The development of the Cuban biotechnological system occupies a prosperous place worldwide. Among the characteristic features that promote its success, publications of the World Health Organization highlight that in biotechnology on the island the government is the main investor, that the national market is the highest priority and that among the research-development- production there is synergism instead of individual skills. Dr. Gerardo Guillén Nieto, director of Biomedical Research at the Center for Genetic Engineering and Biotechnology (CIGB), speaks about these issues.
—How has the CIGB been able to produce the Mambisa and Abdala vaccines in such a short time? Because, although this success counts the experience and prestige gained by the institution, it is an extraordinary achievement.
-Yes. Without a doubt. We are very proud of having obtained these vaccines, and of having been able to contribute to combating the epidemic in our country. But it is not fortuitous, it is the result of the development of biotechnology in Cuba, the development of science, which is a strategy that the government outlined from the very beginning of the Revolution. We have our own human resources; that is to say, all the workers of the Center for Genetic Engineering and Biotechnology (CIGB), of all the biotechnology institutions and of the national pharmaceutical industry, are Cubans trained by the country, and who have reached their scientific and technological level working in our institutions and universities. That is the main strength that we have, and it comes from the very development of the educational and human resource training strategy outlined by the Revolution, and from the prioritization of science. So we already had this when the anticovid vaccines had to be made.
“We also had an industry that had more than thirty years of experience in the development of biotechnological products and vaccines, with inter-institutional integration, another of the bases that Fidel traced when he created biotechnology, the biological front, the Scientific Pole. Integration, not competition, which is the most characteristic in other systems. The development of these vaccines is the result of a great cooperation between different institutions, of many technologists and researchers”.
In this regard, Dr. Guillén Nieto cites the participation of the Immunoassay Center, with contributions such as antibody response evaluation systems; from the Center for Molecular Immunology, which not only contributed to obtaining and producing the antigen used in the Sovereign vaccine, but have also contributed to the development of biological reagents necessary for analytical methods for evaluating vaccines; of the National Civil Defense Laboratory, which has high-security laboratories where it was possible to work with the virus and where the methodology for evaluating the neutralization response of the sera of the volunteers in the clinical studies was established.
“The neutralization response?”
-Yes. It is the ability of the antibodies in the serum of the vaccinated or convalescent to neutralize the virus, to prevent it from penetrating the cells. This test must be done in high-security facilities —because the virus is being worked on— such as those of the National Civil Defense Laboratory, which assumed all the development of the vaccines. For these functions, a smaller capacity was also recently opened at the Pedro Kourí Institute of Tropical Medicine (IPK).
“In other words, there has been an important contribution from many research centers, from all the hospitals of the Ministry of Public Health in carrying out the clinical studies. Our health system has been able to immunize the entire population in a short period of time, to promote high levels of immunization and high percentages of people vaccinated. Without those coverages, vaccination would not have had the same impact.”
It means that the success is due to the integration between all these centers, the hospital network, the Ministry of Public Health, social structures that already existed before and that have been strengthened even during the fight against Covid.
In this sense, the expert also underlines that in Cuba we do not have anti-vaccine movements. “In the United States and Europe, there is a high percentage of the population that has not wanted to be vaccinated.” In Cuba, the population demands to be vaccinated, they are concerned if the vaccine takes a little longer to reach a province or health area; people volunteer to participate in clinical studies, which have required large numbers of them. In Phase III of Abdala there were forty-eight thousand volunteers; These are considerable figures.
“And, despite the blockade, which affects us enormously, all this has contributed to the fact that in such a short period of time the vaccines have been obtained and that our population is vaccinated. The political will of our state, of the Ministry of Public Health, of the leaders of the country and of the provinces, who have facilitated the clinical studies, the logistics, the support that is needed to be able to set up the vaccinations, to guarantee the transportation, refrigeration, the cold chain”.
—Within the group of anticovid vaccines that have emerged in the world with different technologies, what place do you give to Cuban vaccines? We know that there is always a lot of propaganda against our vaccines and in favor of others. Are those better?
—Vaccines are difficult to compare because they would have to be evaluated in the same clinical study, at the same time and in the same population, since there are many factors that can influence the response to vaccines; among them, the circulation of viruses, of their different variants, the previous immune response that the population may or may not have due to greater or lesser contact with the viruses in circulation. Therefore, one cannot compare vaccines evaluated in separate studies. I think the main thing is to have vaccines and be vaccinated with the one that is available.
“But there are vaccines that have shown more than 90% efficacy. Cuban women are included in that group, and they have been evaluated in very rigorous studies.”
The Phase III study of Abdala, with forty-eight thousand volunteers —Guillen Nieto explains—, was double-blind, randomized and placebo-controlled. “Half of them received the vaccine and the other half, the control group, was not given the fundamental component, the antigen, the protective protein, but a placebo. This is the maximum rigor in clinical studies.”
He comments, that placebo-controlled means that the study is random, random. “There is no way to bias the population that acquires one or another component. And double-blind means that the researchers, the medical staff, do not know who was given the vaccine and who was given the placebo. Therefore, as everything is codified, there can be no influence, intervention of the researchers in the result, and neither do the volunteers know it. All of these, equally, were followed up for symptoms and confirmation by PCR.
“Efficacy is calculated taking into account the volunteers who have had symptoms. In the Abdala group there were one hundred and twelve volunteers who were symptomatic, confirmed by positive PCR in the placebo group, and only eleven in the vaccinated group. This is what gives an efficiency of 92.28 percent.
“These are very rigorous studies that give rise to such efficacy, which above ninety percent places Abdala in the group of vaccines that have a high level of efficacy. Then there are other vaccines that have about seventy, seventy-eight percent, others more than sixty, and they are equally good vaccines, but with a lower level of efficacy.
“So, really, the Cuban vaccines are very good and they have demonstrated it in practice, which is what is known as effectiveness, their use in the open population. And more recently it is shocking that while in the world the Omicron wave has had a higher incidence of cases than the Delta wave, which was the previous one, in Cuba it has been much lower with the Omicron viral variant than with Delta, because it found a population ninety percent immunized, including all children over two years of age, a vaccination in which Cuba was also a pioneer.
“Both vaccines, Soberana and Abdala, are authorized for use in children over two years of age. In the country, Soberana has been used mainly in children; Abdala has been used in the pediatric population, mainly in Nicaragua and Vietnam. There are more than four million children who have been immunized with the Abdala vaccine; in Cuba, with Soberana, around 1.7 million children.
“On the other hand, the long duration of the immune response with both Cuban vaccines has been demonstrated, when 90 percent of the population is already immunized just at a moment very close to the entry of the Omicron variant . Also, those who had been vaccinated first were already receiving the booster.
“The high incidence with the Delta variant in the country occurred much later than its peaks in other nations. And a fundamental contribution in its control was also made by vaccines and the management of the epidemic in general, together with all the aforementioned factors.
—You have spoken of the efficiency and effectiveness of Abdala. When will they know about Mambisa?
—We are already in the final stage of evaluating samples from the clinical study of Mambisa as a booster in volunteers who received the first vaccination with Abdala. Although we still have about 150 to include in the age group over sixty years in the convalescent reinforcement study. We hope that this process can be concluded soon and that, at the latest, by the middle of this year we will be presenting all the documentation to the regulatory authority.
— One last question Dr. Guillén, why has the World Health Organization (WHO) not included our vaccines in its registries yet? Does it have to do with the unjustified criticism that certain groups make against Cuban vaccines?
-Do not. Everything that surrounds questions, unfounded propaganda against our vaccines has nothing to do with the WHO. That is one more invented argument for this permanent battle, fundamentally sponsored by the US government, by the counterrevolutionary elements, a pretext to create problems and then criticize the country for them and prevent any economic, social development.
“Actually, the WHO is not the one that approves the use of a vaccine, it is the national regulatory authorities. In fact, Cuban vaccines are already approved in several countries without yet being qualified by the World Health Organization.
“The qualification by the WHO logically gives credibility, gives visibility, gives quality support to the vaccines, but it is not decisive. Although it is for the movement of people internationally, since many countries have established as a requirement – it is a national decision in each case – that the vaccines qualified by the WHO are those that are accepted for entry or free movement. So this has affected us. We do not share that position because the important thing is the immune status of the person, not what vaccine was given, if it definitely has high levels of antibodies.
What is decisive is the immune status of the person and that can be achieved with any vaccine. But hey, we don’t make the rules. We have many cases of Cubans who have traveled and in the laboratories of other countries they are impressed with the high titers of antibodies they have because they are immunized with our vaccines. There are even provinces, such as Ontario, in Canada, that accept Abdala, without it being approved by the WHO.
“In the list of European vaccines, to be considered in the vaccination card, Abdala is also included. Although they do not accept it for free movement, they do recognize it as a vaccine. In many Latin American countries, such as Mexico, it is authorized.”
With Abdala —concluded Guillén Nieto— we have already started the process of submitting to the WHO, but it takes time because it involves the examination of many documents, of the entire development of the vaccine, of the production system, of the clinical results and of effectiveness. This also entails intense exchanges of questions and answers in both directions. These are stages that must be completed so that the vaccine can qualify. (Taken from Cuba en Resumen).
Top image: Application of the Mambisa vaccine candidate with a Cuban nasal prototype. Clinical trial in convalescents from Covid-19. Hermanos Ameijeiras Hospital, Havana, July 30, 2021. Photo: Ariel Ley Royero/ACN.
Source: Flor de Paz. Union of Cuban Journalists. Available at https://www.cubaperiodistas.cu/index.php/2022/03/cuba-pureza-y-eficacia-de-mambisa-la-primera-vacuna-nasal-anticovid-ii-parte/