MIAMI, United States. – In the middle of an unprecedented economic crisis, the Cuban regime is clinging to its vaccine candidates against the coronavirus in order to remedy the health crisis the pandemic is leaving in its trail. After a year of relative calm following closure of its borders –during which time the island reported relatively low numbers in deaths and contagion- the transmission of the virus skyrocketed in 2021, reaching 854,167 cases[i] and 7,227 fatalities.[ii]
Although Cuba confirmed the first case of COVID-19 in March of 2020, it was not until August that the island’s authorities spoke about Soberana 01, the first national vaccine candidate, produced by Instituto Finlay de Vacunas, IFV (Finlay Vaccine Institute) in collaboration with Centro de Inmunología Molecular and Centro Nacional de Biopreparados (Center for Molecular Immunology and National Biopreparations Center, respectively).
Since then, five other vaccine candidates have received national attention: Soberana 02, Abdala, Mambisa, Soberana Plus and Soberana 01A. Three of them, Soberana 02, Abdala and Soberana Plus, already have emergency-use authorization nationally.
However, several months after a massive vaccination campaign started in the country, and with almost half of the population fully vaccinated, reports about these pharmaceuticals generate doubts about their efficacy and about their capability of putting an end to the nightmare Cubans are facing.
Emergency use and efficacy
Cuba’s BioCubaFarma, the corporate organization that produces pharmaceuticals, equipment and high-technology services, assured the public in June that the vaccine candidate Abdala had shown 92.8% efficacy in preventing symptomatic illness after administration of three dosages. This data was obtained in Phase III of Clinical Trials, just before being approved for emergency use.
Three weeks later, Centro de Ingeniería Genética y Biotecnología de Cuba, CIGB (the Center for Genetic Engineering and Biotechnology) informed the public that Abdala had shown 100% efficacy in preventing severe systemic COVID-19 illness and death.
Something similar happened with Soberana 02, a vaccine candidate that showed 91.2% efficacy for prevention of symptomatic illness after administration of three dosages, the third dosage using Soberana Plus as reinforcement. Soberana Plus is another vaccine produced in the country.
In all cases, they deal with vaccine projection subunits that, according to Cuba’s scientific authorities, utilize proteins derived from the virus mixed with other carrier proteins to produce an immunity reaction.
The first one to be approved for emergency use was Abdala. The Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos de Cuba, CEDMED (Regulatory Authority of Medicines, Equipment and Medical Devices of Cuba), through Resolution No. 113 dated July 9, 2021, approved the extended use of this vaccine, which was already being administered to the population. Back then, CEDMED indicated that the vaccine met “the obligatory requirements and parameters regarding quality, safety and efficacy with respect to this request.”
Something similar occurred last August 20th, when the same entity authorized emergency use (the AUE, by its Spanish acronym) for Soberana 02 and Soberana Plus.
The efficacy results for these vaccine candidates during Phase III Clinical Trials were used immediately by the propaganda apparatus of the Cuban regime, which wasted no time to emphasize that the percentages each vaccine showed placed them among the best qualified vaccines in the world to fight COVID-19, almost on par with Pfizer-BioNTech (95%) and Moderna (94.1%) and way better than other vaccines, like the one produced by Oxford University and AstraZeneca (72%-74%).
The results published by Cuba’s scientific authorities projected that there would be a gradual improvement in the epidemiological situation. However, statistics published by the Ministry of Public Health (MINSAP) kept rising during the second quarter of 2021. Contagion and hospitalizations increased, as did coronavirus fatalities. This has cast doubts on the real impact of the vaccination process in the island.
Vaccines, deaths and inconclusive cases
In mid-August, Eduardo Martínez, President of the BioCubaFarma corporate group, told on the national television newscast that, of the 2.5 million Cubans vaccinated against COVID-19 up to that point with the domestic vaccines, 99 had died and 21,000 had taken ill with the virus.
Based on those results, Martínez described as “outstanding” the vaccination statistics, pointing out that vaccinated individuals who had caught the virus accounted for less than 1%, and that the 99 fatalities represented 0.003% of the vaccinated.
The official also blamed the Delta variant for the increase in virus transmission in the island, while assuring the public that the Cuban vaccines were protecting patients from severe manifestations of the illness.
“There is substantial evidence that shows that vaccines in general and the Cuban vaccines in particular are protecting people from COVID-19, from severe systemic illness,” stated Martínez on that occasion.
Since then, Cuban authorities have not shared new information about individuals who have died after being vaccinated. The majority of deaths and adverse patient results reported have appeared on social media, where not few Cubans have questioned the efficacy of the Cuban vaccines.
Reports from physicians inside the island and abroad warn about adverse results related to the pandemic, a reality that is not Cuba’s alone, but that the official state press has kept hidden.
In late August, Dr. Alexander Figueredo assured CubaNet that he had received reports of people dying after being vaccinated.
“I am receiving many reports because the fatalities have been many. I am simply gathering data about all those patients: when they were vaccinated, what where the symptoms and what caused their death. In Granma province, there are many patients that have had adverse reactions after the first and the second Abdala vaccine dosages, stated Figueredo.
Among the groups affected by the pandemic in the island are pregnant women or those already in childbirth and the post-partum period. Some of them have been vaccinated with the Cuban vaccines against COVID-19.
Application of the latter also has generated doubts among specialists outside the island. For example, Dr. Alfredo J. Melgar, a Miami physician, has questioned the validation procedures that authorized the use of those vaccines on pregnant women.
“How could a pregnant woman in the second or third trimester of pregnancy be vaccinated with vaccines that have not been certified internationally by any institution? Who validates the efficacy of those vaccines? And beyond their efficacy, who is held accountable for the adverse reactions they cause? This is highly worrisome,” he concluded.
As far as Dr. Melgar is concerned, that is “an irresponsible procedure” on the part of medical authorities, which can leave damages not only to the mother but also to the soon-to-be-born baby “who may or may not die, but can suffer complications later on”.
Twenty-four-year-old, Cienfuegos-born, Yeleinis Ruiz Padrón, lost her baby after she was vaccinated with one of the Cuban anti-COVID-19 vaccines.
The young woman, who resides in the town of Juraguá –site of Fidel Castro’s aborted nuclear plant project- said to CubaNet that after eight months “of a perfect pregnancy,” a series of complications apparently resulting from the anti-COVID-19 vaccine made her miscarry what would have been her first child.
“I got pregnant in November, a perfect pregnancy. I had no problem with my blood pressure, or with anything. It was a perfect pregnancy until July 30, 2021, when I was vaccinated. At midnight on July 31st, after being administered the vaccine, I started discharging fluids,” explained Ruiz Padrón, who lost her baby a few weeks later.
Months before, in May, the digital portal Cibercuba published information about a 41-year-old woman who was hospitalized at Hospital Clínico Quirúrgico -aka La Dependiente– in the municipality of Diez de Octubre, with an adverse reaction to the Abdala vaccine while this candidate was still in the process of Phase III clinical trials.
The patient was hospitalized with high fever, respiratory problems and fatigue, immediately after receiving the second dosage of the vaccine.
Cuba: vaccination statistics
Statistics compiled by the digital portal Our World in Data based on the registries kept by Cuban health authorities indicate that, up until September 23, 2021, 42.96% of the country’s population was fully vaccinated against COVID-19 with one of the domestic vaccines, and of those, 34.93% had been administered at least one vaccine dosage.
The statistics indicate that 77.89% of vaccine coverage had been attained by the Caribbean country, with a total of 19.8 million dosages already administered.
Although Abdala, Soberana 02 and Soberana Plus have been categorized as vaccines by CEDMED, and although several batches of these vaccines have been approved for use in countries such as Venezuela and Vietnam, to date, the World Health Organization (WHO) has not authorized extended global use of the island’s vaccine candidates.
[i] Statistics updated as of September 25, 2021
[ii] Statistics updated as of September 25, 2021