Cuba attributes 91.2 % efficacy to its Soberana 02 Covid vaccine candidate with extra dose

RIO DE JANEIRO, BRAZIL – Cuba’s Finlay Vaccine Institute (IFV) reported Thursday the combination of two doses of its candidate vaccine Soberana 02 with a booster dose of Soberana Plus had shown 91.2% efficacy against SARS-CoV-2, which causes Covid-19.

Soberana 02 and Soberana Plus – developed by the IFV – are two of the five vaccine projects against the coronavirus being investigated by Cuban scientific institutions.

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Preliminary analyses of the third and last phase of clinical trials of Soberana 02 – conducted with 44,010 volunteers – had shown a 62% efficacy of this subunit conjugate vaccine formulation that combines the virus antigen and tetanus toxoid to stimulate the immune system response.

In the case of Soberana Plus, it includes two receptor-binding domains (RBDs) linked together with aluminum hydroxide. It is the only vaccine project being studied in the Covid-19 convalescent population.

The director of the Finlay Institute, Vicente Vérez, explained that the efficacy of the three-dose scheme was determined in the presence of the South African Beta variant of SARS-CoV-2 when presenting this new research result to Cuban President Miguel Díaz-Canel, according to Cuban state media.

The World Health Organization (WHO) establishes that for a vaccine candidate to be considered a vaccine, it must demonstrate an efficacy equal to or greater than 50%.

Based on these results, the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed) -Cuba’s regulatory body- can officialize the registration of Soberana 02 plus Soberana Plus as a vaccine and issue an authorization for its emergency use for future mass vaccination of the Cuban population.

Abdala, another of the Cuban anti-covid vaccine candidates, developed by the Center for Genetic Engineering and Biotechnology (CIGB), showed an efficacy of 92.2% with three doses in the analyses of the final phase of clinical trials in adults, for which Cecmed has been requested its authorization for emergency use.

The first of the two vaccines to obtain this authorization is expected to become the first vaccine against coronavirus developed in Latin America.

Clinical trials are currently being carried out with Soberana 02 and Abdala to evaluate the safety and immunogenicity of these formulas in Cuban children and adolescents.

More than one million of the 11.2 million Cubans have received the full regimen of these formulas as part of the clinical trials and intervention studies developed in parallel to the health care one.