The Center for Genetic Engineering and Biotechnology (CIGB) presented the required documentation to the regulatory authority for Drugs, Equipment and Medical Devices (CECMED) on October 31st for its third vaccine against COVID-19.
According to the national TV news, the second technical meeting took place where the representatives of the CIGB presented the documentation. If it is approved, the CIGB can begin Phases I, II and III clinical trials of the COVID vaccine.
Clinical trials of Soberana I, the first Cuban vaccine against COVID-19, have had satisfactory results, without adverse or serious reactions. However, it is still necessary to determine the level of antibodies that the vaccine generates in volunteers.
Once the specialists have evaluated the new vaccination compound, a meeting will be held to discuss the results.
Each lot of vaccine manufactured or imported has to pass the evaluation process. Once it is ready, its use is authorized by means of a certificate.