Coronavirus Vaccine Nears Ultimate Exams in Cuba. Vacationers Might Be Inoculated.

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Coronavirus Vaccine Nears Final Tests in Cuba. Tourists May Be Inoculated.

HAVANA – People wait four hours in line to buy detergent in Havana. There are no more painkillers in Cuban pharmacies. There is a national shortage of bread.

Yet the Cuban government says it is facing an extraordinary scientific achievement: the mass production of a coronavirus vaccine invented on the island.

One of the four vaccines developed by Cuban scientists will enter a final phase of testing next month. This is a critical step toward regulatory approval that, if successful, could get the island off the ground to vaccinate its entire population and begin exporting overseas by the end of the year.

If the vaccine proves safe and effective, it would bring the Cuban government a major political victory – and an attempt to save the nation from economic ruin. For a country that has for decades touted its sophisticated health system as evidence of the benefits of socialism, the vaccine also provides a unique public relations opportunity.

The vaccine headed toward a final phase of trials is called Sovereign 2, a nod to the island's pride in its autonomy despite decades of hostility towards its northern neighbor. Cuba already has the idea of ​​luring tourists to the coast with the irresistible cocktail of sun, sand and a setting of Sovereign 2.

Vicente Vérez, one of the scientists on the team that developed the vaccine, said the island could offer vaccinations to all foreigners who travel there.

“It's not just medicine and humanity; it's a big economic payoff if they can get the virus under control,” said Richard Feinberg, a Cuba expert at the University of California at San Diego. “It won't just be an instant one Income, but also strengthen the reputation of the Cuban pharmaceutical biotech sector, which enables them to market other medical products. "

Cuban scholars say the government is likely to dump some doses to poor countries, in line with its longstanding practice of strengthening international ties by donating medicines and sending doctors to deal with public health crises overseas.

"Cuba has always donated vaccines," said Gerardo Guillén, a scientist who develops two of the four vaccines at the state's genetic engineering and biotechnology center. "We help other countries."

Cuba began pouring money into biotechnology in the 1980s as part of Fidel Castro's quest to make the nation self-sufficient in the face of a US embargo that made it difficult to obtain medicines made abroad.

Investment in public health has resulted in dozens of medical research institutions and a surplus of doctors sending Cuba on medical missions to other countries.

In 2019, leasing doctors, nurses and technicians grossed $ 5.4 billion, twice as much as tourism, a major engine of the economy.

The island's biotech sector is also well developed. Cuba manufactures eight of the twelve vaccines given to children on the island and exports vaccines to more than 30 countries.

"It's a biotech juggernaut," said Gail Reed, editor of MEDICC Review, an expert-reviewed journal of Cuban medicine and medicine from developing countries, of the island. "The performances are undeniable."

Updated

Feb. 17, 2021 at 4:26 p.m. ET

Cuban scientists have also developed innovative therapies, including a lung cancer vaccine that is currently being tested with the New York-based Roswell Park Comprehensive Cancer Center.

"Sometimes, because it's Cuba, people think they just make these drugs in their garage and give them to people, and that's not true," said Candace Johnson, president of Roswell Park. "They practice very precisely to the same high standards as any other country that makes these drugs."

Ms. Johnson said Cuban scientists showed they "met all appropriate standards and controls" before she could bring the lung cancer drug to New York.

Manufacturing the coronavirus vaccine has been made more difficult by the Trump administration's tightening of sanctions against Cuba. Scientists say they couldn't buy all of the equipment and raw materials they needed, including the spectrometers used for quality control. The two research groups working on the drug only have one powerful enough to analyze the vaccine, said Dr. Guillén, and she is around 20 years old.

"Not only can Cubans make old cars work, they can also make old devices work," said Mitchell Valdes Sosa, director of the Cuban Center for Neuroscience.

The Sovereign 2 vaccine has undergone two phases of testing and is slated to enter a third phase in which it will be tested on around 150,000 people in Cuba and Iran who have shown interest in purchasing the drug. Mexico is also in talks with the Cubans to participate in the third phase of the trials.

Like the vaccine being developed by Novavax, a US company, Sovereign 2 is a protein-based vaccine that contains part of the coronavirus. It requires three doses given at two-week intervals and, unlike the Moderna and Pfizer vaccines, does not need to be frozen – which can be a disadvantage for poorer countries that often lack the equipment to keep so many doses frozen .

Dr. Vérez said in a text message that Sovereign 2 is "very safe with very few adverse effects," a prerequisite for moving into a third and final phase of studies. Scientists will not publish their rate of effectiveness until the studies are complete. It is still unclear whether the vaccine will protect against new variants, one of which has already been discovered on the island.

The government is optimistic and boasts of being able to produce 100 million doses this year, more than enough to inoculate the entire country with 11 million and possibly foreign visitors.

But Cuba may not have the necessary equipment to manufacture its vaccine on this scale. US sanctions have increased the cost of purchasing raw materials and made it difficult to transfer funds to the island.

"It could be difficult to buy enough vials for your 100 million cans," said José Luis DiFabio, the former World Health Organization representative in Cuba. "Or if you have equipment that needs to be fixed, you don't have access to the parts you might need. Or instead of getting something in a week, you can 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 early on, relying on tight population controls and an efficient system of health care delivery. Everyone diagnosed with the virus was immediately hospitalized and treated with a cocktail of Cuban and generic drugs.

The government isolated their close contacts and monitored them for symptoms. Cuba reported only 12,225 confirmed coronavirus cases and 146 deaths in 2020, which is among the lowest rates in the Western Hemisphere.

After the decision to open international air traffic after a seven-month closure in November, the number of cases rose. Authorities are now fighting the worst outbreak since the pandemic began. January saw more cases than all of last year, and a 9:00 p.m. was recently set. Curfew in Havana.

The government hasn't announced any concrete plans for vaccinating tourists yet, but needs to consider how long it would take to get all three Sovereign 2-mandated shots fired.

Dr. Guillén said instead of tourists staying on the island for a month and a half, tourists could be given the opportunity to take a shot on the island and pack the other two doses in their suitcases for home vaccination.

The plan to open vaccination to tourists seems like a risky and shrewd capitalist game for some to attract visitors, and with them the hard currency the island desperately needs. The combination of the pandemic and sanctions has caused the worst economic crisis the country has seen since the fall of the Soviet Union in the 1990s, experts say.

However, Cuban scientists insist that the goal is to spread health. Every win, they say, is just a side effect.

"We're not a multinational company where return on investment is our top priority," said Vérez, who leads the vaccine development, at a recent press conference. "Our first priority is creating health and return on investment is a consequence of it."

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