“We are seeing a safety profile with the vaccine [Soberana 2] that is very good,” Dr. Vicente Verez, director of the Finlay Institute of Vaccines, told NBC News.
NBC News, April 10, 2021, 3:35 PM EDT
By Orlando Matos and Carmen Sesin
HAVANA — Cuba is “betting it safe” with the later development of their own Covid-19 vaccines and encouraged by what they’re seeing in late stage and experimental studies, a top Cuban vaccine scientist said.
If the trials are successful, the relatively small, communist island of 11 million — that has been sanctioned by the United States for decades — would be one of just very few countries with vaccines to fight the coronavirus pandemic, drawing worldwide attention to its potential feat.
The other countries that have developed vaccines, including the United States, the United Kingdom, China, Russia and India, have significantly larger economies and population sizes.
Two of Cuba’s five vaccine candidates are in Phase 3 trials: Soberana 2, which translates to ‘sovereignty,’ and Abdala, named after a book by the Cuban independence hero José Martí.
Around 44,000 people are getting the Soberana 2 vaccine as part of the Phase 3 double-blind study. An additional 150,000 health care workers are being inoculated with Soberana 2 as part of an “interventional study.”
Unlike the mRNA vaccines from Pfizer-BioNTech and Moderna, the Soberana 2 uses synthesized coronavirus proteins to trigger the body’s immune system.
“We are seeing that the vaccine is very safe, the potential risk for applying it to more people is decreasing, and the potential benefits are increasing. There is evidence of certain efficacy and that is why we decided to expand the interventional studies,” Dr. Vicente Verez, director of the Finlay Institute of Vaccines, told NBC News. The institute is named after the Cuban epidemiologist Dr. Carlos Finlay who discovered yellow fever is transmitted through mosquitoes.
The institute was established in 1991 by the late Cuban leader Fidel Castro who invested heavily in the country’s health care system and pharmaceutical sector. Its cancer research center developed a vaccine being tested in the United States and other countries.
In Cuba, “we began a bit later than the rest of the vaccines [in the world] because we had to wait and know a little more about the virus and the mechanism though which it infects cells,” Verez said. “We are seeing a safety profile with the vaccine [Soberana 2] that is very good.”
With its economy ravaged by the pandemic, decades of sanctions and a decline in aid from its ally Venezuela, the island has been grappling with shortages in food and medicine. Its economy shrank 11 percent in 2020. But it has managed to keep the number of Covid-19 infections and deaths down with strict measures and lockdowns, compared to many developed countries around the world. In recent weeks, the country has averaged around 1,000 cases per day, but it had very low infection rates last year.
The final results of the Phase 3 trials are not expected for months. The government’s plan is to have nearly all the inhabitants of the capital, Havana, vaccinated by May through the interventional study, and the entire country’s population inoculated before the year ends.
Verez said that while the vaccination won’t be mandatory, he thinks “the immense majority of the population wants the vaccine.”
For Cuba, the vaccine is as much about public health as it is a show of force; that a small communist country sanctioned by the U.S. can compete on the world stage with its own vaccine candidates. Cuba could have acquired vaccines from its allies, China and Russia, but developing its own gives it the opportunity to sell vaccines to underdeveloped countries that have seen few doses, giving it a source of badly-needed hard currency. As U.S. and British vaccines advanced in clinical trials last year, wealthy countries in North America and Europe preordered large quantities, leaving poor and developing countries with a large gap in access.
Verez said some countries have approached Cuban officials with the intent to purchase more than 100 million annual doses of some of its vaccines. He said Cuba’s vaccine production system is being reorganized to produce 100 million doses. Iran, which banned U.S. and British vaccines, will host a Phase 3 trial of Soberana 2 as part of an agreement that includes producing millions of doses there. Venezuela will produce Abdala vaccines, its government announced Thursday. Mexico and Argentina have also expressed interest in Cuba’s vaccines.
“They are very safe,” Dr. Eduardo Martínez Díaz, president of the state-run BioCubaFarma, said in emailed responses to questions. “After applying thousands of doses, only slight and moderate side effects were seen in a small percentage of volunteers.”
Díaz added that both vaccines are creating a high amount of immunity. If exported, the prices would be affordable, he said.
Verez said the vaccines will be adapted to the new variants, and extra doses could be required to boost immunity.