Havana, April 13 (ACN) The five Cuban COVID-19 candidate vaccines have proven to be safe from the scientific, methodological and ethical perpectives, while an ethic committee endorses the quality of research and guarantees the protection of the rights and wellbeing of the volunteers involved in current vaccination trials.
The head of the Commercialization and Regulatory Issues with the National Clinical Trial Coordination Center, Julian Rodriguez said that over 150 commissions are in charge of reviewing and evaluating clinical protocols before their approval and the involvement of the any volunteer to join trials.
When the clinical trial opened with the vaccine Soberana 01 in August, a main committee was set up and later a second committee join in when phase II trials began for Soberana 02 which involved 910 volunteers.
Since phase III increased in the number of volunteers to 44010, the committee was further expanded to include 18 scientists from different institutes.
Similar actions were taken with the trials for the Abdala candidate vaccine which used 48 thousand volunteers in the eastern part of the country.
The National Ethic and Research Commission was set up in 2004 to standardize this kind of work in the country said the specialist, because ethic committees were already operative when the first biotech centers were created in the 1980s.
The working teams with the National Ethic Commission for Research are made up of workers from the Center for the State Control of Drugs and Medical Equipment (CECMED), by presidents of Ethic committees and experts all under the Science and Technological Innovation Department of the Cuban Health Ministry.
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