The Mast, 22 August 2020. CUBA is scheduled to start clinical trials of Soberana 01, a possible vaccine against COVID-19 on Monday next week. With 11 million inhabitants, the Caribbean island has managed to contain the coronavirus pandemic with 3,408 cases, 88 deaths and 2,794 cured as of Monday, this week.
A recent outbreak forced the authorities to reinforce prevention measures in Havana. The Centre for State Control of Medicines, Equipment and Medical Devices (Cecmed) has approved the submission of a prophylactic drug against the SARS-CoV-2 coronavirus, developed by the Finlay Institute of Vaccines, for Phase I / II studies.
According to the Cuban Public Registry of Clinical Trials website, the process would begin on August 24 and end on January 11, 2021. The research to develop the immunising drug covers 676 people between the ages of 19 and 80 and would be carried out in a “randomised, controlled, adaptive and multicentre way with the aim of evaluating the safety, reactogenicity and immunogenicity of the candidate in a two-dose scheme.”
According to the publication, the results of the trial would be available on February 1 and published on February 15 next year. This week, Cuban President Miguel Díaz-Canel noted the progress of the project and showed confidence in the response of national science to prevent the spread of the coronavirus.
The Cuban leader stressed the importance of having a drug of their own against COVID-19, even if other nations had their own, as a matter of sovereignty. On May 19 this year, President Díaz-Canel said, “although there are vaccines from other countries, we need ours to have sovereignty.” And according to Cuban health authorities, clinical trials in humans from the island’s COVID-19 vaccine project, the ‘Sovereign 01’, whose results are scheduled for February 2021 start next week.
The recruitment of candidates starts on August 24 and ends month end of October.According to Cuban health authorities, the people the vaccine would be tried on should not present “clinically significant alterations” and must give written consent to receive the dose. On Saturday last week, Russian authorities reported progress in the production of their Sputnik V vaccine. They even expressed their intention to produce it with Cuba. But the socialist island did not officially pronounce on the offer.
The chief of epidemiology of Cuba, Francisco Durán, said he expected the country to have access to a vaccine only during the first quarter of 2021. Western researchers were skeptical of the Russian product and were making progress on various projects. In Latin America, Argentina and Mexico recently announced an agreement to produce a vaccine designed by AztraZeneca with University of Oxford. The Cuban government tends to show off the development of its biotechnology and boasts among, their achievements, own vaccine against Hepatitis-B.