The European Commission (EC) has approved the adapted Covid-19 vaccine Comirnaty manufactured by Pfizer/BioNTech and intended specifically for XBB.1.5 Omicron variant of Covid-19, as confirmed by Latvia’s State Agency of Medicines (ZVA).
This decision was made by EC based on recommendations issued by European Medicines Agency (EMA).
The vaccine, known as Comirnaty Omicron XBB.1.5, can be used to prevent Covid-19 infection in adults and children starting of six months of age.
According to previous recommendations from EMA and European Centre for Disease Prevention and Control (ECDC) for adults and children five years and older, one dose of this vaccine regardless of previous Covid-19 vaccination is enough.
Children of six month to four years of age can receive one or three doses depending on whether or not the child has completed the primary vaccination course or has recovered from Covid-19 infection.
When making the decision to recommend the registration of this vaccine, EMA took into account all available data regarding Comirnaty vaccine and other adapted vaccines, as well as data on safety, efficacy and immunogenicity (how well the vaccine initiates the immune response).
EMA also assessed the latest laboratory data, which indicates this adapted vaccine’s strong effect on the XBB.1.5 variant and other variant’s of the virus that cause Covid-19, ZVA reports.
Latvia’s National Health Service (NVD) reports that supplies of adapted Comirnaty Omicron XBB.1.5 to the country will be organised this week. Information about the vaccine’s availability will become available in the coming days.
Because Omicron XBB.1.5 variant is very similar to other variants of the virus, it is expected this vaccine will help ensure optimal protection against Covid-19 infection, ZVA notes.
Side-effects from the vaccine include headache, diarrhoea, joint and muscle pain, fatigue, chills, fever and pain or swelling of the injection spot. In rare cases there can be more serious side-effects. With the decision from the European Commission, its use is permitted in the European Union.
EMA note that similarly to other Covid-19 vaccines, EU member states’ own national institutions will dictate how this vaccine is to be used in national vaccine campaigns.
Adapted vaccines function like original vaccines. This vaccine contains mRNA molecules that contain information for the formation of Omicron XBB.1.5 spike protein.
The spike protein is a protein on the surface of the virus that the virus needs to enter the body’s cells and can be different for different types of virus. After receiving the vaccine, some cells in the body read the instructions contained in the mRNA and temporarily form spike proteins.
The immune system of the vaccinated person identifies this protein as foreign and activates natural protection – generates antibodies and T cells. If a vaccinated person later comes into contact with the virus, his or her immune system will recognise its spike protein and will be prepared to battle it.
Comirnaty vaccine was registered in the EU for the first time in December 2020. Adapted versions of the vaccine created to battle BA.1 and BA.4-5 variants were registered in September 2022.
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