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