Characteristics of the Cuban Vaccine for COVID 19 Soberna 02

SUMMARY OF PRODUCT FEATURES

Product name: SOBERANA® 02. (Protein subunit anti-COVID-19 conjugate vaccine)
Pharmaceutical form: Suspension for IM injection
Strength: 25 μg / 0.5 mL.
Presentation: Case of 25 colorless glass bulbs with 10 doses each
Name of the holder of the Emergency Use Authorization: INSTITUTO FINLAY DE VACUNAS, Havana, Cuba.
Product manufacturer(s), city(ies), country(ies):
1. CENTER FOR MOLECULAR IMMUNOLOGY, Havana, Cuba. Therapeutic Antibody Production Plant (ANTYTER).
Biological Material Purified antigen: Recombinant protein from the receptor binding domain of the SARS-CoV-2 virus
2. FINLAY INSTITUTE OF VACCINES, Havana, Cuba.
Department of Production of Active Pharmaceutical Ingredients DPT
Biological Material Carrier protein: Purified Tetanus Anatoxin.
Department of Production of Active Pharmaceutical Ingredients 1 and 2, Block for obtaining conjugates Active pharmaceutical ingredient.
3. NATIONAL CENTER FOR BIOPREPARATIONS, Bejucal, Cuba.
Parenteral Products Plant 2
Formulation and filling.
Packaging Plant
Container
Product with Emergency Use Authorization issued by CECMED
No. of Authorization of Use in
Emergency: Resolution No.144/2021
Authorization Issuance Date: August 20, 2021
Therapeutic indications: SOBERANA® 02 is indicated for the prevention of symptomatic disease caused by the virus
SARS-CoV-2 in people 2 years of age or older.
Contraindications: It should not be administered to people with known hypersensitivity to any component of the vaccine.

Precautions:

The vaccine should not be given to people who have experienced a severe allergic (anaphylactic) reaction with the previous dose.
Appropriate medical supervision and treatment should always be available in the event of an anaphylactic reaction.
Close observation is recommended for at least 15 minutes after vaccination, or for the period of time required by the corresponding health authority.
People with chronic, autoimmune or endocrine-metabolic diseases must be compensated at the time of vaccination.
It should not be administered to patients with feverish states, or acute illnesses, waiting for the improvement of the clinical picture to start or continue treatment.
Taking vital signs before vaccination is recommended; in case of high blood pressure, it is suggested to defer immunization until blood pressure control is achieved. The efficacy of the vaccine may be less in immunosuppressed or immunodeficient people.
If the person has recently received tetanus vaccination, they should wait 30 days before administering SOBERANA® 02.

Composition:

Each 0.5 mL dose contains:
SARS-CoV-2 virus receptor binding domain (RBD) recombinant protein
Monomeric) conjugated to tetanus toxoid ….………25 μg
Thiomersal……………… 0.05mg
Aluminum hydroxide gel
Sodium chloride
Disodium hydrogen phosphate
Sodium dihydrogen phosphate dihydrate
Water for injection

Validity period: 6 months
Storage Conditions: Store at 2-8°C. Do not freeze.

Special warnings and precautions for use:

Convalescents from COVID-19 must follow the approved vaccination protocol for these cases.
People may not be fully protected for up to 14 days after the last dose of the recommended schedule.
As with other vaccines, SOBERANA® 02 may not protect everyone who receives it, therefore, those vaccinated should not violate the anti-epidemic measures recommended by national health authorities.
Contains thiomersal as a preservative, may cause allergic reactions.
Do not inject the vaccine intravascularly, subcutaneously, or intradermally.

Undesirable effects:

Hundreds of thousands of doses of vaccine have been applied. The adverse reactions identified are mainly mild or moderate and resolve completely within a few days of vaccination.
The most frequent adverse reactions are local.
Common (1-10%): injection site pain
Uncommon (<1%): swelling, local warmth and erythema at the injection site.
Uncommon (<1%) systemic adverse reactions may occur such as malaise, fever and rash.
Rare reactions with a very low frequency of appearance are erythema multiforme and angioneurotic edema.
No deaths have been reported in which the cause of death was related to the application of the product.

Dosage and mode of administration:

SOBERANA® 02 should be administered with a basic schedule of two doses of 0.5 mL intramuscularly, preferably in the Deltoid muscle, with a minimum interval between doses of 28 days.
at 28 days after completing the basic two-dose schedule, a third dose of 0.5 mL, intramuscularly, of the SOBERANA®-Plus vaccine will be applied as a booster.
The time interval between doses should not be shortened. Occasionally it may be necessary to administer a dose before the scheduled time, recommending up to 4 days before the scheduled age or the established interval between doses.
If the interval between doses is prolonged, a new regimen should not be started, regardless of the time that has elapsed since the application of the previous dose.
In all cases, the vaccinator will consult the recommendations, issued by the health authorities, for the administration of vaccines in the campaign.

Interactions with other medicinal products and other forms of interaction:
No interaction studies have been performed.
Co-administration with other vaccines has not been studied.
During clinical investigations of this product, no evidence of drug interactions was detected.
The efficacy of vaccination may be affected in patients receiving immunosuppressive therapy.
In cases of non-prolonged immunosuppressive treatment, the possibility of postponing vaccination until one month after the end of said treatment should be considered.

Use in pregnancy and lactation:
Experience with the use of this vaccine in pregnant women is limited.
Teratogenicity studies in experimental animals have shown no toxic effects on reproduction or offspring.
Administration of these vaccines during pregnancy should only be considered if, in medical judgment, the known or potential benefits outweigh the known or potential risks to the mother and fetus.
Termination of pregnancy is not necessary in the case of vaccination of a woman whose pregnancy status is unknown. There is insufficient evidence to contraindicate its use in lactating women.

Effects on the driving of vehicles and machinery: They have not been reported to date.
Overdose: No cases of overdose have been reported.
In case of overdose, monitoring of vital functions and possible treatment is recommended.
symptomatic.

Pharmacodynamic properties:
ATC code: J07BX
Pharmacotherapeutic group: J - Antiinfectives for systemic use, J07 - vaccines, J07B - antiviral vaccines, J07BX - other antiviral vaccines.
The SOBERANA® 02 vaccine is made up of the receptor binding domain known as RBD (receptor binding domain) of the S protein of the SARS-CoV-2 virus, conjugated to the Toxoid
Tetanic and adjuvanted with aluminum hydroxide.
This protein S receptor-binding domain of the virus constitutes the region through which the virus interacts with the ACE2 receptor (angiotensin-converting enzyme 2) and plays a fundamental role in the entry of the virus into host cells. It has been shown that this protein is the main target of the neutralizing antibodies induced against the virus in natural infection.

The conjugation of RBD to tetanus toxoid significantly increases the ability of the vaccinated individual's immune system to produce high titers of neutralizing antibodies against the virus. During clinical trials, it was shown that two doses of SOBERANA® 02 applied at intervals of 28 days induce a specific antibody response against RBD in 76% of vaccinated individuals, and it increases to 96% when a dose of SOBERANA® 02 is administered. reinforcement
of SOBERANA-Plus 28 days after the second dose of SOBERANA® 02.
Additionally, it was shown that a specific T-cell response is induced, which complements the protective immune response in vaccinated individuals.
The schedule of two doses of SOBERANA02 at an interval of 28 days demonstrated a clinical efficacy of 65% in the prevention of symptomatic disease by SARS-Cov-2.
The schedule of two doses of SOBERANA02 and a booster dose of Soberana-Plus at 28-day intervals demonstrated a clinical efficacy of 91.2% in the prevention of symptomatic SARS-Cov-2 disease.

Pharmacokinetic properties: Not applicable.

Instructions for use, handling and destruction of the unusable remainder of the product:

Visual inspection of the bulb is recommended prior to administration.
It is prohibited to use the bulb with evidence of violation of its physical integrity (of the container-closure system) or in case of changes in physical properties (color, transparency, appearance of particles, precipitates).
Gently shake the contents of the bulb before extracting each dose, to ensure proper homogeneity.
Once the bulb has been punctured, it must be kept protected from light and stored at a temperature of 2 to 8 °C, it must not be used once the work session is over and the remnants must be discarded.
If the amount of vaccine remaining in the bulb cannot provide a full dose, discard