CAJICA, Colombia - The Cuban government announced the successful development of a COVID-19 vaccine, but little is known about it beyond announcements that it has already started phase I trials.

Cuba’s ruling regime appears confident of the outcomes of the trials that started in August and that aim to demonstrate the vaccine´s safety and efficacy in preventing the new coronavirus. The island nation is looking for partners, but for now, little information on the vaccine has been released to the international community.

“The vaccine is a monovalent vaccine and it is very similar to the Oxford vaccine. It is not the same as the Russian vaccine, which is a polyvalent one, so the Russian vaccine seems likely to be more reliable,” Eugênio Aragão, former minister of justice of Brazil and legal advisor to Brazil´s opposition party, told BioWorld.

Aragão has been involved in the negotiations between some Brazilian states with Russia to test and distribute the Sputnik V vaccine in the Latin American giant. And, due to his role helping governments like the one of the Brazilian state of Bahia secure access to a vaccine, he is well aware that Cuba would like to bring its vaccine to Brazil for trials. Brazil is third in the world for COVID-19 cases with more than 4.457 million infections.

However, the lack of information on the Cuban vaccine or the results of the trial, as well as the politics behind it, could harm Cuba´s plans.

“I think that knowing history is key to understanding the present and foreseeing the future,” Carlos Rodriguez, a former member of Cuba’s Communist Youth, told BioWorld. “I do not know of an occasion in the history of six decades of the revolution where the government has recognized an error in a Cuban project.”

Rodriguez even met former ruler Fidel Castro but defected 20 years ago and now lives in Costa Rica, where he now works as a project manager and education consultant.

“Creating a vaccine is a risky undertaking,” Rodriguez said. “Entrepreneurships must be developed in a scenario where failure, and learning from mistakes, is possible. But failing in the case of a Cuban political project seems, due to its history, to be out of the question.”

In Cuba, the Finlay Institute in Havana is responsible for developing Sovereign-01, the vaccine with a politically charged name. Even the country's president, Miguel Díaz-Canel, made reference to the name of the vaccine: “The name of the vaccine reflects the feeling of patriotism and revolutionary and humanist commitment with which the people have worked. Exploits like these reaffirm our pride in being Cubans,” he said in comments published by the state´s media.

Inside Cuba, there is a political narrative for the vaccine, one tied to Castro.

“The #CubanVaccineCOVID19 is dedicated to the sower of dreams: Fidel. Our tribute to the one who believed in the strength and future of #CubanScience,” tweeted the Finlay Institute in August, days before starting phase I trials.

Regardless of how effective the vaccine is or isn’t, its development is tied to the country’s politics.

“Cuban sciences is [sic] the result of Fidel´s visionary capacity. He was so clear how strategic could be the biotechnology sciences for the future [sic]. Today, he is with us, looking for every results [sic], for every dream. #Soberana is your dream,” tweeted in English by Dagmar Garcia, research director at the Finlay Institute.

Neither Garcia, nor BioCubaFarma, the institution that groups the country's drug biotech sector, responded to requests for comment from BioWorld. According to official information, the country started phase I trials last month. It administered the dose to 20 volunteers ages 19 to 59. More than 670 volunteers on the island are expected to participate in the first two phases of the trials.

According to the information disclosed by the Finlay Institute to the Cuban Public Registry of Clinical Trials: “The administration of the vaccine is expected to be safe, admitting no more than 5% of individuals with serious adverse events (SAEs) with a causal relationship consistent with vaccination.”

Finlay expects the proportion of subjects with an immune response to be at least 50% higher than the control group.

The phase I/phase II study is expected to end in mid-January 2021, according to information released by the Finlay Institute. It expects to publish the results by February 2021. Those results will determine whether the Cuban vaccine is able to start phase III trials abroad. A country like Brazil could be a location, but chances of a trial in the South American nation are low.

Brazil has become a magnet in the region for phase III trials due to the amount of infections from SARS-CoV-2 that the country has registered, which combined with the strengths of Anvisa, the Brazilian health surveillance agency, have placed the country in the sights of pharma companies racing for a COVID-19 vaccine.

Former minister Aragão is not very optimistic about the future of phase III trials of a Cuban vaccine in his country.

“I think that we will have enormous difficulty in registering a Cuban vaccine in Brazil, because of political reasons. That's the reality,” he said. “I don't know if the government of Bolsonaro is willing to do any kind of deals with the Cuban government,” he explained.

“We still have to look for more information about the Cuban vaccine, because the Cubans are eager to distribute it, but we don't have yet the necessary information.”

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