Abdala and Soberana 02: Cuba achieves the first Latin American vaccine with effectiveness data at the level of Pfizer and Moderna | Society

Two nuns leave a vaccination room this Wednesday in Havana (Cuba) after being immunized with the national vaccine against covid-19, Abdala.
Two nuns leave a vaccination room this Wednesday in Havana (Cuba) after being immunized with the national vaccine against covid-19, Abdala.Ramon Espinosa / AP

Cuba is one step away from achieving the first Latin American vaccine against covid-19, with efficacy levels similar to those developed by Pfizer or Moderna and higher than those of AstraZeneca or Sputnik V. This is clear from the first results obtained from the third testing phase of Abdala and Soberana 02, two of the candidates produced by the Center for Genetic Engineering and Biotechnology (CIGB) and the Finlay Vaccine Institute (IFV), respectively. The CIGB reported that Abdala has shown an effectiveness of 92.28% after applying three doses to a group of more than 48,000 volunteers, while the protection of Soberana 02 is 62%, with two injections, but the results are still expected. results of the third puncture, which should increase its effectiveness, indicated the IFV.

“This is excellent news and fills us with optimism in the region, where there is still a large deficit of vaccines,” said the representative on the island of the Pan American Health Organization (PAHO), José Moya, who has followed closely the development of Cuban formulas. The Peruvian epidemiologist affirmed that in the coming days the Cuban regulatory authority, the Center for the State Control of Medicines, Medical Equipment and Devices (CECMED), must approve its emergency use, with which Abdala and later Soberana 02 may be applied in the large-scale island, something that has already started as an “intervention study in higher-risk populations and territories” parallel to phase 3 trials. As of June 19, 2,244,336 people had received at least one dose of one of the vaccine candidates in Cuba, representing 19.9% ​​of the population.

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The purpose of the health authorities is to have 70% of the island’s inhabitants vaccinated in September, and 100% before the end of the year. When the data from the trials are published and the dossier is prepared, Cuba may request WHO prequalification and validation of its vaccines, a procedure that requires rigorous reviews, scientific checks and exchanges, which can take months. “It is a very meticulous process carried out by the WHO with those candidates who have concluded phase 3 trials and have efficacy results and have been authorized by the National Regulatory Authority. If all goes well, before the end of the year Cuban vaccines will be able to join the eight already prequalified in the world ”, explained Moya.

Cuba is currently working on five vaccine candidates against covid-19, all with patriotic names: Soberana 01, Soberana 02 and Soberana Plus, which are developed by the IFV; and Abdala and Mambisa (the latter has the peculiarity of being administered by nasal spray), created by the CIGB. All Cuban prototypes are protein subunit vaccines, which are based on inoculating a protein from the coronavirus spike, the part that binds to the cells it infects, to produce an immune response. The difference is that in all three of the IFV the antigen is made in mammalian cells, while the CIGB develops the protein fraction of the coronavirus in yeast.

A nurse injects the Abdala vaccine at the Cuban National Center for Medical Genetics, in Havana.
A nurse injects the Abdala vaccine at the Cuban National Center for Medical Genetics, in Havana.Hector Garrido

Cuba has more than 30 years of experience in producing vaccines, to the point that 80% of those used in its national vaccination scheme have been developed on the island. Some, such as hepatitis B or meningococcal hepatitis, have been widely used in Latin America and other countries in the world with the support of the WHO. According to Moya, the “solidity” of the regulatory authority is a guarantee that Cuban vaccines against covid-19 will be of good quality, since CECMED has been working with PAHO for years and is considered one of the eight reference centers and highest level in the region.

With the approval of CECMED, surely in a week, Cuba could begin to design a vaccine export plan, even before the WHO gives it the go-ahead. “Countries have autonomy to make bilateral agreements. If there is a country interested in acquiring Cuban vaccines, PAHO and WHO do not participate because those are direct agreements, ”says Moya, who has been working on the island for two years and knows well the work of Cuban scientists. “At WHO there is a follow-up, and once the vaccines are approved in Cuba, the other step is to publish the data in scientific journals and request prequalification. If the WHO approves it, Cuban vaccines could be part of those distributed by the Covax mechanism or by the PAHO Revolving Fund ”.

Moya affirms that this is not only “excellent news for Cuba, but it is also a reason for hope for the region, where vaccines are lacking and the problem will not be solved until late next year. He thinks that Cuban vaccines can be very useful in Latin America, and affirms that PAHO Director Carissa Etienne has urged countries that have the capacity to produce vaccines, such as Mexico, Argentina, Brazil and Cuba, “to work together , coordinate efforts, make technology transfer, putting solidarity and Pan-Americanism first ”.

Paradoxically, this Cuban scientific achievement occurs in the midst of a very serious economic crisis, when the country lacks all kinds of supplies, including the most basic medicines, such as antibiotics. This can only be explained, according to the epidemiologist, by the scientific level reached and the existence of a wide network of research centers that, although they have few resources, keep their know-how intact. The island has bet everything on its own vaccines, for this reason it did not participate in the WHO Covax mechanism nor did it acquire them on the international market. Cuba is currently experiencing the third and worst outbreak of the coronavirus epidemic, with record numbers of infected in two consecutive days (1,880 cases and 16 deaths on Wednesday, and 2,055 cases and 13 deaths on Tuesday), for a cumulative 174,789 cases and more than 1,600 deaths since the pandemic began.

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