The Center 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. The process will begin on August 24th and end on January 11, 2021, according to the Cuban Public Registry of Clinical Trials website. Cuba should conclude clinical trials of "Soberana 01" - a vaccine candidate against COVID-19 - by early next year.
The research to develop the immunizing drug covers 676 people between the ages of 19 and 80 and will be carried out in a "randomized, controlled, adaptive and multicenter 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 will be available on February 1st and will be published on February 15th.
Yesterday, Cuban President Miguel Díaz-Canel noted the progress of the Cuban project and showed confidence in the response of national science to prevent the spread of the new coronavirus. Earlier, the Cuban leader stressed the importance of having a drug of their own against COVID-19, even if other nations have their own, as a matter of sovereignty. (RHC). Cuba will start the next week trials clynics in humans from their covid-19 vaccine project, the “Sovereign 01”, whose results are scheduled for February 2021, health authorities reported Tuesday.
He Cuban Public Registry of Clinical Trials and the Center for State Control of Medicines, Equipment and Medical Devices, gave the green light to begin trials on 676 people between 19 and 80 years old. The recruitment of candidates will begin this August 24 and will end at the end of October. Those people should not present “clinically significant alterations” and must give written consent to receive the dose, authorities said.
It is planned that the study concludes on January 11 and that the results are ready on February 1, 2021 and published on the 15th of that month. Although there are vaccines from other countries, we need ours to have sovereignty, “President Miguel Díaz-Canel said on May 19. On Saturday, 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 in this regard that 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 are making progress on various projects. In Latin America, Argentina and Mexico recently announced an agreement to produce the designed by AztraZeneca and the University of Oxford. The Cuban government tends to show off the development of its biotechnology, and show among their achievements own vaccine against Hepatitis-B.
With 11 million inhabitants, the island has managed to contain the new coronavirus pandemic, with 3,408 cases, 88 of them deceased and 2,794 cured at the end of Monday. A recent outbreak forced the authorities to reinforce prevention measures in Havana.