Immunology and Allergology >>>> Vaccine Gam-COVID-Vac (Sputnik-V) - instructions for use

Vaccine Gam-COVID-Vac (Sputnik-V) - instructions for use.

This instruction has been prepared on the basis of the collected data for the current period and is intended to inform health care workers conducting the vaccination procedure.

This product is registered as a medicinal product (Registration number - LP-006395) for use in conditions of the threat of the spread of a new coronavirus infection (COVID-19) caused by the SARS virus - CoV-2.

Trade name: Gum - COVID - Vac. This is a combination vector vaccine for the prevention of new coronavirus infection (COVID-19).

Dosage form: solution for intramuscular administration. One ampoule (or vial) contains one dose of one of the components. The Gam-COVID-Vac vaccine is a two-component vaccine; vaccination is carried out in two stages - first with Component 1, and then, three weeks later, with Component 2.

Component 1 contains: active substance - recombinant adenoviral particles of 26 serotype, containing the gene of protein S of the SARS virus - CoV-2, in an amount of (1.0 + -0.5) * 10 ¹¹ particles and auxiliary substances - tris (hydroxymethyl) aminomethane - 1210 μg, sodium chloride - 2190 μg, sucrose - 25000 μg, polysorbate - 80-250 μg, magnesium chloride hexahydrate - 102.0 μg, EDTA disodium salt dihydrate - 19.0 μg, ethanol 95% - 0.08 ounces, water for injection up to 0.02 ounces.

Component 2 contains: active substance - recombinant adenoviral particles of serotype 5 containing the gene for the protein S of the SARS virus - CoV-2, in an amount of (1.0 + -0.5) * 10 ¹¹ particles and auxiliary substances - tris (hydroxymethyl) aminomethane - 1210 μg, sodium chloride - 2190 μg, sucrose - 25000 μg, polysorbate - 80-250 μg, magnesium chloride hexahydrate - 102.0 μg, EDTA disodium salt dihydrate - 19.0 μg, ethanol 95% - 0.08 ounces, water for injection up to 0.02 ounces.

The immunological properties and effectiveness of the vaccine were studied in volunteers over 18 years of age of both sexes. Immunization with the drug forms an intense antigen-specific cellular immunity (the formation of antigen-specific cells of both populations of T-lymphocytes: T-helper (CD4 +) and T-cytotoxic (CD8 +) and a significant increase in IFNy secretion). The duration of the protection is unknown. Clinical studies to study the epidemiological effectiveness are ongoing. According to the data of the interim analysis, the efficiency is more than 91%.

Indications for the use of the Gam-COVID-Vac (Sputnik-V) vaccine:

Prevention of new coronavirus infection (COVID-19) caused by the SARS virus - CoV-2 in adults over 18 years of age.

Contraindications to the use of the Gam-COVID-Vac (Sputnik-V) vaccine:

Hypersensitivity to any component.
History of severe allergic reactions.
Acute infectious and non-infectious diseases, exacerbation of chronic diseases - vaccination is carried out 2-4 weeks after recovery or remission. With mild ARVI, acute infectious diseases of the gastrointestinal tract, vaccination is carried out after the temperature has returned to normal.
Pregnancy and the period of breastfeeding (since its effectiveness and safety during this period has not been studied).
Age up to 18 years (due to the lack of data on efficacy and safety).

Contraindications for the administration of Component 2 of the Gam-COVID-Vac vaccine:

Severe post-vaccination complications (anaphylactic shock, severe generalized allergic reactions, convulsive syndrome, body temperature above 104 degrees Fahrenheit (40 degrees Celsius), etc.) for the administration of Component 1 of the Gam-COVID-Vac vaccine.

Method of administration and dosage:

The vaccine is intended for intramuscular administration only. The vaccine is injected into the deltoid muscle (the upper third of the outer shoulder). If it is impossible to inject into the deltoid muscle, the drug is injected into the vastus lateral muscle.

Vaccination is carried out in two stages: first with component 1 at a dose of 0.02 ounces (one ampoule or one bottle), then, three weeks later, with component 2 at a dose of 0.02 ounces (one ampoule or one bottle).

After the administration of the vaccine, the patient should be monitored by medical professionals for 30 minutes.

Side effects of the Gam-COVID-Vac vaccine (Sputnik-V):

Side effects (undesirable effects), predominantly of mild and moderate severity, can develop in the first - second days after the administration of the drug and disappear within the next three days.

More often than other symptoms, short-term general reactions (flu-like syndrome characterized by chills, fever, arthralgia, myalgia, asthenia, general malaise, headache) and local reactions (soreness at the injection site, hyperemia (redness), swelling) can develop. It is recommended to prescribe anti-inflammatory nonsteroidal drugs (NSAIDs) with an increase in temperature after vaccination and antihistamines with a pronounced local reaction.

Less commonly, nausea, dyspepsia, decreased appetite, and sometimes an increase in regional lymph nodes are noted. Some patients may develop allergic reactions, a short-term increase in the level of hepatic transaminases, creatinine and creatine phosphokinase in the blood serum.

In the framework of the conducted clinical studies of the safety, tolerability and immunogenicity of the drug Gam-COVID-Vac after vaccination, the following adverse events were registered:

"General disorders and reactions at the injection site": hyperemia (redness), pain, edema, itching, pyrexia, increased skin temperature at the site of vaccination; decreased appetite, asthenia. The frequency of development is very frequent and frequent.
"Violations of the respiratory system, chest and mediastinal organs": pain in the oropharynx, nasal congestion, sore throat, rhinorrhea. The frequency of development is often.
"Disturbances from the nervous system": headache (often) and dizziness, fainting (rare).
"Gastrointestinal disorders": nausea, vomiting, dyspepsia - often.

"Laboratory and instrumental data" have multidirectional deviations of indicators of immunological status:

An increase in the number of T-lymphocytes;
An increase in the percentage of lymphocytes;
Decrease in the natural number of killer cells;
An increase in the number of CD4 lymphocytes;
Decrease in the number of CD4 lymphocytes;
Increase in the number of B-lymphocytes;
Increase in the natural number of killer cells;
Increase in the number of CD8 lymphocytes;
Increase in the level of immunoglobulin E (IgE) in the blood;
Increased CD4 / CD8 ratio;
Decreased CD4 / CD8 ratio;
Increase in the level of immunoglobulin A (IgA) in the blood;
Decrease in the percentage of CD8 lymphocytes.

"Deviations in the general blood test":

an increase in the percentage of lymphocytes,
decrease in hematocrit,
an increase in the number of lymphocytes,
increased erythrocyte sedimentation rate,
an increase in the number of leukocytes,
an increase in the number of monocytes,
an increase in the number of platelets,
a decrease in the number of neutrophages,
a decrease in the number of platelets.

"Abnormalities in the general analysis of urine": erythrocytes in the urine.

Most of the adverse events ended in complete recovery without consequences. Laboratory deviations had no clinical significance and did not require the use of additional diagnostic procedures and the appointment of therapy.

Overdose cases did not occur due to the fact that the drug is administered only by professionally trained personnel. There are no specific antidotes to the drug. In case of an accidental overdose, more severe toxic and allergic reactions may occur, in which symptomatic therapy will be required according to indications.

Special instructions for the use of the Gam-COVID-Vac vaccine refer to cases when patients have immunosuppressive therapy or have persistent immunodeficiency. These patients may not develop a sufficient immune response. In the case of taking drugs that suppress the immune system (immunosuppressants), patients are discontinued taking these drugs for the period: one month before the moment of vaccination, during the waiting period for the second stage of vaccination and for one month after the last stage of vaccination due to the risk of reducing the immunogenicity of the vaccine.