WHO tells Cuba to publish its COVID-19 vaccine data and to seek approval for COVAX
The Pan American Health Organization says Cuba should publish trial data on its Abdala vaccine in peer-reviewed scientific journals so that the global scientific community can evaluate the efficacy rates of the COVID-19 shot.
“Here is an invitation [for Cuba] to publish the data,” Dr. Jarbas Barbosa, PAHO’s assistant director, said in a media briefing Wednesday.
He said the organization, which serves as the World Health Organization’s Regional Office for the Americas, would welcome the inclusion of a Cuban vaccine in the U.N.-backed global sharing program, COVAX. But that can only happen after Cuba publishes its trial data and requests an emergency use authorization for its vaccine from the WHO.
“I think it’s very important that the producers of the Abdala vaccine — if they have finished all three phases of clinical trials — publish the data in a transparent way so that the scientific community can also evaluate this information,” Barbosa said.
Cuba says two of its vaccines are effective against COVID-19. But where is the data?
Cuba said last week that its Abdala and Soberana 02 coronavirus vaccines, two out of its five candidates, have shown high efficacy rates against COVID-19. BioCubaFarma, the government-owned pharmaceutical company, said that its three-dose Abdala vaccine candidate had an efficacy rate of 92.28% in Phase III clinical trials, while the state-run Finlay Institute of Vaccines said its Soberana 02 had completed Phase III trials with an efficacy rate of 62% after two out of three recommended shots.
The island has five candidates at various stages of trials after it decided to produce its own vaccines rather than be forced to compete with richer countries for shots. After the start of the pandemic last year, Cuban leader Miguel Díaz-Canel said that guaranteeing the nation’s sovereignty was the main goal of producing a homegrown vaccine, so much so that the first candidate was named Soberana, Spanish for sovereign. Abdala was named after a poem by independence hero José Martí, and a third candidate is called Mambisa, the word for 19th Century insurrectionists in the fight against Spanish rule.
The vaccines are already being administered even before receiving certification from local authorities, after a spike in cases led the government to launch an emergency intervention in May. Díaz-Canel said Wednesday that over a million Cubans have already received at least one shot of the Abdala or the Soberana vaccines.
COVID-19 case numbers have been rising steadily since late last year after Cuba reopened its borders to tourism in November. On Tuesday the island of 11 million registered more than 3,000 daily cases for the first time since the start of the pandemic, and reported 17 deaths. Total cases since the start of the pandemic reached 188,000 and 1,270 deaths have been confirmed, according to the Ministry of Public Health.
Barbosa said if Cuba wants to provide its vaccines to the U.N. vaccine-sharing platform, it will have to open up its labs and production facilities for WHO inspections so that technical staff can verify whether installations are following best practices in vaccine production.
He also said that PAHO recommends that all countries making their own vaccines should be forthcoming with information about the trials and production process to boost confidence in their immunization programs.
Cuba shipped the first batch of Abdala shots to Venezuela last week, according to a tweet by the Cuban Foreign Affairs Ministry. In a statement, the ministry didn’t specify how many doses were sent, but said that Venezuela had signed a contract to purchase 12 million doses of the vaccine.
