Cuba Starts Using Its Covid Vaccines Before Completing Trials

HAVANA – Cuba launched a mass vaccination campaign in the capital, Havana, on Wednesday with authorities trying to vaccinate 1.7 million people. The campaign uses local vaccines that have not yet been shown to work. This is an emergency step to contain the rapid spread of the coronavirus.

The country’s decision to use undetected vaccines reflects the early adoption of vaccines in Russia, China, and India, where regulators allowed mass vaccination campaigns to begin prior to the completion of Phase 3 clinical trials that test the vaccine’s efficacy and safety were rated.

In Florida, the Cuban government was accused of critical news reports that it had jumped the gun and put public health at risk. American and European health regulators will not allow emergency vaccines to be introduced until phase 3 clinical trials are completed.

Although Cuba’s daily coronavirus case numbers remain low by Latin American standards, they have increased alarmingly in recent months. The island, which had 12,225 confirmed cases reported in 2020, had 31,465 confirmed cases in April 2021 alone.

The rapid spread of a variant of the virus, first discovered in South Africa, has contributed to a surge in cases in Cuba and, according to the country’s Minister of Health, Dr. José Angel Portal, the early widespread use of the Sovereign 2 and Abdala vaccines.

“Confirmed cases are expected to increase,” he said. “Our regulators and health professionals believe that the benefits of this intervention outweigh the risks.”

Scientists rely on phase 3 studies that compare a vaccine with a placebo to see if vaccines are working. Cuba intends to complete trials for the two vaccines by June.

Cuban scientists argue that more than 145,000 Cubans who have already been vaccinated through clinical trials and an “intervention study” with health workers already have enough data to know that serious vaccine side effects are rare.

Unlike American and European vaccines, which were developed in a novel way, “the technological platform on which Cuban vaccines are based has been used for 30 years,” said Dr. Gerardo Guillén, who led the development of the Abdala vaccine. He said Cuba’s vaccines were “known to be very safe” and the technology’s proven track record “was taken into account” in the decision.

Cuba hopes to be able to produce enough cans for the entire population by August. However, scholars say US diplomatic and economic sanctions are slowing production, making it difficult for Cuba to do business with overseas suppliers, and making international humanitarian initiatives difficult to donate syringes to the island, which needs about 20 million more to complete the whole Vaccinate land.

Of the 90 coronavirus vaccines currently in clinical trials worldwide, five were developed in Cuba, the smallest country where proprietary vaccines are developed and manufactured.

“We will likely be the first country to immunize its entire population with its own vaccine,” said Dr. Eduardo Martínez, President of BioCubaFarma, the state conglomerate that oversees the development and production of vaccines.