EFE.- The Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed) approved today the emergency use of Soberana 02 and Soberana Plus, prepared by the state Finlay Vaccine Institute (IFV).
These formulas showed 91.2% efficacy in clinical trials when combining two doses of Soberana 02 and a booster dose of Soberana Plus.
For a vaccine candidate to be considered a vaccine, it must show an efficacy equal to or greater than 50%, according to the World Health Organization (WHO).
In this way, the Caribbean country has three own formulas against the SARS-CoV-2 that causes Covid-19, after Abdala, developed by the Center for Genetic Engineering and Biotechnology, reached an efficacy of 92.2% with three doses in the final phase of studies.
Sovereign 02 is a subunit conjugated formula that combines virus antigen and tetanus toxoid to stimulate the immune system response.
In the case of Soberana Plus, it includes two receptor-binding domains (RBD) linked together with aluminum hydroxide. It is the only project that is applied to the convalescent population of Covid-19.
The director of the IFV, Vicente Vérez, explained in July when he showed the results of the study that the efficacy in the three-dose scheme was determined in the presence of the South African variant Beta of SARS-CoV-2.
THE NEXT STEP
“It has been 444 days of a very great effort” until today since May 19, 2020, when President Miguel Díaz-Canel requested a preventive vaccine against Covid-19, assured Vérez, the Cuban scientist who led the study of the Sovereigns .
What follows now is to request authorization to extend the trials to the population of pediatric ages, he told state television, stressing that “although we have not finished, it is a very important step forward.”
For her part, the director of the Cuban drug regulatory entity, Olga Lidia Jacobo, announced that a formulation of Soberana 02 and Soberana Plus without thiomersal was also approved for people allergic to this compound.
CUBA AT THE WORST TIME OF THE PANDEMIC
The two new vaccines arrive at a complex time for Cuba due to Covid-19, which has been reflected in an average of 8,000 cases and 70 daily deaths.
The Caribbean country, of 11.2 million inhabitants, has the highest incidence rate of the disease in America and one of the highest in the world with 1,173 infections per 100,000 inhabitants in the last 15 days, according to the Ministry of Public Health (Minsap ).
The total of positives to SARS-CoV-2 since March of last year is 564,011; Meanwhile, deaths total 4,397, after the 78 confirmed in the last 24 hours by the Ministry of Health.
The island has had to cope with the pandemic under the effects of the United States’ economic embargo, a shortage of medicines, a lack of oxygen, its overcrowded hospitals and collapsed funeral services.
The goal set by the health authorities was to immunize the entire population in 2021.
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Since May, a study of health intervention in risk areas has been underway, while the safety and immunogenicity in Cuban children and adolescents are evaluated.
More than three million people have already received the complete regimen of the three necessary doses of Abdala, Soberana 02 and Soberana Plus as part of that study and of the clinical trials carried out in parallel to measure the efficacy of the now vaccines.
Cuba does not integrate the WHO Covax mechanism for low- and middle-income nations to purchase vaccines, nor did it purchase them on the international market.
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