Pharmaceutical Industry Information Portal

Cuban Soberana 02 vaccine against the coronavirus shows 62% efficacy

The Soberana 02 vaccine candidate against the coronavirus, developed by Cuba’s Finlay Vaccine Institute (IFV), showed a 62% efficacy in the preliminary studies of the third phase of clinical trials, the 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 study of the results in the volunteers to whom two doses of Soberana 02 were applied 28 days apart.

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

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

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

The IFV scientists advanced that in the coming 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 COVID-19 vaccine developed in Latin America.

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 between 19 and 80 years

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.


Expert Articles