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Potential Cuban vaccine “Soberana 02” shows 62% efficacy in trials

The Sovereign 02 vaccine candidate against coronavirus, developed by the Finlay Vaccine Institute (IFV) of Cuba, showed an efficacy of 62% in the preliminary analyzes of the third phase of clinical trialsThe scientists responsible for the research reported this Saturday.

The director of the IFV, Vicente Vérez, specified on state television that the percentage has been obtained from the intermediate analysis of the results in the volunteers to whom they were applied two doses of Sovereign 02 28 days apart.

This formula, one of the five being investigated in Cuba, is a subunit conjugate vaccine -traditionally very safe- that combines virus antigen and tetanus toxoid to stimulate the response of the immune system.

Vérez described as “very comforting“the result, because it has been obtained in a scenario of circulation” of the most worrying variants due to their transmissibility “.

He also stressed that with these results meet the requirements of the World Health Organization (WHO) to consider a candidate under study as an “effective vaccine”, since that organism establishes a minimum efficacy of 50%.

IFV scientists advanced that in In the next few days, the authorization of emergency use of Soberana 02 will be requested from the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), the regulatory body in Cuba.

Once approved for emergency use, Soberana 02 would officially acquire the category of vaccine and would become the first against Covid-19 developed in Latin America.

The result announced today was obtained by an interdisciplinary, independent scientific committee, with professionals from the Pedro Kourí Institute of Tropical Medicine, the Center for Molecular Immunology and the Ministry of Public Health.

WAITING FOR THE RESULTS OF THE PARALLEL VACCINATION SCHEME

Once the preliminary efficacy results of the two-dose schedule are known, It remains to be seen that of the second scheme used in clinical trials, consisting of two doses of Soberana 02 and one dose of Soberana Plus.

According to Vérez, they hope to have this data in about two weeks, and that the efficacy achieved by this three-dose scheme is higher than the 67% obtained by the two-dose scheme.

The third phase of clinical trials of Soberana 02, carried out entirely in Havana with a double-blind protocol and placebo group, included 44,010 volunteers aged 19 to 80 years.

It was also carried out in parallel a third phase of studies in Iran, by virtue of an agreement with the Pasteur Institute of that country, which has just announced that at the beginning of next week it could authorize its emergency use – there the Cuban formula has been baptized as Pasteur-.

This week also began the clinical trial of Soberana 02 in pediatric ages, initially with a group of children between 12 and 18 years old.

Congratulations Cuba. On the eve of Father’s Day and 13 months of searching for a Cuban vaccine, it is confirmed that with 2 doses, Soberana02 reached a good percentage of efficacy. We will soon know the data with the third dose of SoberanaPlus, which must be higher, “wrote on Twitter the Cuban President, Miguel Díaz-Canel.

Cuba has a second vaccine candidate in the last phase of clinical trials, Abdala, developed by the Center for Genetic Engineering and Biotechnology, and whose efficacy is also expected to be known shortly.

Both Soberana 02 and Abdala have already been administered to tens of thousands of Cubans under the figure of health intervention studies and in parallel to clinical trials.

According to official figures, just over two million Cubans, out of a population of 11 million, have received at least one dose of these formulas.

Cuba is not a member of the Covax Mechanism of the World Health Organization created for low- and middle-income countries to access vaccines, nor has it purchased them on the international market.

The country, which has been going through the third and worst wave of infections since January, has accumulated 166,368 infections and 1,148 deaths from covid-19 to date.

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