Final steps for Soberana 02, the first Latin American vaccine against coronavirus

Pagina 12 (Spanish) | Wednesday, 24 February 2021 | Click here for original article

"In the second half of the year, we will be able to immunise the entire population, and also provide doses to the countries that require it," says director of Science and Innovation at Cuban state company BioCubaFarma, Rolando Pérez Rodríguez, interviewed here by Pagina 12.

A few days after starting the last phase of the clinical trial of Soberana 02, which has all the cards to be the first fully developed vaccine in Latin America, the Cuban scientific community confirmed that it expects a production of 100 million doses for this year.

"It is about sharing with the world what we are, the answer that Cuba can give to the problem of the pandemic," reflected Rolando Pérez Rodríguez.

"We will be able to vaccinate the entire population before the end of the year but we will also have production capacity to offer it to other countries that demand it," said the specialist. At the end of March, another of the Cuban vaccines, Abdala, developed by the Center for Genetic Engineering and Biotechnology (CIGB), joins the third phase of clinical trials.

BioCubaFarma, founded in 2012, is a state company that brings together 32 companies from the biotechnology sector and the Cuban pharmaceutical industry. With 20 thousand workers, it exports more than 300 products to 50 countries, and has to its credit about 700 medical records. Since the coronavirus began to spread around the world, its resources have been focused on managing the pandemic.

On the one hand, the development of vaccines -four of them in an advanced stage-, and on the other, the production of drugs to address infections and efforts to increase diagnostic capacity, which resulted in the achievement of one of the the lowest fatality rates in the world - with only 300 deaths in total until this Monday - despite the increase in infections in recent weeks, which have seen cases in Cuba rise from 12 to 45 thousand.

Why develop your own vaccine?
“Various reasons converge. In Cuba, one of the strengths of the biotechnology industry is precisely the development of vaccines. Furthermore, from the moment in which potential agreements began to be made in the rest of the world, at very high prices, to acquire vaccines that did not yet exist, we realised that they were not going to reach it.

For us, the economic blockade of the United States, especially in this last period -during the government of Donald Trump-, complicates our access to certain products and we cannot always reach the most suitable supplier, this added to the fact that we are experiencing a global shortage of certain supplies, such as syringes. Despite this difficulty, we made progress. The idea of the vaccine is to be able to show that just as Cuba needs the rest of the world, it can also contribute a lot.

“So far, of the dozens of investigations to develop an antigen against the coronavirus, four Cuban vaccines are on track. Two are in charge of the Finlay Vaccine Institute (IFV), Sovereign 02, with 150 thousand doses ready for the start of the third phase of clinical trials, and Sovereign 01, still in the first stage of human trials. The other two are in charge of the CIGB: the Mambisa, a novelty due to its nasal administration characteristics, and the Abdala, which begins the last stage of large-scale trials in humans at the end of March.

“The four vaccine candidates use the RBD protein as antigen, which binds the viral body with the human cell. For both Abdala and Sovereign 02, the specialists foresee the application of three doses, with an immunization schedule of 0-28-56 days, although for the first they still evaluate a shorter schedule, of 0-14-28 days.”

-Tell us about Sovereign 02?
“The most important thing is that it is a secure platform. It has not shown any adverse effects so far. It is a conjugated subunit vaccine, based on the RBD protein, which is a domain -subunit- of protein S, by the term “spike” (Spike), in English. RBD, binding to the receptor, allows the virus to penetrate the human cell. The vaccine inhibits this binding, generating neutralizing antibodies. We chose this type of vaccine based on recombinant proteins because we have experience with the same technology in previous research, against other viruses, and the capacities not only to investigate, but to take production to an industrial scale.”

-When will it begin to be mass produced?
“First we have to go through phase 3, which, as there is more incidence of the virus in the country, although this is bad news for society, facilitates the clinical study. For this stage we manufacture 150 thousand doses. In parallel, we are going to increase the evidence of effectiveness with trials in areas that we know have more epidemiological complexity due to population density. And in the meantime we are advancing in protection, immunising thousands of people. For the month of June, the results will be in, for the registration and massive use of the vaccine, and in the second part of the year we will be able to immunise the entire population, and also provide doses to the countries that require it. The productive capacity we have for this type of vaccine is really great, which uses only a fifth of an antibody.

“For this phase of the clinical trial, the IFV - under the orbit of BioCubaFarma - signed an agreement with the Pasteur Institute of Iran, to send a dose contingent of Sovereign 02 as part of the vaccine trials. Iran is one of the Middle Eastern countries most affected by the coronavirus. The vaccination campaign with the Russian Sputnik V vaccine began earlier this month.”

Cuba has a long tradition in biotechnology: it was the first country to eradicate polio, developed the first vaccine against meningitis, in the late 1980s, and managed to produce its own vaccine against Hepatitis B in 1990. What was it? the key to vaccine development?

“Experience in other investigations allowed us to move forward with some speed, but it was also the product of coordination between the companies and the Scientific Pole, we always work in an integrated way, in a productive chain that strengthens and accelerates projects. In the case of the two vaccines that are on the horizon -Soberana 02 and Abdala- those in charge of large-scale production are the National Center for Biopreparations (Biocen) and the Aica Laboratory, but always in coordination with the other institutions that were part of the investigation.”

-In addition to the four vaccines that are in an advanced stage, are there others in progress?

“Yes, we are in favour of not stopping the investigations. There are already new strains of the virus that may be resistant to vaccines, if we continue to investigate, we can prevent the problem. There are other developments that we continue to work on at the preclinical level, vaccines that could be recombined to combat the most resistant strains.

We are also beginning the second phase of the trials of Sovereign 02 in the paediatric population, which in Cuba is considered from preschool to 19 years of age, but now we must concentrate on the most urgent thing, which is to advance rapidly with production in order to begin mass vaccination.”

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