Cuba: Vaccine Candidate Abdala Ends Phase III Clinical Trials

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A total of 48,290 inhabitants of Bayamo, Santiago de Cuba, and Guantánamo participated in the research. More than 97 percent of them received the three doses of the pharmaceutical product, a figure that illustrates widespread adherence to the immunization protocol.

Francisco Hernández, head of the clinical study, explained to the Cuban News Agency that at this stage, all volunteers would be followed up to detect symptomatic positive cases with SARS-CoV-2 virus infection, which causes the systemic disease.

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This procedure, he said, will make it possible to determine the proportions of the test subjects who became ill according to the group: placebo or vaccinated with CIGB-66 (Abdala), and constitutes an effective way to measure the primary variable of the phase.

He said that obtaining efficacy results will depend on the delay in the appearance of volunteers infected with the coronavirus as estimated in the research design, a total of 150. However, they foresee intermediate cuts for every 50 infected volunteers.

The expert referred to the role of the Joaquín Castillo Duany military hospital in the city because, in a centralized way, it will assume the attention of all those confirmed with COVID-19 from Granma, Guantánamo, and Santiago de Cuba included in the clinical trial.

Hernández said that in the last six weeks, since March 22, the system for the adequate reception of these people was strengthened in various healthcare institutions and the Veguitas isolation centers and Mariana Grajales vocational school for positive cases, contacts, and suspects to the illness.

He insisted on the importance of reinforcing protection measures against the virus in a very complex epidemiological scenario due to high transmission, mortality, and the circulation of new strains and variants of SARS-CoV-2.

He also urged the participants in the Abdala study to maintain individual care because some received the vaccine and others placebos; hence not all are protected.

He stressed that vaccines may not prevent coronavirus infection, but are intended to prevent the development of severe and severe forms of the disease and, consequently, deaths from COVID-19.

The head of the clinical study highlighted the feat that constituted the injection of the vaccine candidate, completed on Saturday, May 1st, in thousands of people in phase III. It ratified the commitment of all the specialists with the successful completion of the Abdala clinical study.

Along with this formulation, Cuba has Soberana 02, from the Finlay Vaccine Institute (IFV), also in the third stage of trial in volunteers in the capital, with a more extended vaccination schedule of 0-28-56 days.

In addition, Cuban scientists have developed the anti-COVID-19 vaccine candidates Mambisa from the CIGB and administered nasally, and Soberana 01 and Soberana Plus, the latter in phase II trials for 450 convalescents.

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