Cuba: Protocol Compliance Evaluated in COVID Vaccine Trials

The president of the Business Group of the Biotechnological and Pharmaceutical Industries of Cuba (BioCubaFarma), Eduardo Martínez, and several experts visited vaccination centers in this city where the clinical trials are being carried out.

At the 27 de Noviembre polyclinic in the capital's Mariano municipality, Dr. Vicente Vérez, director of the Finlay Vaccine Institute (IFV), the leading institution of this project, thanked the volunteers for their participation in the study.

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He also thanked the public health and University of Havana personnel who organized and coordinated the healthcare unit trials.

Phase III clinical trials of Soberana 02 began in early March with a sample of 44,10 volunteers from eight municipalities in this province, which has the highest incidence rate of positive cases.

This stage is expected to end on November 7, 2021, and the results will be available as of January 15, 2022.

It is a multicenter, adaptive, parallel-group, randomized, placebo-controlled, double-blind trial for which the municipalities were selected: Playa, Plaza, Diez de Octubre, Centro Habana, Marianao, Habana Vieja, Cerro, and La Lisa.

Phase III's efficacy will be evaluated in two schemes: one of two doses of Soberana 02 and another of two doses with a third booster dose of Soberana Plus (another candidate developed by the IFV).

"The application of the first dose of the anti-COVID-19 Soberana 02 vaccine candidate, in its phase III clinical trial, concluded today at the 27 de Noviembre polyclinic in the municipality of Marianao, Havana."

On the other hand, the Intervention Study, which is carried out in a controlled manner and without placebo, started last Monday also in Havana, with the participation of 150,000 subjects to evaluate the effects of vaccination in population sectors at high risk of infection, disease and spread of the pandemic.

This study will include 70,000 workers of the scientific pole and others belonging to the public health branch.

Precisely, the first volunteers were workers from the Molecular Immunology Center (CIM) and the IFV.

This evaluation is also intended to demonstrate the efficacy, effectiveness, and impact of the candidate on the individual to whom it is applied and to know if it protects anyone who is directly related to that person and has not been immunized.

The experts seek to prove the injectable results on the mortality caused by the coronavirus and to explore changes in the hospitalization rates in the reference population associated with the vaccination.

Cuba also has the anti-COVID-19 candidates Soberana 01 (from IFV), Abdala (also in phase III clinical trials), and Mambisa (the only one to be administered nasally), the last two developed by the Center for Genetic Engineering and Biotechnology (CIGB).