Technicians work in the fermentation area of one of the production plants of the Center for Genetic Engineering and Biotechnology of Havana.Héctor Garrido
In the coming days, Cuba will place two vaccines against covid-19 developed in its laboratories in the final phase of clinical trials.
Their names are Soberana 02 and Abdala, and from March their effectiveness will be tested in tens of thousands of volunteers from Havana, Santiago de Cuba and Guantánamo, although Mexico and Iran could also participate in phase III of the Soberana 02 trial. Cuba It is the first country in Latin America to go so far in developing its own vaccine, a scientific achievement that brings it closer to the goal of immunizing its entire population before the end of the year, although it contrasts with the crisis situation and acute shortage that the island is experiencing.
“The results so far are encouraging: both vaccine candidates have been shown to be safe and capable of generating specific antibodies against the virus, inhibiting the binding of the viral protein to the cellular receptor (the virus's entry gate into the cell), and neutralizing the infection. of the virus in susceptible human cell cultures.
We are optimistic, so far the candidates have exceeded the goals that these stages require internationally, ”Eulogio Pimentel, vice president of the Cuban business group BioCubaFarma, which brings together 32 institutes, research centers, and biotechnology and pharmaceutical production industries, told El PAÍS.
We are at the Center for Genetic Engineering and Biotechnology (CIGB), and Pimentel takes out paper and pencil: he says that last week the world reached a peak in vaccinations, 6,160,000 doses administered in a single day.
"But at that rate," he says, "it will take three years and five months to vaccinate the world's population."
Cuba's bet is another: to develop its own vaccine project and produce 100 million doses before the end of the year, which would allow it to meet its internal needs (vaccinate 11.2 million Cubans) and export the rest.
“If all goes well in this third phase of clinical trials [the last one before the approval of a vaccine], in a few months we will be able to begin mass vaccination and conclude before the end of 2021. We would be one of the first countries in the world to achieve the immunization of its entire population, ”says Pimentel.
It confirms that a first batch of 150,000 doses of Sovereign 02 has already been successfully produced and works in a second.
Similarly, Abdala (named after the patriotic poem of the Cuban National Hero, José Martí) entered the large-scale production phase, to begin clinical trials in the coming weeks.
"At the moment Cuba is working on four vaccine candidates, which is a luxury in the region," says Peruvian José Moya, representative in Cuba of the Pan American Health Organization (PAHO / WHO).
"This is not a miracle: there is a remarkable scientific development in Cuba and 30 years of experience in manufacturing vaccines," he points out, noting that the island was the first country to develop a meningococcal vaccine, in addition to manufacturing - at the beginning of the ninety- one against Hepatitis B that was widely used in Latin America and Africa.
The four Cuban candidates against COVID-19 - all with patriotic names - are: Soberana 01 and Soberana 02, developed by the Finlay Institute;
and Abdala and Mambisa, who are from the CIGB, a center that Pimentel directed for five years.
The scientist explains that all four are based on the protein subunit vaccine approach, which use a viral protein or part of it (in this case the RBD, the SARS-CoV-2 protein S region) to induce a protective response specific in the vaccinated person.
"This type of genetically engineered vaccines are the most traditional and safest, as well as having the advantage that they are kept at a temperature of 2 to 8 degrees," says Moya.
Sovereign 02, the most advanced
So far, the most advanced is Soberana 02, a conjugate vaccine that combines the RBD protein of the virus with tetanus toxoid, enhancing the immune response.
Cuba has already successfully developed another vaccine with this principle against haemophilus influenzae type b, responsible for diseases such as meningitis, pneumonia and epiglottitis.
"We work on known platforms and that is security," says Pimentel.
The results of Soberana 02 in Phase I and II have been good, say the Cuban scientists, who have already made public some reports of their research.
Efficacy will now be tested in a group of 42,000 people in Havana and another 50,000 in Iran, under an agreement reached with the Pasteur Institute in that country.
Mexico is also negotiating to participate in the trial, as confirmed by Foreign Minister Marcelo Ebrard.
Abdala's effectiveness will be measured in a group of tens of thousands of volunteers in Santiago de Cuba and Guantánamo, provinces that together with Havana have registered the highest number of positive cases of coronavirus in recent weeks.
Sobrana 02 will initially require the administration of two doses, and Abdala will evaluate whether two or three doses are appropriate according to the efficacy results shown in the phase III study.
Although it is in an earlier phase of clinical development, Mambisa is another of the important bets of the CIGB, having the peculiarity that its administration is intranasally, instead of the usual intramuscular route, which would greatly facilitate the logistics of vaccination.
“Having several projects is good and allows us to work with more options.
We are doing everything without relaxing the demand and requirements of good clinical, development and productive practices, under the supervision of CECMED, our regulatory authority ”, affirms the vice president of BioCubaFarma, a giant in which 20,000 people work and produces 60% of the medicines and 80% of the vaccines used on the island.
Although the declared goal of producing 100 million doses in 2021 may seem crazy, given the serious economic crisis that the island is going through, the scientist says it is not.
There is the "know-how" of Cuban science, he says, and "production plants designed with the capacity to produce ten times more than what the country needs."
He does not hide that the challenge is great, when medicines of any kind and basic necessities are scarce in the street - GDP fell by 11% in 2020 due to the pandemic.
The resources dedicated to research have also fallen, but the evils are replaced by the existence of a true "integrated scientific system", assures the director of the Center for Neurosciences of Cuba, Mitchell Valdés.
"We are talking about more than thirty scientific institutions that cooperate closely with each other and are not competing, and that work perfectly coordinated with the health system," he says.
"That Cuba in such a short time and in the midst of this crisis is about to release a vaccine, is a reflection of the maturity reached by Cuban biotechnology in recent decades," says Valdés, explaining that, in addition, Cuban scientists are they have become true experts in extending the life of medical equipment and in finding "imaginative" solutions to the problems derived from the North American embargo, which prevents access to numerous supplies.
As we tour the Fermentation Area of one of the CIGB production plants, an engineer approaches Pimentel and they talk about the accusations of Bioterrorism that the United States made against Cuba years ago.
"A group of American scientists came here, and in five minutes they ruled it out," he recalls.
Again Pimentel takes out a pencil and paper: "Of the more than 2,000 million dollars in international aid that has been allocated to research to find a vaccine against covid-19, Cuba has not touched anything."
He is cautious, but says he is proud of what he has achieved.
"Of the 66 vaccine candidates in the clinical phase that are being developed in the world, 20 are based on the protein subunit vaccine approach: four are ours," he says.
