CoviVac Inactivated whole-virion concentrated, purified coronavirus vaccine (Suspension) Instructions for Use

Marketing Authorization Holder

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Manufactured By

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Packaging and Quality Control Release

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Or

NANOLEK, LLC (Russia)

ATC Code

J07BX03 (COVID-19 vaccines)

Active Substance

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

Dosage Forms

	CoviVac (Inactivated whole-virion concentrated purified coronavirus vaccine)	Suspension for intramuscular injection 0.5 ml/dose: amp. 0.5 ml 10 pcs.
		Suspension for intramuscular injection 0.5 ml/dose: fl. 0.5 ml 10 pcs., 2.5 ml 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular injection homogeneous, white in color, separating upon standing into a colorless transparent liquid and a loose white precipitate.

* obtained by reproduction in a continuous Vero cell line culture.
** is a calculated value.
Does not contain antibiotics or preservatives.

Excipients: aluminum hydroxide – 0.3-0.5 mg, buffer solution (phosphate) (disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections) – up to 0.5 ml.

0.5 ml (1 dose) – ampoules with a volume of 1 ml made from type 1 hydrolytic class glass (10) – cardboard packs^×.
0.5 ml (1 dose) – vials made from type 1 hydrolytic class glass (10) – cardboard packs.
2.5 ml (5 doses) – vials made from type 1 hydrolytic class glass (10) – cardboard packs.

^× when packaging ampoules with a break ring or an opening point, an ampoule knife is not included.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Characteristics. The vaccine is a purified concentrated suspension of SARS-CoV-2 coronavirus strain “AYDAR-1”, obtained by reproduction in a continuous Vero cell line culture, inactivated with beta-propiolactone.

Pharmacological properties. Statistical analysis of the immunological efficacy indicators of the CoviVac vaccine indicates active antibody production after administration of the drug, as well as activation of the cellular arm of the immune response. Clinical trial data indicate that the production of virus-specific antibodies was noted by day 28 after double vaccination in volunteers vaccinated with the CoviVac vaccine. The duration of immunity is unknown. Clinical studies to investigate protective efficacy are ongoing.

Indications

Prevention of the new coronavirus infection (COVID-19) in adults aged 18-60 years.

ICD codes

Dosage Regimen

Vaccinations are carried out in strict compliance with the rules of asepsis and antisepsis.

The vaccine is intended for intramuscular administration only. The vaccine is administered into the deltoid muscle (upper third of the outer surface of the shoulder) twice with an interval of 2 weeks at a dose of 0.5 ml.

Intravenous administration of the drug is strictly prohibited.

The ampoule/vial with the vaccine does not require holding at room temperature. Before injection, the contents of the ampoule/vial are shaken, and the vaccination is carried out immediately after drawing the vaccination dose into the syringe.

The drug in ampoules/vials with damaged integrity and labeling, with changed physical properties (intense coloration, presence of mechanical inclusions), with an expired shelf life, or improper storage is not suitable for use.

Storage of an opened ampoule/single-dose vial is not allowed.

When withdrawing the vaccine from a multi-dose vial by puncturing the rubber stopper with a sterile syringe needle and while observing the rules of asepsis, storage of the unused vaccine for no more than 72 hours is allowed, provided the regulated storage conditions are maintained.

There are no available data on the interchangeability of the CoviVac vaccine (Inactivated whole-virion concentrated purified coronavirus vaccine) with other vaccines for the prevention of COVID-19 to complete the vaccination course. Persons who have received one dose of the CoviVac vaccine (Inactivated whole-virion concentrated purified coronavirus vaccine) should receive the second dose of the same vaccine to complete the vaccination course.

Adverse Reactions

In clinical trials of the CoviVac vaccine and other inactivated vaccines for the prevention of coronavirus infection, the most frequent were local reactions: pain (less than 15% of vaccinations) and induration at the vaccination site (1% of vaccinees), and general reactions: headache (up to 2% of vaccinees) and short-term slight hyperthermia (up to 1%). Reactions of mild severity were more often detected. There were no severe local or systemic reactions to vaccination.

Adverse reactions may appear on days 1-3 after the injection. The duration of reactions usually does not exceed 3 days. The development of allergic reactions, syncopal conditions (reaction to the injection procedure) and lymph node enlargement are also not excluded. The addition of acute (e.g., ARVI, etc.) or exacerbation of chronic infectious diseases, reactivation of chronic infections (e.g., herpes) due to temporary immune stress during vaccination is not excluded.

The adverse effects listed below, based on clinical trial data and post-registration pharmacovigilance, are presented according to the frequency of their occurrence: very common (≥1/10), common (<1/10, ≥1/100), uncommon (<1/100, ≥1/1000), rare (<1/1000, ≥1/10000), very rare (<1/10000), unknown (frequency unknown).

General reactions and reactions at the injection site very common – pain at the injection site; common – induration at the vaccination site; uncommon – swelling, hematoma and itching at the vaccination site, increased body temperature, malaise, decreased appetite; unknown – erythema at the vaccination site, asthenia, feeling unwell, fatigue, chills, feeling hot, sweating.

Nervous system disorders common – headache; uncommon – dizziness; unknown – drowsiness, sleep disorder, paresthesia, hypoesthesia, fainting.

Cardiac disorders unknown – tachycardia.

Gastrointestinal disorders uncommon – nausea, diarrhea.

Musculoskeletal and connective tissue disorders uncommon – myalgia, arthralgia.

Skin and subcutaneous tissue disorders unknown – rash, skin itching.

Immune system disorders unknown – urticaria, angioedema, anaphylactic reaction.

Blood and lymphatic system disorders unknown – lymphadenopathy.

Laboratory and instrumental data uncommon – increased C-reactive protein, CPK, AST, ALT.

Changes in laboratory parameters were not considered as a manifestation of liver damage; no additional examination or treatment was required to normalize the parameters. In general, fluctuations in laboratory parameters did not differ statistically between the vaccine and placebo groups.

Contraindications

1. Serious post-vaccination reaction (temperature above 40°C (104°F), hyperemia or swelling more than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a febrile state) to any previous vaccination in history.
2. Burdened allergic history (anaphylactic shock, angioedema, multiforme exudative erythema, hypersensitivity or allergic reactions to the administration of any vaccines in history, known allergic reactions to vaccine components, etc.).
3. Pregnancy and breastfeeding period.
4. Age under 18 years.

Temporary contraindications

1. Acute febrile conditions, acute infectious and non-infectious diseases, including the convalescence period. Vaccination is carried out 2-4 weeks after recovery. For mild ARVI and acute intestinal infections, vaccination can be carried out after normalization of temperature and/or disappearance of acute symptoms of the disease.
2. Chronic infectious diseases in the acute stage. Vaccination is carried out during the period of remission. The possibility of vaccination for persons suffering from chronic diseases is determined by the attending physician, based on the patient’s condition.

With caution

In chronic diseases of the liver and kidneys, severe disorders of the neuroendocrine system, severe diseases of the hematopoietic system, diseases of the central nervous system (epilepsy, strokes, etc.), cardiovascular system (coronary artery disease, myocarditis, endocarditis, pericarditis), bronchopulmonary system (bronchial asthma, COPD, fibrosing alveolitis, etc.), gastrointestinal tract (with malabsorption syndrome, etc.), immune system (with autoimmune and allergic diseases). The attending physician should assess the benefit-risk ratio of vaccination in each specific case.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and breastfeeding, as its efficacy and safety during this period have not been studied.

Use in Hepatic Impairment

The drug should be used with caution in chronic liver diseases.

Use in Renal Impairment

The drug should be used with caution in chronic kidney diseases.

Pediatric Use

Contraindicated for use under the age of 18 years.

Special Precautions

Inactivated vaccines are not contraindicated in patients with immunosuppressive or immunodeficient conditions. There are no clinical data on the use of the medicinal product in this category of patients.

In patients receiving immunosuppressive therapy and patients with immunodeficiency, a sufficient immune response may not develop. 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.

Locations where vaccination is carried out must be equipped with anti-shock therapy means in case of anaphylaxis or other severe hypersensitivity reaction after vaccine administration in accordance with the Order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1079n “On approval of the standard of emergency medical care for anaphylactic shock”.

To identify contraindications on the day of vaccination, the patient must be examined by a doctor: questioning, general examination and body temperature measurement are mandatory; if the body temperature exceeds 37°C (98.6°F), vaccination is not carried out.

The vaccinated person must be under medical supervision for at least 30 minutes after vaccination.

The vaccination performed is recorded in the established accounting forms indicating the name of the drug, date of vaccination, dose, batch number, reaction to the vaccination. Similar to other vaccines, a protective immune response may not occur in all vaccinated individuals.

Influence on the ability to drive vehicles and mechanisms

Studies on the effect of the vaccine on the ability to drive vehicles and potentially dangerous mechanisms have not been conducted.

Overdose

The potential risk of overdose has not been studied. The use of the medicinal product is allowed by qualified medical personnel in the conditions of medical and preventive institutions, the risk of overdose is extremely low.

Drug Interactions

Not studied.

Due to the lack of compatibility study data, the CoviVac vaccine (Inactivated whole-virion concentrated purified coronavirus vaccine) cannot be mixed with other vaccines or other medicinal products in the same syringe.

Storage Conditions

The drug should be stored out of the reach of children at a temperature of 2 to 8°C (46.4°F) inclusive. Freezing is not allowed.

Transport conditions In accordance with SanPiN 3.3686-21 at a temperature of 2 to 8°C (46.4°F) inclusive. Freezing is not allowed.

Shelf Life

Shelf life – 1 year. Do not use after the expiration date stated on the packaging.

Dispensing Status

For medical and preventive institutions.

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.