Step of Soberana 02 production.
Havana, March 1 (RHC)-- The Provincial Defense Council of Havana discussed Sunday technical and organizational details of the Phase III clinical trial of the Soberana 02 Cuban-designed anti-Covid-19 vaccine.
The trial is set for this month.
Reportedly, 44 010 people, aged between 19 and 80 years, from eight municipalities of the Cuban capital, will be included in the trial to demonstrate the vaccine candidate's effectiveness for preventing the disease caused by SARS-COV-2.
"Once the protocol is approved by Cecmed and published in the public registry of clinical trials, more details will be provided, but it is important to work on the operationalization of the trial due to the complexity it represents in logistical terms," said Dr. Dagmar Garcia, director of Research at the Finlay Vaccine Institute, in her Facebook profile.
This study and those that will continue as part of the clinical development of Soberana 02 are designed under the ethical and regulatory rigor required for the development of these vaccine candidates, approved by an Ethics Committee and by CECMED, published in the registry of clinical trials before their start and supervised by an Independent Data Monitoring Committee.
Much progress has been made in just ten months of developing these vaccine candidates, but neither rigor nor ethics in research have been sacrificed. "Every day is another step forward, but we are sure that we are making steady progress," said the researcher.
Since February 1, with the Saturnino Lora hospital, in Santiago de Cuba, as the setting, phase II of the clinical trial of the Abdala vaccine candidate (CIGB 66) against COVID-19 is underway.