Product name: ABDALA 50 μg (Protein subunit anti-COVID-19 vaccine)
Pharmaceutical form: Suspension for IM injection.
Strength: 50 μg / 0.5 mL.
Presentation: Case of 10 colorless glass bulbs with 5 mL each.
Name of the holder of the Emergency Use Authorization. CENTER FOR GENETIC ENGINEERING AND BIOTECHNOLOGY, Havana, Cuba.
Manufacturer(s) of the product.
1. CENTER FOR GENETIC ENGINEERING AND BIOTECHNOLOGY, Havana, Cuba.
2. AICA LABORATORIES COMPANY, Havana, Cuba, BASE BUSINESS UNIT (UEB) AICA.
Product with Emergency Use Authorization issued by CECMED
Emergency Use Authorization No.: Resolution No. 202/21.
Authorization Issuance Date: October 27, 2021
Composition:
Each 0.5 mL dose contains:
Therapeutic indications:
ABDALA is indicated for specific active immunization against SARS-CoV-2 infection, in adults and children from 2 years of age.
Contraindications:
It should not be administered to people with known hypersensitivity to any of the components of the vaccine.
Precautions:
The efficacy of the vaccine may be less in immunocompromised or immunodeficient persons.
In individuals who report acute infection in the last 15 days, inoculation with ABDALA should be postponed until resolution of said infection.
Special warnings and precautions for use:
Undesirable effects:
Accumulated clinical experience shows that after the application of the ABDALA vaccine in adults, the adverse reactions that occur are mostly mild and subside spontaneously without pharmacological treatment, with a greater occurrence in the first 24-48 hours after administration of the vaccine. .
The frequency of recording of adverse reactions is greater after the application of the first dose of the vaccination scheme and decreases after the application of subsequent doses.
After evaluating the safety after the application of 215,267 doses in the intervention clinical trial in risk cohorts, the safety profile previously found in the clinical development of the product is confirmed.
The frequency of appearance of adverse reactions in adults is low, between 0.1 and 1% of the total applied dose, mainly local, with predominance of pain, in addition to erythema and induration (0.85%).
Systemic adverse reactions include headache (0.54%), drowsiness (0.18%) and asthenia (0.14%).
Other adverse reactions that occur with a frequency of less than 0.1% of applied doses have been described, such as nausea, vomiting, arthralgia and malaise.
In the pediatric population (2-18 years) evaluated in clinical trials, pain at the injection site was the only frequent or common local adverse reaction (≥ 1% and < 10%). Other local adverse reactions were infrequent (≥ 0.1% and < 1%), such as redness (0.88%) and induration (0.70%).
Among the systemic adverse reactions, those reported as frequent were:
Dosage and mode of administration:
ABDALA is administered by intramuscular injection in the deltoid region, in three doses of 0.5 mL, with an interval between applications of 14 days.
The time interval between doses should not be shortened.
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:
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development.
The administration of ABDALA in pregnant and postpartum women who are lactating has been well tolerated, accumulating in each group a total of 139,517 and 183,062 doses applied, respectively, without serious adverse events related to the vaccine being reported.
Administration during pregnancy should be considered, based on medical judgment, if 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.
Effects on driving vehicles / 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 symptomatic treatment is recommended.
Pharmacodynamic properties:
ATC code: J07BX
Pharmacotherapeutic group: J - Antiinfectives for systemic use, J07 - vaccines, J07B - antiviral vaccines, J07BX - other antiviral vaccines.
ABDALA's active ingredient is the recombinant RBD protein (SARS-CoV-2 virus receptor binding domain) that allows interaction with ACE2, its receptor in human cells, a molecule that has been expressed in Pichia pastoris yeast, adjuvanted in aluminum hydroxide.
Antigenicity is a fundamental characteristic for vaccine antigens. In the case of RBD, this element is defined by its binding to the ACE-2 receptor itself and the production of antibodies that recognize conformational epitopes that are essential for the efficient neutralization of human cell infection by the SARS-CoV-2 virus. that can contribute to protection against COVID-19.
In Phase I/II clinical studies in 792 volunteers, ABDALA has generated a high level of seroconversion of anti-RBD antibodies in more than 90% of vaccinated individuals, aged between 19 and 80 years of age, just 14 days after vaccination. last immunization.
The functionality of the induced antibodies has also been evidenced, with a positive correlation in assays for the inhibition of binding to the SARS-CoV-2 virus receptor and in viral neutralization studies.
In the Phase III clinical study of vaccine efficacy in 48,290 volunteers (multicenter, randomized, double-blind, placebo-controlled), ABDALA demonstrated an efficacy of 92.28% in reducing the risk of suffering from symptomatic disease due to COVID-19.
In the pediatric population aged 3 to 18 years, ABDALA showed a seroconversion of 98.7%.
The results of a clinical trial, which evaluated the immunogenicity of this vaccine applied with a 3-dose schedule in ages between 3 and 18 years, compared with those of a similar trial conducted with the same vaccine and schedule, which showed its efficacy, in a population between 19 and 29 years of age (Immunobridge), showed similar results in all immunological variables.
Pharmacokinetic properties (absorption, distribution, biotransformation, elimination): Not applicable.
Instructions for use, handling and destruction of the remainder does not use Product description:
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 the bulb with the remaining volume.
An additional overfill is included in each bulb to ensure that 10 doses of 0.5 ml can be delivered.
Do not combine the leftover volume of vaccine from several bulbs.
An individual sterile syringe and needle should be used for each injection to avoid transmission of infectious agents from one individual to another.
The correct handling and extraction by the medical staff of one or more doses of vaccine, in a multidose bottle, guarantees the quality of the product.
The producer is not responsible for non-compliance with the recommendations for handling and storing the vaccine.
This vaccine cannot be used after its expiration date.
Date of approval / revision of the text: 2021-11-08.
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