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The emergence of Soberana 1 is not a chance event

Cuba vacunaSince the beginning of the Revolution, the priority granted to scientific progress, with emphasis on the training of highly qualified human capital and the creation of research centers in dissimilar branches of knowledge, were essential prerequisites that allowed Cuba to venture into the promising sector of biotechnology in the decade of the 1980s, practically at the same time this industry was emerging in a small group of nations with greater technological development.

Today, with Cuba emerging as the first country in Latin America and the Caribbean to conduct clinical trials of a COVID-19 candidate vaccine, many inside and beyond the country’s borders are wondering how this was possible, in such an adverse economic scenario, aggravated by the tightening of the economic, commercial and financial blockade imposed by the United States government.

On the subject, Granma spoke to Doctor of Science Eduardo Martínez Díaz, president of the BioCubaFarma enterprise group, who outlined the principal results achieved by our scientists in the field of vaccine production over the last 30 years, to explain how Soberana 1 was developed.

“Cuba has significant experience in the development and production of vaccines. Today, the national biopharmaceutical industry manufactures eight of the eleven products included in the expanded immunization program.”

This, he pointed out, has allowed for vaccination coverage in the country of more than 98%, with a significant impact on the elimination of several infectious diseases and reduction of the incidence rate of others.

As Dr. Martínez points out, the BC meningitis vaccine, developed by the Finlay Institute under the leadership of Dr. Concepción Campa Huergo, in the late 1980s, was the first of its kind in the world to control type B meningitis.

Patented by Cuban scientists, the vaccine received the Gold Medal from the World Intellectual Property Organization (WIPO). Its use throughout the country, since the 1990s, has allowed for a significant reduction in the incidence of the disease, which is now considered under control.

“Another important contribution is undoubtedly the recombinant hepatitis B vaccine, which was developed by scientists at the Center for Genetic Engineering and Biotechnology (CIGB) under the direction of Dr. Luis Herrera Martínez.

In addition to noticeably reducing the presence of the disease in Cuba, no cases of children under the age of five infected with the hepatitis B virus have been reported since 2000.

“Currently, the entire population, up to 40 years of age, is immunized against the disease, which causes approximately a million deaths annually worldwide. It was the first vaccine in Latin America and the Caribbean to achieve certification by the World Health Organization (WHO), and we could become one of the first countries to eradicate the disease.”

Among Cuban milestones in the field, Dr. Martinez also mentioned the vaccine against haemophilus influenzae type B, originally developed at the University of Havana, based on investigations conducted by Dr. Vicente Vérez Bencomo, along with researchers from several biotechnology institutions.

“Its novelty lies in being the first such vaccine to be used in humans, including an antigen obtained via chemical synthesis, and was granted WHO certification, a necessary requirement to supply United Nations agencies.”

No less significant is the development of our pentavalent vaccine against diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type B, the second to be achieved worldwide and the first produced by a Latin American and Caribbean country,” he said.

“Our vaccines have international prestige, made evident by the fact that hundreds of millions of doses manufactured on the island have been supplied to more than 40 nations.”

All the experience accumulated by our institutions provided the basis for Cuba to act quickly and produce a first COVID-19 candidate vaccine, now undergoing clinical evaluation in humans, along with other potential vaccines in the advanced phase of preclinical studies, Dr. Martinez stated.

-How was the work organized at BioCubaFarma to launch this important vaccine project?

- As soon as the epidemic emerged in China, we quickly began thinking about a vaccine. In fact, we presented a development proposal at the Chinese-Cuban Research and Development Center that we have in Yonzhov, Hunang province, in China.

The project is characterized as a search for a universal vaccine that is effective against the coronavirus, not only SARS-COV-2. After being approved, it was funded for execution in China.

After the disease became a pandemic, we immediately activated the scientific advisory committees at the Finlay Vaccine Institute and the Center for Genetic Engineering and Biotechnology, institutions with significant experience in vaccine issues.

Likewise, we created a working group which included BioCubaFarma institutions as core participants, among them, the Center of Molecular Immunology (CIM), the National Center of Biopreparations (BioCen), the Immunoassay Center (CIE) and the National Center for the Production of Laboratory Animals (Cenpalab). All would contribute their grain of salt to the task, which has had special support from the Ministry of Public Health, including the Center for State Control of Drugs, Equipment and Medical Devices (Cecmed).

The strategy was to design multiple variants based on our own technological platforms. We have worked intensely and, logically, some variants were discarded along the way, and others are showing very good results.

One of these is Soberana 1, currently in clinical trials. Before the end of 2020, it is very likely that we will have at least another two candidate vaccines being evaluated in humans

As the candidates use different technological platforms, which do not compete in terms of production capacity, this will allow us to rapidly produce the necessary quantities to immunize our entire population and also the vaccine available to countries that need it.

Developing different variants of vaccines also serves the purpose of administering them in different ages, that is, a vaccine for children could be different from one we use in adults and, among adults, we will be able to differentiate for those over 60 years of age, who we know require a more potent vaccine to achieve the necessary levels of immunity for protection against the virus.

The challenge, launched by President Miguel Diaz-Canel, to achieve sovereignty with a vaccine of our own and produce it rapidly, mobilized our scientists and technologists. We have worked hard, in unity, with intelligence, and we are going to do our duty, which means fulfilling our duty to the people, to Fidel and Raul.

Soberana 1 is currently undergoing clinical trials and it is possible that before the end of 2020, Cuba will have at least two other candidate vaccines being evaluated in humans.

(Taken from Granma)

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