This week Cuba became the first country in Latin America and the Caribbean, and, probably, the first among all poor countries to have a vaccine against COVID-19 in Phase III clinical trials – Soberana 02. This has unmistakable humanistic and geopolitical connotations which we will discuss below; these are accentuated by the tensions of the international situation.
On Monday, March 8, administration of the first doses of vaccine and placebo began for 44,010 volunteers in eight districts of Havana. A second dose will be given 28 days later and in some cases, the third dose of vaccine will be added with another Cuban vaccine in trials, Soberana 01A or Soberana Plus. This third dose trial seeks to achieve a higher level of immunity, including immunity against the new variants of the coronavirus.
But this is not all the news in the rapid advance of Cuban vaccines, since probably in this same month of March, as soon as it is authorized by the national regulatory agency, the Phase III trial of Abdala, another Cuban vaccine, will begin in Santiago de Cuba and Guantanamo with 42,000 persons. Together with those already mentioned and Soberana 01 and Mambisa, these constitute the line-up of the five vaccines under investigation in Cuba.
The goal of the Phase III trials is to prove that the vaccine has the ability to prevent people from getting sick, fundamentally that it is capable of preventing illness from advancing to serious and potentially lethal stages. Ideally, the vaccine would prevent people who have been vaccinated from becoming infected with the virus at all, even as an asymptomatic infection, but at this point, that is a desirable goal but still a hypothesis, which will have to be tested in its turn. Both the safety and the immunogenicity of the vaccine are now being verified.
With regard to safety, prior phases of trials have demonstrated a high degree of safety for all the Cuban vaccines, with the side effects most cited by trial participants being one or two days of mild soreness at the injection site, and not even a single report of any reaction requiring hospitalization. Cuban experts also confirm that a high degree of immunity is produced, although I have not been able to find the exact statistics. In selecting participants in the trials, the requirements are that one must be a volunteer, and give informed consent; there are other qualifications such as being between 19 and 80 years old, and, in the case of women, an agreement to avoid pregnancy during the duration of the study. Factors that are exclusionary include having had an acute infectious disease in the seven days prior to the vaccination or having been infected with COVID-19. To carry out these measures and provide follow-up by expert personnel to each participant, from the time of the vaccine to the finalization of the study and the conclusions drawn from it, requires highly skilled medical and nursing personnel, and a high degree of organization. Tremendous surprise and admiration is elicited by the fact that Cuba is able to achieve scientific developments that are so complex in the setting of the extremely cruel and strangling economic and financial blockade imposed by the United States, with methods calculated to cut off the possibility of Cuba’s obtaining financing or access to essential equipment, supplies, and raw materials, such as fuel and pharmaceuticals. Many of these measures were imposed during the pandemic with the clear intention of worsening the economic shortages caused by the strict standards of infection prevention or the very costly actions required to combat the coronavirus.
While 10 countries monopolize about 80% of the vaccine supply and 80 countries have no access to any vaccine at all, Cuba is already producing 100 million vaccine doses, which will allow Cuba to not only immunize their whole population this year, but also to share the vaccine with the ALBA (Bolivarian Alliance for the Peoples of Our America) countries and also Iran, Vietnam, and many other countries that are requesting it. From those who can afford it, Cuba may obtain an economic return to re-invest in Cuban science and the pharmaceutical industry, but it is certain that the distribution of the Cuban vaccine will give access to COVID-19 immunity to countries and populations where there was little likelihood that this could have been obtained in any other way. The vaccine shortage is such that what is urgently needed are more vaccines ready for trials, more transfer of technology, an increase in production, reduction of prices, credit for financing, and, in many cases, donations from rich countries to poor countries. In short, we must abandon the absurd concept that any country can save itself from the pandemic alone. Accessible vaccines for all countries, especially the poorest countries, are an absolutely essential step, as the President of Mexico, Andrés Manuel Lopez Obrador has insisted.
Source: La Pupila Insomne,