September.

Vaccines will continue to be administered free of charge to Bulgarian citizens and permanent residents who request it from their general practitioner, at immunisation offices of the regional health inspectorates and at designated medical facilities.

(Photo: Bulgaria’s Military Medical Academy)

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