
Chief state sanitary doctor of Kazakhstan signed a decree "On amendments to the resolution of the Chief state sanitary doctor of the Republic of Kazakhstan dated 11 June 2021 № 28".
According to the resolution of a vaccine against COVID-19 (Vero Cell), inactivated (Sinopharm) – made from a strain of SARS-CoV-2, 19nCoV-CDC-Tan-HB02, which instill in Vero cells for the cultivation, harvesting, inactivation of β-propiolactone, concentration and purification, followed by adsorption of the adjuvant aluminium hydroxide with the formation of a liquid vaccine. The vaccine does not contain antibiotics and preservatives.
The vaccine is intended for adults over 18 years of age, available in the form of:
- a single-dose bottle contains 0.5 ml of the product for administration;
- the bottle contains 1.0 ml of the product for two injections, 0.5 ml is required for each injection as a single dose; it is forbidden to administer 1.0 ml to one person.
Vaccination schedule: two doses with an interval between injections of 21-28 days, each dose is 0.5 ml.
The recommended route of administration is intramuscular, preferably into the deltoid muscle of the shoulder. Intravascular administration is strictly prohibited.
The remainder of the 1.0 ml vaccine, after the first opening of the vial, is stored at room temperature for no more than 1 hour or at a temperature of plus 2 to plus 8 ° C - no more than 6 hours.
Before the second intake of the vaccine, the surface of the rubber stopper must be disinfected. In order to avoid cross-contamination, the dose intake from the vial into the syringe must be performed immediately before administration. Use the vaccine typed into the syringe should be used immediately, since it does not contain preservatives. The inoculation dose error caused by repeated aspiration into the syringe should be minimized. If the remaining vaccine in the vial is less than 0.5 ml, it should be discarded, and do not mix the remnants of the vaccine from different vials.
The need for repeated immunization with this drug has not been determined.
Contraindications to the introduction of the vaccine:
- allergy to any component (including excipients) of the vaccine;
- allergic reactions to vaccines (acute allergic reaction, angioedema, shortness of breath);
- uncontrolled epilepsy or other progressive diseases of the nervous system, as well as a history of Guillain-Barre syndrome;
- pregnancy and lactation;
- age up to 18 years.
It is forbidden to use this vaccine again if adverse reactions from the nervous system have occurred after vaccination.
The vaccine should be used with caution in patients with:
- acute illnesses, exacerbation of chronic diseases and fever; if necessary, vaccination is postponed by a doctor;
- diabetics, and persons with a history or family history of seizures, epilepsy, encephalopathy, mental illness;
- with blood clotting disorders and thrombocytopenia, due to the risk of bleeding that may occur during intramuscular administration of the vaccine;
- with impaired immune function as a malignant tumor, nephrotic syndrome, AIDS patients (data on the safety and effectiveness of the vaccine in these people have not been obtained).
People receiving immunoglobulins should be vaccinated with this vaccine at intervals of at least 1 month to exclude the impact on immune efficacy.
Combined use with other drugs: combined use with immunosuppressive drugs, such as immunosuppressive drugs, chemotherapy drugs, anti-metabolic drugs, alkylating agents, cytotoxic drugs, corticosteroids, etc. can reduce the body's immune response to this product.
Frequency of side effects:
- very often: pain at the injection site; headache;
- often: fever, fatigue, myalgia, arthralgia, cough, shortness of breath, diarrhea, itching;
- infrequently: redness, swelling, thickening, rash, itching dizziness, anorexia, vomiting, oropharyngeal pain, dysphagia, runny nose, constipation, hypersensitivity;
- rare: erythema, acute allergic reaction, lethargy, drowsiness, difficulty falling asleep, sneezing, nasopharyngitis, nasal congestion, dry throat, flu-like condition, decreased sensitivity to stimuli (hypesthesia), pain in the extremities, palpitations, abdominal pain, rash, abnormal skin and mucous membranes, acne, eye pain (ophthalmodenia), unpleasant sensations in the ears, enlarged lymph nodes (lymphadenopathy);
- very rare: chills, taste disorders, loss of taste, burning and tingling sensation (paresthesia), tremor, impaired concentration, nosebleeds (epistaxis), asthma attacks, sore throat, tonsillitis, physical discomfort, neck pain, jaw pain, neck seal, ulcers on the oral mucosa, toothache, esophageal disorders, gastritis attacks, fecal discoloration, eye pain ( ophthalmology), blurred vision, eye irritation, earache, tension sensation, high blood pressure, low blood pressure, urinary incontinence, menstruation delay.
No serious adverse reactions associated with the vaccine were observed.
Storage conditions of the vaccine - in a cooled state at a temperature of from plus 2°C to plus 8°C, protect from light. It should not be frozen.
Shelf life is 24 months. Do not use after the expiration date indicated on the package and on the label.