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Sovereign 02: What Is Known About The Vaccine That Cuba Is Developing Against The Coronavirus

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According to scientific organizations in 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 to be able to immunize its entire population president of BioCubaFarma, the business group that leads research and development of vaccines and drugs in Cuba, said in the Roundtable program. The four vaccine candidates are in phases I and II of clinical trials, in which their efficacy and safety in humans are measured . One of them, called Soberanda 02, could enter phase III in March, thus, 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 are proven in thousands of people. If all goes well, Cuba hopes to produce 100 million doses of Sovereign 02 in 2021, with which, in addition to immunizing its more than 11 million inhabitants, it could also export its 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 must pass all the tests.

If Cuba achieves its goals 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 candidatesCuba works in parallel on four possible vaccines. On the one hand, there are Soberana 01 and Soberana 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 similarly. 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.

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So, the idea is to generate antibodies in that area to inhibit the entry of the virus into the cell, according to Martínez, from BioCubaFarma.hey also have in common the advantage that, according to their creators, they only require between 8 ° C and 2 ° C of refrigeration. the difference between them is that 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.

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La Mamba, for its part, has the particularity of being a spray that is applied through the nose. Also, it contains a portion of the spike protein of the coronavirus and a protein of the hepatitis B virus, with which the immune system is stimulated, according to the registry of vaccine candidates of the Global Alliance for Vaccination and Immunization ( GAVI, for its acronym in English).Sovereign 02. 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 bind a tetanus toxin to the protein with which the virus attaches itself to the cell. Thus, when the virus tries to enter the cell using that protein, an immune reaction is generated against the toxin carried by 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 some cases adding a third dose of Soberana 01 as a booster. Soberana 02 technology has already been used successfully in other vaccines manufactured in Cuba. They are using safe technology,” Andrés Vecino, a doctor specializing in health systems at Johns Hopkins University, in the US, who is not involved in these investigations, tells BBC Mundo.

Phase III
So far, according to Cuban researchers, Soberana 02 has shown the ability to induce antibodies and now they are analyzing the ability that these antibodies have to inhibit the virus. After beginning 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, on the Round Table program on Cuban television. This third phase, according to Vérez Bencomo, would have 42,600 participants on the island.

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In January, the Finlay Institute announced that it had reached an agreement with Iran to transfer Soberana 02 technology and conduct phase III trials in that country. Both nations face tough sanctions from the United States, which often prevent foreign pharmaceutical companies from negotiating with them, according to Reuters. For this reason, this type of collaboration is a way of being self-sufficient in the production and supply of vaccines. Also, Cuba and Mexico are in talks about the possibility that the latter may also carry out phase III trials of Soberana 02, according to the official newspaper Granma and the Bloomberg agency. Verez Bencomo has described the first results as “encouraging” and “very important and affirms that in April Cuba could produce its first million vaccines.

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Cuba aspires to vaccinate its entire population before the end of 2021.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 reason, in particular, to think that things would not work, says Vecino, but “you have to wait until the studies 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 Business Insider portal, 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 strong tradition in vaccine production. It must be recognized that Cuba has always created its own vaccines and they have done well says Vecino.Kampmann adds that another advantage of a vaccine made in Cuba is that it could be attractively priced for low- and middle-income countries. contacted the Finlay Institute and BioCubaFarma by email to inquire about the Soberana 02 vaccine, but did not receive an immediate response.

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What The WHO

I am optimistic about the results, they are going well,” José Moya, PAHO / WHO representative in Cuba, said in January. The Sovereign 02 vaccine appears within the WHO vaccine development monitoring. In 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 the regulations of the countries where they 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 body and thus opt for funds it provides for the development of vaccines. According to Will Grant, a correspondent for the BBC in Cuba, the country does not have the capacity to manufacture 100 million doses of the vaccine without some form of international assistance.

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Covid-19 in Cuba As of 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 enough to put pressure on the Cuban health system, according to Grant. By mid-2020 Cuba had managed to contain the outbreak thanks to a combination of an aggressive campaign mitigates ing and closing 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 1,000 cases have begun to be reported a day.

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