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

Nasal drops 0.5 ml/dose

Dosage Form, Packaging, and Composition

Nasal drops

0.5 ml (1 dose) – vials (10 pcs.) – cardboard packs – for medical and preventive 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

It consists of purified recombinant virus-like particles composed of four structural proteins S, M, N, E of SARS-CoV-2, synthesized in a baculovirus expression system.

The virus-like particles mimic the SARS-CoV-2 virion but do not contain nucleic acids and therefore do not replicate in the body. The surface S protein in the composition of the virus-like particles is represented by the 19A, Alpha, Delta, and Omicron variants.

It induces the formation of local, cellular, and humoral immunity against coronavirus infection caused by SARS-CoV-2. The vaccine is a single component, administered three times with an interval of 21 days.

Immunogenicity

Intranasal administration of the drug induces a humoral (increase in titers of IgA antibodies, IgG antibodies, virus-neutralizing antibodies in the blood) and cellular immune response to the coronavirus infection caused by the SARS-CoV-2 virus. When assessing the local immune response, a statistically significant increase in specific secretory IgG antibodies was observed over time.

The maximum indicators of the local immune response were observed on day 21 after double administration and on day 10 after triple administration of this vaccine.

The protective antibody titer is currently unknown. The duration of protection is unknown.

Indications

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

ICD codes

Dosage Regimen

For intranasal administration only.

Use the provided dosing device for administration.

Administer the vaccine three times.

Maintain an interval of 21 days between each dose.

Ensure the patient is in a seated position with the head tilted slightly back.

Insert the device tip into one nostril and administer the full 0.5 ml dose.

Do not administer the vaccine in the presence of an active nasal infection or significant nasal congestion.

Do not use if the vial has been previously frozen and thawed more than once.

Complete the full three-dose vaccination course to ensure development of a protective immune response.

Adverse Reactions

Musculoskeletal system disorders infrequently – myalgia.

Respiratory system disorders infrequently – rhinorrhea; very rarely – oropharyngeal pain, nasal congestion, throat irritation.

Nervous system disorders frequently – headache; very rarely – dizziness.

Gastrointestinal system disorders infrequently – diarrhea.

General disorders frequently – fatigue; infrequently – chills, pyrexia; very rarely – asthenia.

Laboratory and instrumental data infrequently – increased INR, increased blood IgE level, increased C-reactive protein level, increased leukocyte count, increased neutrophil count, decreased lymphocyte count, increased lymphocyte count; very rarely – decreased hemoglobin level, increased platelet count.

Contraindications

Hypersensitivity to the components of the vaccine used; 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 groups of patients: 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.

Use in Hepatic Impairment

Vaccination should be carried out with caution in chronic liver diseases.

Use in Renal Impairment

Vaccination should be carried out with caution in chronic kidney diseases.

Pediatric Use

Contraindication: age over 55 years (due to the lack of data on efficacy and safety in persons over 55 years).

Geriatric Use

Contraindication: age under 18 years (due to the lack of data on efficacy and safety in persons under 18 years).

Special Precautions

Patients with immunodeficiency may not develop a sufficient immune response.

As with other immunobiological medicinal products, a protective immune response may not be induced in all vaccinated individuals.

Drug Interactions

Patients receiving immunosuppressive therapy 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.

Storage Conditions

Store at below -18 °C. 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.