Sovereign 2: Cuba, closer and closer to the mass production of its vaccine

HAVANA.- People line up for four hours to buy detergent in Havana. Cuban pharmacies do not have pain medication. There is a national shortage of bread.

And even the Cuban government says it is on the verge of an extraordinary scientific achievement: the mass production of a vaccine against the coronavirus invented on the island.

One of the four vaccines developed by Cuban scientists will enter the final phase of testing next month. a crucial step towards regulatory approval which, if successful, could put the island on the path to inoculating its entire population and starting its overseas exports by the end of the year.

If the vaccine proves safe and effective, the Cuban government would gain a major political victory and an opportunity to save the nation from economic ruin.. For a country that for decades has touted its sophisticated healthcare system as proof of the benefits of socialism, the vaccine also offers a unique public relations opportunity.

The vaccine which enters a final phase of testing is called Sovereign 02, in a nod to the island’s pride in its autonomy, despite decades of hostility from its northern neighbor. Cuba is already thinking of attracting tourists to its shores with an irresistible mix of sun, sand and a dose of Soberana 02.

Vicente Vérez, one of the scientists leading the team that developed the vaccine, said the island could offer vaccines to all foreigners who visit it.

“It’s not just medicine and humanitarianism; there is a great economic benefit if they can get the virus under control, ”said Richard Feinberg, an expert on Cuba at the University of California, San Diego campus. “This will not only be an immediate entry, but a strengthening of the reputation of the Cuban pharmaceutical biotechnology sector, which will allow it to commercialize other medical products.”

Cuban scientists say the government will likely distribute some doses to poor countries, in line with its long practice of strengthening international relations by donating medicine and sending doctors to fight public health crises abroad.

“Cuba has always donated vaccines,” said Gerardo Guillén, a scientist who develops two of the four vaccines at the National Center for Genetic Engineering and Biotechnology. “We are helping other countries.”

Invest in biotechnology

Cuba began investing money in biotechnology in the 1980s, as part of Fidel Castro’s drive to make the nation self-sufficient in the face of the US embargo that made it difficult to obtain drugs produced abroad. .

Investments in public health have given rise to dozens of medical research institutions and a surplus of doctors, which Cuba sends to other countries on medical missions.

In 2019, the hiring of doctors, nurses and technicians brought in 5.4 billion dollars, double the rate of tourism, one of the main engines of the economy.

The island’s biotechnology sector is also well developed. Cuba manufactures eight of the 12 vaccines administered to children on the island and exports vaccines to more than 30 countries.

“It’s a biotechnology monster,” Gail Reed, editor-in-chief of MEDICC Review, a Cuban and developing-world medical journal, said of the island. “The achievements are undeniable.”

Cuban scientists have also developed innovative treatments, such as a vaccine against lung cancer tumors, which is being tested with the Roswell Park Comprehensive Cancer Center in New York.

“Sometimes people think because it’s Cuba they just make these drugs in a garage and give them to people, and that’s not true,” said Candace Johnson, president of Roswell Park. “They use exactly the same high standards as any other country that makes these drugs.”

Johnson said Cuban scientists had demonstrated that they “follow all the rules and all the proper controls” before bringing the lung cancer drug to New York.

Punishments

The production of the coronavirus vaccine has been complicated by the tightening of sanctions against Cuba by the government of Donald Trump. Scientists say they haven’t been able to buy all the equipment and raw materials they need, including the spectrometers used for quality control. The two research groups working on the drug only have one powerful enough to test the vaccine, Guillén said, and he’s around 20 years old.

“Not only can Cubans run old cars, but they can run old equipment as well,” said Mitchell Valdes Sosa, director of the Cuban Neuroscience Center.

The Sovereign 02 vaccine has passed two phases of testing and is about to enter a third phase, during which it will be tested on some 150,000 people in Cuba and Iran, who have expressed interest in it. acquisition of the drug. Mexico is also in talks with the Cubans to participate in the third phase of the trials.

Much like the vaccine developed by Novavax, an American company, Soberana 02 is a protein-based vaccine that contains part of the coronavirus. It requires three doses given at two-week intervals and, unlike Moderna and Pfizer vaccines, it does not need to be stored in a freezer, which can be beneficial for poorer countries which often lack the equipment. to keep as many doses frozen.

Verez said in a text message that Sovereign 02 is “very safe and with very few side effects,” a requirement for moving to a third and final phase of testing. Scientists will not publish their effectiveness rating until the trials are complete. It is not yet clear whether the vaccine will protect against the new variants, one of which has already been detected on the island.

Optimism in government

The government is optimistic and boasts that it can produce 100 million doses this year, more than enough to immunize the entire country of 11 million people and possibly foreign visitors.

But Cuba may not have the equipment to make its vaccine on this scale. US sanctions increased the purchase price of raw materials and made it difficult to transfer funds to the island.

“It might be difficult to buy enough vials for your 100 million doses,” said José Luis DiFabio, a former World Health Organization representative in Cuba. “Or if they have equipment to repair, they don’t have access to the parts they might need. Or, instead of getting something in a week, you get it in a month. “

And opening the doors to tourists hungry for vaccines can create new problems.

Cuba limited the spread of the virus from the start by relying on its strict population control and an effective health system. Anyone diagnosed with the virus was immediately hospitalized and given a cocktail of Cuban and generic drugs.

The government isolated its close contacts and monitored them for symptoms. In 2020, Cuba recorded just 12,225 confirmed cases of coronavirus and 146 deaths, one of the lowest rates in the Western Hemisphere.

Then, following the decision to open international air travel in November after a seven-month hiatus, the number of cases skyrocketed. Authorities are now battling the worst outbreak since the start of the pandemic, with more cases reported in January than all last year, and recently instituted a 9 p.m. curfew in Havana.

Tourists

The government has not yet announced a specific tourist vaccination plan, but it will have to take into account the time it would take to administer the three doses required by Soberana 02.

Guillén said that instead of staying on the island for a month and a half, tourists could be given the option to get the vaccine once on the island and pack the other two doses in their suitcase to get the vaccine. at their home.

The plan to open up vaccination to tourists seems, to some, a risky and cleverly capitalist tactic to attract visitors, and with them the hard currency the island desperately needs. According to experts, the combination of the pandemic and the sanctions created the worst economic crisis the country has seen since the fall of the Soviet Union in the 1990s. Almost every product imaginable – from chicken to soap – has started to break down. to lack.

Cuban scientists, however, insist that the goal is to spread health. Any benefit, they say, is simply a side effect.

“We’re not a multinational company where comeback is the main reason,” Verez, who heads vaccine development, said at a recent press conference. “We are working in reverse, creating more health and return is a consequence, it will never be the priority.”

The New York Times

More information