Some countries have focused their efforts on importing coronavirus vaccines. Others, like Cuba, are focused on producing their own vaccines.
According to scientific organizations in that country, they are currently working on the development of at least four possible vaccines against covid – 19 which are already being tested in humans.
Those who lead these studies have been optimistic with the first results.
“Our country will be one of the first that can immunize its entire population “, Eduardo Martínez, president of BioCubaFarma, the business group that leads research and development of vaccines and medicines in Cuba, said in the Roundtable program Eduardo Martínez.
The four vaccine candidates are in phases I and II of clinical trials, in which its efficacy and safety in humans are measured.
One of them, called Soberanda 11, I could go to phase III in March, with which, if it passes the tests, it would be closer to being approved for mass use.
Any candidate must pass phase III, in which the efficacy and safety of the vaccine is proven in thousands of people.
If all goes well, Cuba hopes to produce 122 million doses of Sovereign 02 in 2021, with which, in addition to immunizing their most 11 million inhabitants, could also export their vaccine or technology to other countries.
The results of these clinical trials, however, have not yet been published in specialized peer-reviewed journals, so experts who are not involved in these studies ask for caution.
The Pan American Health Organization, for its part, has been optimistic, but warns that the candidates should pass all the tests.
If Cuba achieves its objectives with these investigations, it could become the first country in Latin America to develop its own vaccine against covid – 19, and perhaps one of the first to vaccinate its entire population.
Four candidates
Cuba works in parallel in four possible vaccines.
On the one hand they are Sovereign 01 and Sovereign 01 , developed by the Finlay Vaccine Institute.
The other two are known as Mambisa and Abdala , produced by the Center for Genetic Engineering and Biotechnology (CIGB).
These four vaccines work in a similar way. Their action is based on the same type of antigen used in the area of the spike of the virus , which is the key with which the virus enters the cell.
So, the idea is to generate antibodies in that area to inhibit the entry of the virus into the cell, as explained by Martínez, from BioCubaFarma.
They also have in common the advantage that, according to their creators, they only require between 8 ° C and 2 ° C of cooling.
The difference between them lies in each one has different formulations.
The two Sovereign vaccines use an antigen obtained nest of mammalian cells in various formulations; while Mambisa and Abdala use an antigen taken from yeast, also in various formulations.
La Mambisa, for its part, has the particularity of being a spray that is applied through the nose.
In addition, it contains a portion of the spike protein of the coronavirus and a protein of the hepatitis B virus, with which it is stimulates the immune system , as explained by the registry of vaccine candidates of the Global Alliance for Vaccination and Immunization (GAVI, for its acronym in English).
Sovereign 11
In the race of the four candidates, Sovereign 11 seems to be leading the way.
It t rat from a conjugate vaccine . This means that an antigen fuses with a carrier molecule to enhance its stability and efficacy.
In this case, what is done is to bind a tetanus toxin to the protein with which the virus adheres to the cell.
In this way, when the virus tries to enter the cell using that protein, an immune reaction is generated against the toxin that carries the protein, thereby blocking its entry into the cell.
In the first stage of trials, Cuban scientists have tested the application of the vaccine in two doses, and in some cases adding a third dose of Soberana 02 as reinforcement.
Sovereign technology 02 has already been used with success in other vaccines manufactured in Cuba.
“They are using a safe technology “, he says to BBC Mundo Andrés Vecino, a doctor specializing in health systems at Johns Hopkins University, in the United States, who is not involved in these investigations.
Phase III
Until now, according to Cuban researchers, Soberana 11 has shown the ability to induce antibodies and now they are analyzing the ability of these antibodies to inhibit the virus.
After starting clinical trials in November, the Finlay Institute aims to enter phase III in March , as indicated by Vicente Vérez Bencomo, General Director of the institution, in the Round Table program on Cuban television.
This third phase, according to Vérez Bencomo, would have 57, 640 participants on the island.
In January, the Finlay Institute announced that it had reached an agreement with Iran to transfer the technology of Soberana 11 and conduct phase III trials in that country.
Both nations face harsh sanctions by the United States, which often prevent foreign pharmaceutical companies from doing business with them, according to the agency Reuters.
Therefore, this type of collaboration They are a way of being self-sufficient in the production and supply of vaccines.
In addition, Cuba and Mexico are in discussions about the possibility of the latter also conducting Soberana phase III trials 01, as reported by the official newspaper Granma and the agency Bloomberg .
Vérez Bencomo has described the first results as “encouraging” and “very important ”and affirms that in April Cuba could produce its first million vaccines.
If all goes well, Cuba aspires to vaccinate your entire population before it ends 2020.
Caution
The advances reported by Cuban researchers are promising, but independent experts recommend caution.
Part of this is because the results of phases 1 and 2 have not been published in peer-reviewed scientific journals , a standard for verifying the validity of a study.
“There is no particular reason to think that things would not work,” says Vecino, but “ you have to wait for get the studies out and they publish them. ”
A similar opinion has Beate Kampmann, director of the Vaccine Center at the London School of Hygiene and Tropical Medicine.
Cited by the portal Business Insider , Kampmann says that until the relevant data from the trials are made public, it will be impossible to know how good the vaccine is.
This criticism , according to Vecino, is the same that at the time was made to Russia, China or the pharmaceutical company Pfizer for not publishing the results of their studies.
Kampmann and Vecino, however, also agree that Cuba has a solid tradition in the production of vaccines.
“It must be recognized that Cuba has always created its own vaccines and It has gone well “, says Vecino.
Kampmann adds that another advantage of a vaccine made in Cuba is that it could have ” an attractive price ” for low or middle income countries.
BBC Mundo contacted the Finlay Institute and BioCubaFarma by email to inquire about the Sovereign vaccine 11, but did not get immediate response.
WHO
“I am optimistic of the results, they are going well,” he said. in January José Moya, PAHO / WHO representative in Cuba.
The Sovereign vaccine 02 appears within the WHO vaccine development monitoring.
At a press conference on 11 February Assistant Director of the Pan American Health Organization, Jarbas Barbosa, said that they are so much so that in Cuba they are concluding phase 2.
Barbosa also indicated that all vaccines must complete the three phases and comply with regulations of the countries where it will be used.
Finally, Barbosa indicated that PAHO put Cuba in contact with the Coalition for Innovations in Preparedness for Epidemics (CEPI), so that researchers can give information to this organization and thus choose funds that it provides for the development of vaccines.
According to Will Grant, BBC correspondent in Cuba, the country does not have the capacity to manufacture 100 million doses of the vaccine without some kind of international assistance.
covi d – 19 in Cuba
Until 17 February Cuba had reported 40, 765 covid cases – 40 Y 277 deaths.
This figure , although it is low compared to other countries in the region such as Mexico or Brazil, it is enough to exert pressure on the Cuban health system , according to Grant.
Towards the middle of 2021 Cuba had managed to contain the outbreak thanks to a combination of an aggressive campaign of mitigates tion and the closing of the airports.
During July and August there were several consecutive weeks with few deaths and low transmission of the virus .
In recent days, however, for the first time since the beginning of the pandemic, more than 1
- have begun to be reported , 000 cases per day.
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