Gam-VLP-multivac, virus-like particle vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus (Emulsion) Instructions for Use

Marketing Authorization Holder

FSBI N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation (Medgamal Branch of the N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation) (Russia)

ATC Code

J07BN05 (COVID-19 vaccine, virus-like particles)

Active Substance

Vaccine for the prevention of COVID-19 (Grouping name)

Dosage Form

Gam-VLP-multivac, virus-like particle vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus

Emulsion for intramuscular administration 0.5 mL/dose

Dosage Form, Packaging, and Composition

Emulsion for intramuscular administration

0.5 ml (1 dose) – vials (10 pcs.) – cardboard packs – for healthcare institutions

Clinical-Pharmacological Group

Vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus

Pharmacotherapeutic Group

MIBP-vaccines; viral vaccines; COVID-19 vaccines

Pharmacological Action

The vaccine induces the formation of T-cell and humoral immunity against coronavirus infection caused by SARS-CoV-2.

Maximum immunogenicity indicators in enzyme-linked immunosorbent assay (ELISA) and neutralization assay (NA) were observed as early as 21 days after the first vaccination, with the exception of the Omicron strain, for which double vaccination showed higher immunological efficacy.

Analysis of immunogenicity showed that this vaccine is immunogenic and allows for the formation of virus-neutralizing antibodies.

Assessment of the T-cell immune response showed that this vaccine can be an inducer of a cell-mediated immune response with cytokine production insufficient for the development of immunopathological conditions associated with excessive production of the studied pro-inflammatory cytokines. The protective antibody titer is currently unknown. The duration of protection is unknown.

Indications

Prevention of coronavirus infection (COVID-19) in adults aged 18 to 55 years.

ICD codes

Dosage Regimen

Administer the vaccine intramuscularly into the deltoid muscle.

The full vaccination course consists of two doses of 0.5 mL each.

Maintain a 21-day interval between the first and second dose.

Do not mix this vaccine with other vaccines or medicinal products in the same syringe.

Inspect the vial visually for particulate matter and discoloration prior to administration.

Discard the vaccine if it appears discolored or contains visible particles.

Use a separate, sterile syringe and needle for each injection.

Do not administer intravenously, intradermally, or subcutaneously.

Adhere strictly to the recommended two-dose schedule to ensure optimal immunogenicity.

Complete the primary immunization course regardless of a history of prior SARS-CoV-2 infection.

Shake the vial gently before use to obtain a homogeneous emulsion.

Puncture the rubber stopper of the vial only once and withdraw the 0.5 mL dose immediately.

Adverse Reactions

Musculoskeletal system disorders very common – myalgia; very rare – arthralgia.

Nervous system disorders very common – headache; very rare – dizziness.

Skin and subcutaneous tissue disorders very rare – rash.

Respiratory system disorders very rare – oropharyngeal pain, cough, nasal congestion, rhinorrhea – very rare.

Gastrointestinal system disorders very rare – abdominal pain, vomiting; rare – diarrhea, nausea.

General disorders common – fatigue, chills; uncommon – pyrexia.

Local reactions very common – pain at the vaccination site; common – induration and swelling at the vaccination site; uncommon – itching and erythema at the vaccination site.

Laboratory and instrumental data very rare – increased blood bilirubin level, increased platelet count, erythrocytes in urine, increased platelet count, decreased platelet count, decreased neutrophil count, protein in urine, decreased hemoglobin level, increased lymphocyte count, decreased lymphocyte count, increased leukocyte count, leukocytes in urine, decreased leukocyte count, increased ESR, increased blood glucose level, increased ALT activity; rare – increased C-reactive protein level, increased AST level, increased blood immunoglobulin E (IgE) level, increased blood CPK level.

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Contraindications

Hypersensitivity to this vaccine; 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. For non-severe acute respiratory viral infections, acute infectious gastrointestinal diseases – vaccination is carried out after temperature normalization; pregnancy, breastfeeding period; age under 18 years and over 55 years (due to the lack of data on efficacy and safety in persons under 18 years and over 55 years).

With caution

Vaccination should be carried out with caution in chronic diseases of the liver and kidneys, endocrine diseases (severe thyroid dysfunction and decompensated diabetes mellitus), severe diseases of the hematopoietic system, epilepsy and other diseases of the central nervous system, acute coronary syndrome and acute cerebrovascular accident, myocarditis, endocarditis, pericarditis.

Due to lack of information, vaccination may pose a risk for the following patient groups: with autoimmune diseases (stimulation of the immune system may lead to an exacerbation of the disease, special caution should be exercised in patients with autoimmune pathology prone to the development of severe and life-threatening conditions); with malignant neoplasms.

The decision to vaccinate should be based on an assessment of the benefit-risk ratio in each specific situation.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in persons under 18 years of age due to the lack of data on efficacy and safety.

Geriatric Use

Contraindicated for use in persons over 55 years of age due to the lack of data on efficacy and safety.

Special Precautions

Patients receiving immunosuppressive therapy and patients with immunodeficiency may not develop a sufficient immune response, therefore the use of drugs that suppress the function of the immune system is contraindicated for at least 1 month before and after vaccination due to the risk of reduced immunogenicity.

As with other vaccines, a protective immune response may not develop in all vaccinated individuals.

Drug Interactions

No specific drug interaction studies have been conducted.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.