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.
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.
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* Updated 01/09/2023
I welcome this very timely authorisation of the updated COVID vaccine, which will target emerging and spreading variants. COVID-19 will circulate in parallel to seasonal influenza during the upcoming autumn and winter season, and we need to be ready. This potential double threat will put vulnerable people at increased risk and place further pressure on hospitals and healthcare workers. Vaccination is our most effective tool against both viruses, and therefore I encourage everyone eligible, especially the most vulnerable, to follow the scientific recommendations and get vaccinated as soon as possible.
Stella Kyriakides, Commissioner for Health and Food Safety - 31/08/2023
- Publication date
- 1 September 2023 (Last updated on: 1 September 2023)
- Representation in Cyprus