“The Cuban Soberana vaccine is not due to a miracle but the consequence of political decisions”

From November 15 to 25, 35 Italian volunteers participated in a clinical trial on the Soberana vaccine in Havana, Cuba. Thanks to its public and high quality biotechnological research and health care system, the Caribbean island is the only low-income country worldwide to have made its own COVID-19 vaccines

December 20, 2021 by Maurizio Coppola
Giuliano Granato, national spokesperson of Potere al Popolo, was one of the Italian volunteers participating in the clinical trial SoberanaPlusTurin. Picture: Maurizio Coppola.

“Do you know the difference between our Soberana vaccine and Pfizer?” With this question, Dr. Vicente Vérez Bencomo, general director of the Cuban Finlay Institute for Vaccines, welcomed the Italian delegation for the clinical trial called SoberanaPlusTurin in La Pradera, the international health center inaugurated in Havana in November 1996.

SoberanaPlusTurin is the name of the observational clinical trial with 35 volunteers from Italy previously vaccinated in Europe who received a single dose of the Cuban vaccine SoberanaPlus as a boost. The observational study of the SoberanaPlus vaccine authorized by the Cuban regulatory entity CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos) seeks to evaluate its reactogenicity and immunogenicity in adult subjects resident in Italy.

This clinical trial, the first of its kind on the Caribbean island, is the result of an important and deep international scientific collaboration in the context of the current COVID-19 pandemic, mainly between the Finlay Vaccine Institute of Cuba, the Amedeo Di Savoia Hospital of Turin, and the Italian Agency for Cultural and Economic Exchange with Cuba (AICEC).

A people’s vaccine

Dr. Vicente Vérez Bencomo’s answer was direct and clear: “Pfizer developed a commodity to sell to the governments and make big profits; the collateral effect was that the populations were partially protected from the virus. In Cuba, we developed a vaccine to protect our people and we are succeeding. If we will be able to earn some money from our work, obviously we will be happy to invest it in new public research.”

Even without a prevailing mandatory vaccination, by the end of November 2021, almost 10.2 million Cubans have received at least one dose of vaccine (practically 100% of the vaccine-eligible population). Of these, over 9.2 million have received the second dose and 8.7 million Cubans (78%) have received the third dose. 82.1% of the total Cuban population (9.18 million people) has even completed the entire vaccination schedule (two doses of Soberana02 and one dose of SoberanaPlus or three doses of Abdala).

This is not only a higher vaccination rate compared to other low-income countries around the world, where on an average, only 2.8 per cent of the population was vaccinated by the end of November. It is also a higher vaccination rate compared to developed countries in the global North. And Cuba has also already started its booster vaccination program. By the end of November, over 311,000 people had received a fourth vaccination. As scientific studies show, this Cuban vaccination scheme has a protective effect of 92.4 percent.

The vaccine alone was not enough to bring the virus under control. Stringent containment measures – wearing masks, strict adherence to physical distancing, and a radical lockdown until November 15, 2021 – were necessary to control the spread of the virus. As a result, Cuba recorded only one death linked to COVID-19 in the last week of November and a transmission rate of less than 1%. Even today, despite low numbers, rules to minimize transmission of the virus are respected across the island.

What exactly is Soberana?

Soberana Plus is designed for people recovering from the virus or who have already been given another vaccine. Soberana is a protein vaccine, unlike Pfizer or Moderna, which use mRNA technology. Cuba has thus used a conventional technology based on the platform of already known vaccines for the development and production of its own vaccine. This means that in Cuba, traditional technology is used to put a small piece of the virus – the so-called “spike” – into the vaccinated person, who then produces the necessary antibodies. The mRNA vaccines, on the other hand, provide the ‘instructions’, the body learns them and raises the antibodies.

Studies carried out so far show that Soberana Plus is an absolutely effective vaccine. It builds up a very high wall of antibodies, both in those who have already been infected and recovered, and in those who have received other vaccines. Soberana Plus is also effective against the Beta and Delta variants, the former being extremely aggressive and the latter now being the worldwide dominant variant. Moreover, clinical studies showed that the vaccine has almost no side effects: less than 1% of the vaccinated population suffers from fever, reddening of the injection site, general malaise, and/or erythema.

From the perspective of global control of COVID-19, the Cuban vaccine has two other key advantages. First, its production costs are extremely low. This means that the vaccine can potentially be produced in any corner of the world (Iran is already producing a vaccine based on Cuban technology), even in countries whose per capita healthcare expenditure is less than $20 per year, which would be as much as the cost of a single Pfizer vaccine dose. Second, the Soberana vaccine has no special logistical requirements; no advanced or costly technology is needed to store and transport the vaccine.

Soberana was designed as a children’s vaccine

There is more: Cuba is the country furthest ahead in the vaccination campaign for the pediatric population. It has already vaccinated more than 2 million children and adolescents aged between 2 and 18. Indeed, Soberana02 is a product originally designed for children. While at the beginning of the pandemic, experts and governments around the world were rushing to say that the virus would not affect children, scientists in Cuba were working to ensure that none of them actually died or were intubated because of COVID-19. “For us it was clear that no child should die from COVID-19. That’s why a vaccination program for children that was planned in detail was of central importance,” explained Ricardo Pérez Valerino, Head of International Relations at the Finlay Institute.

Pérez Valerino added, “It’s true, children cope with the virus better than adults, but they are vectors of the disease. Our grandparents, adults were getting sick and sometimes the virus was carried by their grandchildren and children. At the same time, however, we started to see that even the youngest children were getting sick. So the ideal thing was to have a vaccine that worked and was safe for our children too.”

In Western countries today, new infections are actually increasing in the younger population, which led to school closures in Germany, Italy and other countries. In the United States, for example, children accounted for 25.1% of the weekly reported COVID-19 cases in November 2021. In Italy, more than 30% of new Corona cases around the same time were currently in minors, with children between 6 and 11 years of age particularly affected. Many Western countries – above all the US and Italy, but also other countries in the European Union – have already started vaccinating minors.

Cuba is also a pioneer in this respect. First of all, a vaccine against Sars-Cov-2 was developed on the basis of vaccines already used in infants, which reduced the health side effects and problems of the new vaccination to practically zero and strengthened parents’ confidence in the new vaccine. Second, the entire population – including children – was integrated into the vaccination campaign from the very beginning, which can be defined as forward-looking in view of the latest developments in the pandemic.

International cooperation against the pandemic

“The Cuban vaccine and its vaccination campaign are not the result of any miracle, but the consequence of political decisions,” said Fabrizio Chiodo, an Italian scientist who collaborates with the Cuban Finlay Institute in developing the vaccine and is part of the clinical collaboration between Cuba and Italy. He added, “If in the global struggle against the pandemic we are looking to Cuba and to its vaccines today, it’s because Cuba was visionary in developing a public healthcare system and public biotechnological research.”

Public versus private is not simply an ideological question. The small Caribbean island, under a blockade for more than 60 years, was able to develop three vaccines and two vaccine candidates in a very short time because Cuba didn’t surrender itself to the logic of multinational corporations and Big Pharma, but invested in public healthcare and educational and research systems which guaranteed top quality professionals.

In mid-September 2021 – shortly after the start of the vaccination program on the island – Cuba applied for approval of its vaccine at the World Health Organization (WHO). For the international recognition of Soberana, the Cuban government deliberately decided against applying for approval at the European Medicines Agency EMA and the US Food and Drug Administration FDA. The rejection of the Chinese Sinovac and the Russian Sputnik by EMA and FDA are proof that these agencies make political decisions. However, in the perspective of global cooperation against the pandemic, in Cuba, only the WHO is recognized as a multilateral, neutral body.

Cuba’s handling of the COVID-19 pandemic is thus a lesson for the whole world: it puts people’s health before private profits, promotes international cooperation and strictly rejects trade wars between states and multinational corporations. It would therefore be a fatal mistake to disregard the Cuban experience with regard to a globally united fight against COVID-19.

The author is one of the participants in the clinical trial mentioned in the story.