Abdala Shows 92.28% Efficacy in its Single Three-dose Scheme
The First Secretary of the Central Committee of the Communist Party of Cuba and President of the Republic of Cuba, Miguel Díaz-Canel Bermúdez, learned that the efficacy of Abdala is 92.28%, which exceeds the requirements of the World Health Organization (WHO) for a vaccine candidate against COVID-19 to become a vaccine, which is 50%.
Upon hearing the news, the President said: "I think of Martí, who wrote: "it is not the intelligence received and casual what gives man honor; but the way he uses it and saves it, there is only one way to last and that is to serve".
With this result, the request for Emergency Use Authorization will soon be made to the Center for State Control of Medicines, Equipment and Medical Devices (CECMED) and, once approved, Abdala will become the second vaccine against COVID-19 developed in Latin America and the Caribbean, highlighted the BioCubafarma group on its Facebook page.
This vaccine candidate, designed by CIGB, is composed of the active pharmaceutical ingredient, which is the RBD (receptor binding domain), which is added to the formulation with aluminum hydroxide and other components.
On December 7, the Phase I clinical study began with 132 subjects between 19 and 54 years of age. Safety and immunogenicity were studied there.
In Phase II (660 volunteers) it was extended to 80 years of age, once the safety data of the vaccine candidate had been demonstrated.
In Phase III (48,290 volunteers), in addition to safety and immunogenicity, efficacy was also studied.
The President of the Republic decided to meet with the scientists after being informed of the final efficacy analysis of Abdala. Photo: Revolution Studies.
From Saturday afternoon to Monday afternoon, 48 hours have passed in which Cuba, a poor and small country, has shaken the world, as pointed out by the First Secretary of the Communist Party of Cuba, Miguel Díaz-Canel Bermúdez, in a meeting with the researchers of the Center for Genetic Engineering and Biotechnology (CIGB).
The President of the Republic decided to meet with the scientists after being informed of Abdala's final efficacy analysis at Monday's meeting of the Government's Temporary Working Group for the Prevention and Control of COVID-19.
He also did so on Saturday, when he went to greet the researchers of the Finlay Vaccine Institute after learning that the Soberana 02 vaccine candidate, with its two doses, has an efficacy of 62 percent, a result that still does not contain the application of the third booster dose of Soberana Plus, which should also place it among the most effective vaccines to control the SARS-CoV-2 virus.
Abdala's efficacy places it among the vaccines with the best results in the world, those that have been produced in the main laboratories of the most developed countries with financing of hundreds of millions and billions of dollars, something that for Cuba is a chimera, even more so in the midst of the tightening of the economic, commercial and financial blockade so far during the pandemic.
Marta Ayala Avila, Ph.D., director general of the CIGB, explained that efficacy is the most important result of a vaccine. "It is its effect in real life," she said.
In presenting the achievement, she highlighted the work of the teams of scientists who worked on the Phase I/II and III clinical trials in Santiago de Cuba, Bayamo, Guantanamo and Havana, and thanked the 48,000 volunteers who were part of the research.
The final analysis of the efficacy studies of Abdala against symptomatic COVID-19, which were conducted by an independent group led by the Institute of Cybernetics, Mathematics and Physics, include not only the response to an initial strain of SARS-CoV-2 (DG614G), but also the Alpha, Beta and Gamma mutants, explained the director general of the CIGB.
The scientist recalled that the clinical trial included a placebo group and a vaccinated group, with three applications over a period of 0-14-28 days. She argued that the studies continue, that new evaluations and conclusions will continue to be made.
Dr. C. Marta Ayala also highlighted the work carried out by the Immunoassay Center, the AICA Laboratories and other scientific centers, as well as the Public Health workers, who have undertaken a fast and high quality vaccination process that is difficult to achieve in other countries around the world.
He pointed out that the group of researchers dedicates the result and thanks Commander in Chief Fidel Castro Ruz, founder of the CIGB, Army General Raúl Castro Ruz, the First Secretary of the Party, Miguel Díaz-Canel Bermúdez, and the pioneer scientists of this center.
Congratulations on behalf of Cuba
The President of the Republic decided to meet with the scientists after being informed of Abdala's final efficacy analysis. Photo: Estudios Revolución.
Listening to these results, commented the First Secretary of the Party, "one feels proud to be Cuban and to have compatriots like you".
We are, he said, under the emotion of the scientific results that you have achieved and of the feat that this country has done, which in less than 48 hours has given two consecutive news that are scientific milestones of a small island. A small island that has been blocked, which has been shot to death, but we are alive, among other things, because of these results.
I see this result, he added, "under the feeling of admiration we feel for you and of gratitude, because with these things our people are being saved, and with these things we are contributing to make real that conviction that Cuba saves lives in the midst of this pandemic".
The results are really impressive, he reiterated. In those results, he said, there is much to be said, and he recalled the early days of the pandemic, when "I was convinced that poor countries were not going to be able to have in a short time the available vaccines that the rich world was producing to prioritize the rich.
"That is why I asked our scientists, with the conviction, with the certainty that we could do it, that it was necessary to have Cuban vaccines to be sovereign in this situation as well".
We, he added, are one of the few who, having the vaccines to solve Cuba's problems, are thinking about how, with those same vaccines, we can solve the problems of millions in the world, and above all of the millions who have less and live today in a tremendous uncertainty caused by the disease.
You gave an answer in thirteen months, he reiterated, in a country that in the midst of the pandemic has been more blocked. The financial persecution has intensified, you have done everything possible so that not a drop of fuel arrives, you have done everything possible so that medicines do not arrive.
In the midst of this, and without the millions of dollars needed for such a project, we have these results. And this "has only been saved by your heart, which is worth millions, and the millions of reasons you have been defending, because you have been thinking about the millions of Cubans and the millions in the world who can benefit from it".
Here -the First Secretary of the Party later reflected- there is a fact of enormous loyalty and fidelity to Fidel's founding thought in relation to the development of biotechnology, then to Raúl's idea of improvement, going from a budgeted scheme to an entrepreneurial scheme; and it also has to do with a tribute to the founders, such as Dr. Luis Herrera and others who are here today, to the generations that have been passing through, and where all of them have been growing with these results.
This 92.28 percent efficiency rate -the President reiterated with emotion- puts us at an avant-garde, advanced level.
"Fidel, with that tremendous confidence he had, one day said that this was a great center that was going to have great scientific results. And this is a great scientific result, with which you have demonstrated the greatness of this center and the fidelity to that thought."
"On behalf of Cuba, congratulations," Díaz-Canel finally said to the CIGB researchers who have worked on the creation of Abdala, which is already an anti-COVID-19 vaccine.
The President of the Republic decided to meet with the scientists after being informed of Abdala's final efficacy analysis. Photo: Revolution Studies.
Source: Cubadebate and Presidency of Cuba