Final stages for Soberana 02, the first l …

A few days after the start of the last phase of the clinical trial of Sovereign 02, which has all the chips to be the first vaccine fully developed in Latin America, the Cuban scientific community has confirmed that it foresees a production of 100 million doses for this year. “It is about sharing with the world who we are, the response that Cuba can give to the problem of the pandemic”, he declared. Rolando Pérez Rodríguez, Doctor of Biological Sciences and Director of Science and Company Innovation BioCubaFarma, in dialogue with Page 12. “We will be able to vaccinate the entire population before the end of the year but also we will have production capacity to offer it to other countries that they require it, “assured the specialist. At the end of March, he joined the third phase of testing clinical another of the Cuban vaccines, Abdala, developed by the Center for Genetic Engineering and Biotechnology (CIGB).

BioCubaFarma, founded in 2012, is a state-owned company that brings together 32 companies from the biotechnology sector and Cuban pharmaceutical industry. With 20,000 workers, it exports more than 300 products to 50 countries, and has around 700 medical records to its credit. Since the coronavirus began to spread around the world, its resources have been focused on pandemic management. On the one hand, the development of vaccines – four of them at an advanced stage – and, on the other hand, the production of drugs to fight infections and efforts to increase diagnostic capacity, which has resulted in the achievement of one of the lowest death rates. rate in the world – with only 300 deaths in total until Monday – despite the increase in infections in recent weeks, when of 12 thousand cases, Cuba had more than 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. Also, the moment potential deals started to be made in the rest of the world, at very high prices, to acquire vaccines that did not yet exist, we realized that they were not going to be there. reach. 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 on top of the fact that we are experiencing a global shortage of certain supplies, such as syringes. Despite this difficulty, we have made progress. The idea of ​​the vaccine is to be able to show that just like Cuba needs the rest of the world, it can also bring a lot.

So far, out of the dozens of investigations to develop an antigen against the coronavirus, four Cuban vaccines are on their way. Two are managed by the Finlay Vaccine Institute (IFV), the Sovereign 02, with 150,000 doses ready for the start of the third phase of clinical trials, and the Sovereign 01, still in the early stages of human testing. The other two are in charge of the CIGB: the Mambisa, novel for its nasal delivery characteristic, and the Abdala, which begins the last phase of large-scale human trials in late March.

All four vaccine candidates use the RBD protein as an antigen, which binds the viral body to the human cell. For Abdala and Sovereign 02, specialists plan the application of three doses, with a vaccination schedule of 0-28-56 days, although for the first, they still estimate a shorter schedule, of 0-14-28 days .

-How is Sovereign 02?

-The most important is that it is a secure platform. It has not shown any adverse effects so far. This is a conjugated subunit vaccine, based on the RBD protein, which is a -subunit- domain of the S protein, by the term “spike” (Spike), in English. RBD, binding to the receptor, allows the virus to enter 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 of the same technology in previous research, against other viruses, and the ability not only to investigate, but also bring production to industrial scale.

-When will it start to apply en masse?

-You must first go through phase 3, which, as there is more incidence of the virus in the country, although this is bad news for the company, facilitates the clinical study. For this step, we manufacture 150 thousand doses. At the same time, we will increase the evidence for efficacy with trials in areas that we know are more epidemiologically complex due to the density of the population. And meanwhile we are making progress in protection, vaccinating thousands of people. For the month of June The results will be for him record and the massive use of the vaccine, and Second part we will be able immunize the whole population, and also provide doses to countries that need them. The production capacity that we have for this type of vaccine is really large, which only uses a fifth of antibodies.

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

-Will Sovereign 02 arrive in Argentina?

-I don’t see why not. It is still premature to talk about distribution, because we have to see how the vaccine is registered and which countries accept the authorization of the local entity. There are many actors in the region, but no specific agreement has yet been reached.

Cuba has a long tradition in biotechnology: it was the first country to eradicate polio, it developed the first meningitis vaccine in the late 1980s, and it has successfully produced its own hepatitis B vaccine. in 1990. What is it? vaccine development?

-Experience in other research has allowed us to move forward with a certain speed, but it was also the result of coordination between companies and the Scientific Pole, we always work in an integrated manner, in a production chain that enhances and accelerates projects. In the case of the two vaccines looming on the horizon -Soberana 02 and Abdala- those responsible for large-scale production are the National Biopreparations Center (Biocen) and the Aica Laboratory, but always in coordination with the other institutions which were part of the investigation.

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

-Yes, we are not to stop the investigations. There are already new strains of the virus that may be resistant to vaccines, if we keep investigating, we can avoid the problem. There are other developments that we continue to work on at the preclinical level, vaccines that could be recombined to fight against the most resistant strains. We are also starting the second phase of the Sovereign 02 trials in the pediatric population, which in Cuba is considered from kindergarten to the age of 19, but now we must focus on the most urgent thing, which is to quickly move to production in order to start mass vaccination.

Report: Lorena Bermejo