After concluding the rigorous evaluation process of the vaccine Soberana 02 and Soberana Plus, produced by the Finlay Vaccine Institute, CEDMED (Center for the State Control of Medicine, Equipment and Medical Devices) decided to grant the Emergency Use Authorization to these vaccines in accordance with the regulations and provisions in force, once t was demonstrated that both candidates comply with the requirements and parameters demanded in terms of quality, safety and efficacy.

This approval is based on the results obtained in Phase I, II and III clinical trials, as well as in the intervention study with groups and population at risk and the health intervention, which provided enough elements on the safety and efficacy of these vaccines, allowing their massive use in our country and their commercialization in other countries.

The combination of both immunogens of the Finlay Vaccine Institute demonstrated an efficacy of 92.1% in the prevention of the symptomatic disease, after the intermediate analysis of the results corresponding to Phase II clinical trials carried out with more than 40 000 volunteers in eight municipalities of Havana.

Dr. Vicente , General director of the Finlay Vaccine Institute, explained that in case of Soberana Plus-designed as a booster dose for the pre-existing immunity either by induced, natural or by other vaccines- the aims is to extend its use to the country’s convalescent population once the results of Phase II clinical trials concluded in the capital with 400 recovered patients.

The vaccination scheme combines two doses of Soberana 02 with a one dose of Soberana Plus and has been approved for the population over 19 years of age. These approvals are made effective through CEDMED Resolutions issued this Friday, which are available on the web page w.w.w.cedmed.cu.

After this Friday, CEDMED approved the Emergency Use Authorization of Soberana 02 dosage schedule plus a booster dose of Soberana Plus in the adult population. Cuba has three vaccines: Abdala, Soberana 02 and Soberana Plus.

Source: information provided by CEDMED and Gramma newspaper

Soberana 02 shows a 91.2% efficacy in its three-dose-scheme (+Video)

Abdala shows 92.28% efficacy in its thre-dose-scheme

Vaccine candidate Mambisa is included in the world nasal inmunogens list

Clinical trial with vaccine candidate for stimulating the immune response is approved in Cuba