CAJICA, Colombia – Cuba’s Finlay Institute of Vaccines is moving forward with Soberana 2, a domestically developed conjugate vaccine against SARS-CoV-2.

This is the second vaccine under development in the small country of 12 million people. The country’s first vaccine, Soberana 01, is currently undergoing phase I/II trials in Cuba. Soberana 01 is a monovalent vaccine.

“Cuba has a lot of experience with conjugate vaccines…their heptavalent antipneumococcal vaccine is based on this technology,” Fabrizio Chiodo, research assistant professor at the Italian National Research Institute (CNR) since 2013 and close collaborator and researcher with the Finlay Institute, told BioWorld.

Chiodo is deeply involved in the development of the Soberana (“sovereign” in Spanish) vaccines in Cuba and is confident of the preliminary results from early clinical trials.

“Soberana 2 gives higher hopes, not only about the safety in children and in infants and in elderly population, because you boost in a better way the immune system, but from an immunological point of view all these immune systems that are weaker, from the elderly population, children and infants, will have a lot of benefit in having the conjugate vaccine,” he explained.

The Cuban Public Registry of Clinical Trials currently records three SARS-CoV-2 vaccine trials in the country, all from the Finlay Institute: two trials are for Soberana 1, with different dosages, and one is testing Soberana 2, whose preliminary results are, according to Chiodo, encouraging.

“From a technological and academic point of view, Soberana 2 is an extremely more novel vaccine and this is why we are running immediately on the publication. I'm helping Finlay a lot, discussing it, to have it submitted already by the end of November,” he said.

“The preclinical results are exciting,” he said, adding that a paper with the results is being prepared to submit “to classic, very good journals we hope. The preclinical? It was brilliant.”

Soberana 2 phase I trials were registered in the island´s registry on Oct. 27. The Finlay Institute aims to test the vaccine candidate in two different groups with differing doses of the conjugated vaccine in 40 participants between the ages of 19 and 59.

The trial is expected to end by Jan. 6, 2021, and its results to be published by March 15 at the latest, but the timing could be faster given the global race to find a vaccine.

“The vaccine could be in the market after the first three or four months of 2021,” said Chiodo.

“This is not one phase after the other, there is a lot of overlap, so things can really go faster. There are ways of letting know all the controlling agencies that the situation is very safe and we can go faster. This is what happened for Pfizer and Moderna, for example,” he said.

According to Chiodo, Cuba has enough capacity to manufacture vaccines for its entire population.

“For pneumococcal vaccine, Cuba can already produce from 2 to 3 million doses per year,” said Chiodo. “It is a platform that already has a lot of flexibility, to up-regulate let's say, the doses. So, yes, it is possible to manufacture the Soberana 2, and production can be bigger.”

Technology transfer deals across Latin America and even with European and Asian countries, could help boost Cuba’s plans to reach global markets, particularly those that may not be served or quickly covered by the global frontrunners in COVID-19 vaccine development like Pfizer Inc. and Biontech, Moderna Inc. or China’s Sinovac Biotech Ltd.

“Physically transferring them is also very interesting. These are very stable molecules, as far as we know, at four degrees [Celsius],” said Chiodo.

Cuba is one of the four Latin American countries where scientists are working to develop a SARS-CoV-2 vaccine. Researchers in Argentina, Mexico and Brazil are working on one.

“We remain committed to having a great part of the Cuban population vaccinated [against SARS-CoV-2] during the first half of 2021,” said Vicente Vérez, head of the Finlay Institute, in an interview with a local Cuban TV channel in mid-November.