The COVID-19 vaccine is already in use. And it is very emotional, especially after reports of several cases of anaphylactic reactions. Who can get vaccinated against the coronavirus? What are the contraindications for COVID-19 vaccination? Can an allergy sufferer, a person suffering from cancer, diabetes or autoimmune diseases be given the vaccine? We check what is included in the summary of product characteristics.
The COVID-19 vaccine available in Poland is a Comirnata medicinal product, intended - as stated in the SmPC, for active immunization of people aged 16 years or older against the COVID-19 disease caused by the SARS-CoV-2 coronavirus.
As with any vaccine, there are times when it should not be given with the coronavirus vaccine. So what are the contraindications for vaccination against COVID-19 and who cannot get vaccinated against the coronavirus? It is worth knowing the information provided in the Summary of Product Characteristics.
COVID-19 vaccine - general recommendations
Before being vaccinated against coronavirus, every person undergoes the so-called a qualification similar to that which takes place before any vaccination, including before the flu vaccination. The doctor who carries out the examination checks, among others, whether the patient is currently he althy - vaccinations are not performed during an active, acute disease with high fever. As stated in the SPC, the presence of a mild infection and / or a mild fever should not delay vaccination.
Other general recommendations contained in the SPC:
Hypersensitivity and anaphylaxis- As cases of anaphylactic events have been reported following administration of the vaccine, it is recommended that adequate treatment and monitoring measures are readily available at the vaccination site for an anaphylactic reaction following administration vaccinations. After the injection, it is recommended to closely observe the patient for at least a quarter of an hour - during this time the patient should not leave the vaccination point. The second dose should not be given to people who experience an anaphylactic reaction after the first dose.
Anxiety-related reactions- Anxiety-related reactions may occur in association with vaccination, includingvasovagal (fainting) reactions, hyperventilation or stress-related reactions - this is a psychogenic reaction to injection with a needle. The manufacturer therefore emphasizes that it is important to take appropriate precautions to avoid injuries as a result of fainting.
Thrombocytopenia and blood clotting disorders.As with other vaccines and intramuscular injections, the vaccine - due to the risk of bleeding or bruising - should be administered with caution to people taking anticoagulant medications or with thrombocytopenia or other blood clotting disorders (e.g. haemophilia).
Immunocompromised people . According to the manufacturer, the efficacy, safety and immunogenicity of the vaccine have not been assessed in immunocompromised people, including patients taking immunosuppressive drugs.
COVID-19 vaccine - contraindications
According to the information included in the summary of product characteristics, a contraindication to the coronavirus vaccine is hypersensitivity to the active substance (i.e. single-stranded, 5 'capped messenger RNA, produced using in vitro cell-free transcription on a DNA template, encoding a peak protein) SARS-CoV-2 virus transmitted in lipid nanoparticles) or to any of the excipients. These substances are:
- ((4-hydroxybutyl) azanediyl) bis (hexane-6,1-diyl) bis (hexyl 2-decanoate) (ALC-0315)
- 2 - [(polyethylene glycol) -2000] -N, N-ditetradecylacetamide (ALC-0159)
- 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
- Cholesterol
- Potassium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Disodium phosphate dihydrate
- Sucrose
- Water for injections
The vaccine is not intended for people under the age of 16 and for pregnant and breastfeeding women . Administration of Comirnaty during pregnancy should only be considered if the potential benefit outweighs any potential risk to the mother and fetus, as there are insufficient studies to confirm its safety.
According to the manufacturer, animal studies have shown no direct or indirect harmful effects on pregnancy, development of the embryo and / or fetus, childbirth or the development of a newborn child. Regarding breastfeeding, it is not yet known whether Comirnaty is excreted in human milk.
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