- BBC World News
Some countries have focused their efforts on importing coronavirus vaccines. Others, like Cuba, are focused on producing their own vaccines.
According to the scientific organizations of that country, they are currently working on the development of at least four possible vaccines against covid-19 that 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 drugs in Cuba, said in the Roundtable program Eduardo Martínez.
The four vaccine candidates are in phases I and II of clinical trials, in which their efficacy and safety in humans.
One of them, called Soberanda 02, could enter 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 100 million doses of Soberana 02 in 2021, which, in addition to immunizing its more than 11 million inhabitants, could also export your 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 caution.
The Pan American Health Organization, for its part, has shown optimistic, but warns that the candidates must pass all 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.
Cuba works in parallel on four possible vaccines.
On the one hand they are Sovereign 01 and Sovereign 02, 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. Its action is based on the same type of antigen that is used in the area of the virus spike, which is the key with which the virus enters the cell.
So the idea is generate antibodies in that area to inhibit the entry of the virus into the cell, explained Martínez, from BioCubaFarma.
They also have in common the advantage that, according to their creators, they only require between 8 ° C and 2 ° C cooling.
The difference between them lies in each one has different formulations.
The two Sovereign vaccines use an antigen obtained from 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 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).
In the race of the four candidates, Soberana 02 seems to be leading.
It is a conjugate vaccine. That means that an antigen fuses with a carrier molecule to enhance its stability and efficacy.
In this case, what is done is to join a tetanus toxin to the protein that the virus attaches 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 the protein carries, thereby crashes its entrance to 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 one third dose of Soberana 01 as reinforcement.
Sovereign 02 technology has already been used successfully in other vaccines manufactured in Cuba.
“They are using a safe technology“, tells BBC Mundo Andrés Vecino, a doctor specializing in health systems at Johns Hopkins University, in the US, who is not involved in these investigations.
So far, according to Cuban researchers, Soberana 02 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 the 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 42,600 participants on the island.
In January, the Finlay Institute announced that it had reached an agreement with Iran to transfer the technology of Soberana 02 and carry out phase III trials in that country.
Both nations face harsh penalties 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 is a way of being self-sufficient in the production and supply of vaccines.
In addition, Cuba and Mexico They are in talks about the possibility that the latter also carry out phase III trials of Soberana 02, according to 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 his first million shots.
If all goes well, Cuba aspires to vaccinate your entire population before the end of 2021.
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 journals scientific peer reviewed, a standard to verify the validity of a study.
“There’s no particular reason to think things wouldn’t work out,” Vecino says, but “we have to wait for the studies to come out and they publish them. “
A similar view is held by 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 reviewAccording to Vecino, it is the same that was done 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 went well“says Neighbor.
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 Soberana 02 vaccine, but did not receive an immediate response.
What the WHO says
“Soy optimistic The results are going well, “said José Moya, PAHO / WHO representative in Cuba in January.
The Sovereign 02 vaccine appears within the WHO vaccine development monitoring.
At a press conference on February 17, the assistant director of the Pan American Health Organization, Jarbas Barbosa, said that they are aware that phase 2 is being concluded in Cuba.
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 provide information to this organization and thus opt for funds that delivers for vaccine development.
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 type of international assistance.
Covid-19 in Cuba
Until February 17, Cuba had reported 40,765 cases of covid-19 and 277 deaths.
This figure, although it is low compared to other countries in the region such as Mexico or Brazil, is sufficient to exercise pressure on health system Cuban, according to Grant reports.
By mid-2020, Cuba had managed to contain the outbreak thanks to a combination of a aggressive campaign of mitigation and at the closure of 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, they have begun to report more than 1,000 cases a day.
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Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.