They are called Soberana 02 and Abdala, and they are the two Cuban vaccine candidates against covid-19 that have gone the furthest in their development. Both are in phase 3 — the last before approval — of clinical trials. If everything goes as Cuban scientists hope, before the end of the summer, the island could have its own vaccine with which to immunize its entire population, 11.2 million inhabitants. If approved by the National Regulatory Agency of Cuba, something that seems very likely, in the coming months Soberana 02 and Abdala will become the first anti-covid vaccines conceived and produced in Latin America.
The Pan American Health Organization (PAHO) considers it a luxury and a ‘privilege’ that a small country like Cuba has managed to develop five vaccine candidates, and that two are in the last stage of clinical trials testing its effectiveness. “It is not a miracle: there is remarkable scientific development in Cuba and 30 years of experience in manufacturing vaccines,” said José Moya, PAHO / WHO representative in Cuba, in a recent interview with the Spanish newspaper EL PAÍS. He said that it is no coincidence that the island was the first country to develop a meningococcal vaccine, in addition to manufacturing — in the early 1990s — another against Hepatitis B that was widely used in Latin America and Africa.
“It is not a miracle: there is remarkable scientific development in Cuba and 30 years of experience in manufacturing vaccines,” said José Moya, PAHO / WHO representative in Cuba.
All Cuban prototypes are based on inoculating a protein from the coronavirus spike, the part that binds to the cells it infects, to produce an immune response. Soberana 02, where expectations are highest, also adds an immune response enhancer. Cuba has already successfully developed another vaccine using this principle against the Haemophilus influenzae b bacteria responsible for some meningitis and pneumonia.
According to Moya, Cuban scientists are working on known platforms. “These types of vaccines are the most traditional and safest, in addition to having the advantage that they are kept at a temperature of two to eight degrees,” said the Peruvian epidemiologist, who considers it a strength of Cuba to have a solid and reference regulatory agency in Latin America, such as the Center for State Control of Medicines, Equipment and Medical Devices, with which PAHO has collaborated for years. It is this agency that will finally decide whether Soberana 02 and Abdala become vaccines and authorizes their emergency use before all tests are concluded.
Volunteer trials
On April 3, the application of the first dose of Abdala was completed on 48,000 volunteers from the eastern provinces of Santiago de Cuba, Guantánamo and Granma, and on April 5, the second injection of this vaccine began to be administered — they will be three doses (0, 14 and 28 days apart) in two groups, one experimental and the other a control group. On April 5, the application of the second dose of Soberana 02 was also started with approximately 42,000 volunteers included in the Phase III trial in Havana.
Soberana 02 was the island’s first anti covid-19 candidate to reach the last stage of trials, but with a longer schedule of injections: at 0, 28 and 56 days.
From the laboratories of BioCubaFarma, an entity to which 32 institutes, research centers and industries of biotechnology and pharmaceutical production belong, more than 300,000 doses of Soberana 02 and Abdala have already been produced, and their directors assure that they have the capacity to produce 100 million vials before the end of 2021.
The stated goal is to have at least one vaccine ready by the summer and to start mass vaccination in July and August. Cuban authorities intend to have half the population immunized in September and all Cubans before the end of the year.
“The results so far are encouraging: both vaccine candidates have been shown to be safe and capable of generating specific antibodies against the virus. We are optimistic,” said, shortly before phase III began, Eulogio Pimentel, vice president of the BioCubaFarma business group, which produces eight of the 13 vaccines that are part of the island’s national vaccination program.
The five Cuban candidates against covid-19 — all with patriotic names — are: Soberana 01, Soberana 02 and Soberana Plus (conceived for those convalescing from Covid-19, and currently in phase 2 of clinical trials), which are developed by the Finlay Institute; and Abdala and Mambisa (which has the peculiarity of being administered by nasal spray), from the Center for Genetic Engineering and Biotechnology.
For Cuba, successfully crowning the development of its vaccines is of crucial importance. First of all, for the scientific and political prestige it represents, but also for economic reasons at a time when the island is going through one of the worst crises in its history, and when the coronavirus epidemic is at its worst (an average of 1,000 daily cases in recent days), and there are no plans to purchase any foreign vaccines.
Cuba intends to export its vaccine, and some countries in the area have already expressed their interest. Venezuela announced last week that it is preparing to manufacture the Abdala vaccine, still in the testing phase, in a laboratory in Caracas, in cooperation with the Government of Havana. Jamaica and Suriname, among other countries of the Caricom (Caribbean Community), have also shown interest in accessing Cuban vaccines when they are ready.
[Translation to English by Progreso Weekly.]
