Cuba announced that its Sovereign 02 vaccine reached 62% effectiveness against COVID-19 in preliminary studies

The vaccine candidate Sovereign 02 against the coronavirus, developed by the Finlay Vaccine Institute (IFV) of Cuba, has shown a 62% efficiency in the preliminary analyzes of the third phase of clinical trials, the scientists responsible for the research reported on Saturday.

The director of the IFV, Vicente Vérez, clarified on public television that the percentage was obtained from the interim analysis of the results in the volunteers to which they were applied. two doses of Sovereign 02 28 days apart.

This formulation, one of five studied in Cuba, is a subunit conjugate vaccine – traditionally very safe – that combines viral antigen and tetanus toxoid to stimulate the immune system response.

Vérez called the result “very heartwarming” as it was obtained in a circulation scenario of “variants of most concern because of their transmissibility”.

He also pointed out that These results meet the requirements of the World Health Organization (WHO) to consider a candidate under study as an “effective vaccine”, since this organization establishes a minimum efficacy of 50%.

IFV scientists have argued that in the coming days an emergency use authorization will be requested from Soberana 02 to the National Control Center for Drugs, Equipment and Medical Devices (CECMED), the regulatory body in Cuba.

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

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

Sovereign Plus booster analysis

Once the preliminary results of the efficacy of the two-dose administration schedule have been known, it remains to know that of the second schedule used in clinical trials, consisting of two doses of Soberana 02 and one dose of Soberana Plus.

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

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

A third phase of studies was also carried out in parallel in Iran, under an agreement with the Institut Pasteur of this country, which has just announced that at the beginning of next week it could authorize its emergency use – there the Cuban formula was baptized Pasteur -.

This week, the clinical trial of Soberana 02 also began in pediatrics, initially with a group of minors from 12 to 18 years old.

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 effectiveness should also be known shortly.

Soberana 02 and Abdala have already been administered to tens of thousands of Cubans in health intervention studies and in parallel with 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 World Health Organization’s Covax mechanism created to provide low- and middle-income countries with access to vaccines, and has not purchased them on the international market.

The news comes as the largest Caribbean island faces its worst outbreak since the start of the pandemic following the arrival of more contagious variants, which have set new records for daily coronavirus cases. However, daily cases have been halved in the capital since the start of this vaccination campaign, according to official data, although this could also be due to the stricter measures.

Some 4,328,291 doses of Soberana 02 and Abdala were administered up to June 16. Some 2,145,685 people received one dose, while 1,389,480 received the second dose and 793,126 the third. The regime chaired by Miguel Díaz Canel aims to vaccinate 70% of the 11.2 million inhabitants in August and the entire population before the end of the year.

(With information from EFE, AFP and Reuters)

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