Abdala became the first Cuban vaccine candidate approved by the country's regulatory authority for emergency use on Friday, which makes Cuba the only country that until now has its own vaccine in Latin America.
The announcement of the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) indicates that this decision took place after concluding a rigorous process of evaluation of the file presented to the institution and having carried out the pertinent inspections of the plants involved in the productive process.
After confirming that the established requirements are met and based on the data obtained in the completed Phase I and Phase II Clinical Trials and a Phase III Clinical Trial in progress, the authorization was issued.
Abdala, developed by scientists from the Center for Genetic Engineering and Biotechnology (CIGB), has shown an efficacy in the prevention of symptomatic forms of the disease of 92.28%, as well as an adequate safety profile, supported by the number of doses applied in the clinical trials carried out; the intervention study in risk populations and the health intervention carried out in the country.
The day before the director of the Finlay Institute of Vaccines, Vicente Vérez, reported that the vaccine candidate Soberana 02 reached an efficacy of 91.2 percent, after applying the third booster dose Soberana PLUS.
In addition to Abdala and Soberana 02, Cuba has three other projects of this type in different research phases: Mambisa from the CIGB, as well as Soberana 1 and Soberana Plus, from the Finlay Vaccine Institute.
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