By Ángel Guerra Cabrera on August 20, 2020
The Cuban Public Registry of Clinical Trials reported on August 18 that Cuba will begin the first stage of clinical trials for a COVID-19 vaccine in four days. Recruitment for the trial will take place between August 24 and October 31. This phase will culminate on January 11, 2021, and the results will be available on February 1 and for publication on February 15. Sovereign 01 is the name of the drug, of which two doses will be applied to a sample of 676 people between the ages of 19 and 80 without clinically significant alterations and who are giving their written informed consent to participate in the trial.
The project, led by the Finlay Vaccine Institute, was registered on August 13, when the Center for State Control of Medicines, Medical Equipment and Devices approved the vaccine to be a candidate for phase I and II clinical trials. On several occasions, President Miguel Díaz-Canel has met with the team of scientists developing it to verify the progress and has insisted on the need to have a Cuban vaccine against COVID-19 as a matter of sovereignty, despite the fact that other countries are also working towards the same goal.
In the first phase of the trial, it is expected that the vaccine will be safe to administer and that no more than 5 percent of individuals will have adverse side effects, while in the second phase, the proportion of subjects with an immune response is expected to be at least 50 percent higher than in the control group. The registration date of the vaccine has a great symbolic meaning because it is also the 94th birthday of Fidel Castro, the undisputed strategist and driving force, almost immediately after the triumph of the Revolution, in 1959, of Cuba’s emblematic health and biomedical research system.
In the same way, the constant and very intense dedication to obtain the vaccine against COVID-19 by a group of Cuban scientists reminds us of those to whom Fidel entrusted in 1981in the development and obtaining of the first interferon in the island; a mission that they fulfilled in little more than three months. Cuba also has three other vaccine candidates in development. In fact, of the new coronavirus patients treated on the island since April 14 with Heberón (the commercial name of the interferon-alpha 2b developed with Cuban technology), only 5.5 percent reached the stage of seriousness, and the lethality among them was 0.9 percent.
Cuba has a long tradition of administering, producing and developing prophylactic drugs, since the remarkable physician and hygienist Tomás Romay applied the anti-pox peptide to his children in 1796 to prove its effectiveness. The island p11 prophylactic vaccines and in recent decades has created the anti-hepatitis B, anti-meningococcal BC, Haemophilus Influenzae B vaccines and the promising therapeutic vaccines against lung (Cimavax) and pancreatic cancer. An average of 4.8 million doses of vaccine, single or combined, are administered annually in Cuba protecting people against 13 diseases produced in the country. Begun in 1962, Cuba’s immunization program has led to the elimination of six diseases, two serious clinical forms, and two serious complications that existed previously, with the remaining diseases maintaining incidence and mortality rates that are not a health problem.
Havana has confronted COVID-19 and diseases such as dengue hemorrhagic fever and hemorrhagic conjunctivitis basically through the application of drugs produced today by the Biocubafarma business complex, the heir and continuator of the complex of research centers created at the initiative of Fidel. Biocubafarma is working on 16 projects of new treatments and medical technologies to prevent and fight Covid-19. Of these, 11 are already in the phase of clinical studies or intervention trials on patients and groups at risk.
Biocubafarma has evaluated five products for preventive purposes in order to stimulate both innate and adaptive immunity in different people, including healthcare personnel. Among them, Biomodulin T has shown great effectiveness; applied to a group of elderly people, none had been infected with the coronavirus since the last time I asked.
The best proof of the effectiveness of bioscience products and the competent work of Cuban health personnel in confronting COVID-19 is in the data on the behavior of the disease on the island. Of the 3842 confirmed cases, 2863 have been recovered, 88 have died and 761 have been admitted, of which only seven are reported as serious and four as critical. All of this has taken place despite the harmful impact of the U.S. blockade, cruelly tightened by Donald Trump.
Source: La Pupila Insomne, translation Resumen Latinoamericano, North America bureau