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- Ελληνικά
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the licensing of an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 sub-variant.
The vaccine - known as Comirnaty Omicron XBB.1.5 - is to be used to prevent COVID-19 disease in adults and children aged 6 months and older.
In line with previous recommendations from the EMA and the European Centre for Disease Prevention and Control (ECDC), adults and children aged 5 years and older who need vaccination should receive one dose, regardless of their vaccination history against COVID-19 disease.
Children aged 6 months to 4 years may receive one or three doses depending on whether they have completed the initial vaccination regimen or have COVID-19 disease.
In its decision to recommend licensure, the CHMP reviewed all available data on Comirnaty and its other adapted vaccines, including data on safety, efficacy and immunogenicity (how well they trigger immune responses). In addition, the Commission evaluated new laboratory data showing a strong response of the adapted vaccine against the XBB.1.5 sub-variant and related strains of the virus that causes COVID-19 disease.
More data on emerging variants are awaited and the Commission will evaluate these data when they become available.
Targeting Omicron XBB.1.5
COVID-19 vaccines are being adapted to better match circulating variants.
This vaccine was developed to target the Omicron XBB variant in accordance with the recommendations of the EMA and ECDC as well as other international regulatory authorities and the World Health Organization.
As the Omicron XBB.1 sub-variant.5 variant is closely related to other currently marketed variants, the vaccine is expected to help maintain optimal protection against COVID-19 disease caused by these other variants as well as by the Omicron XBB.1.5 sub-variant.
Since the initial licensing of the Comirnaty vaccine, the authorities have gained extensive knowledge about the safety of the vaccine. Adverse reactions are usually mild and short-term and include headache, diarrhea, joint and muscle pain, fatigue, chills, fever, and pain or swelling at the injection site. More serious adverse reactions may occur rarely.
The EMEA will now forward the CHMP recommendation to the European Commission for a legally binding decision at European level.
As with other COVID-19 vaccines, the national authorities of EU Member States will determine the use of this vaccine in the context of national vaccination campaigns, taking into account factors such as infection and morbidity rates, the risk for vulnerable groups and the availability of the vaccine.
How the vaccine works
Adapted vaccines act in the same way as the original vaccines.
The vaccine contains molecules called mRNAs that are instructed to produce the spike protein of the Omicron XBB sub-variant.1.5. The spike protein is a protein on the surface of the virus that the virus needs to enter the cells of the body and can differ between virus variants.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike proteins. The person's immune system will then recognise these proteins as foreign and activate natural defences - antibodies and T cells - against them.
If, later, the vaccinated person comes into contact with the virus, the immune system will recognise the spike protein on the surface of the virus and be ready to defend itself. Antibodies and immune cells can protect against COVID-19 disease by killing the virus through synergy, preventing it from entering the body's cells and destroying infected cells.
Comirnaty was first approved in the EU in December 2020, with adapted versions targeting BA.1 strains. and BA.4-5 to receive licensing in September 2022.
(DK)
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