Cuba stood out during the COVID-19 pandemic by developing its own vaccines, a rare accomplishment, achieving vaccine independence. This endeavor showcased Cuba’s commitment to public health and scientific self-reliance. Its unique approach allowed it to respond with locally produced solutions, reducing reliance on international supply chains. This achievement underscored Cuba’s long-standing investment in its biotechnology sector.
Cuba’s Unique Vaccine Development
Cuba’s capacity to develop its own COVID-19 vaccines stems from a long-standing, state-led biotechnology industry that began in the 1980s. The government has consistently allocated significant portions of its budget to strengthen its capacity for biotech and pharmaceutical innovation. This commitment led to the establishment of BioCubaFarma in 2012, an umbrella organization integrating over 40 biotech and pharmaceutical enterprises.
The country’s scientific infrastructure, focused on public health and independence, enabled a rapid response to the pandemic. Cuban scientists primarily employed protein subunit vaccine platforms, a well-established and safe technology. This approach leverages the body’s immune response to a specific part of the virus, like the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein, to generate protective antibodies. Cuba’s prior success in developing vaccines for diseases such as meningitis B and hepatitis B provided a strong foundation for this rapid development.
Leading Cuban COVID-19 Vaccines
Cuba developed several COVID-19 vaccine candidates, with Soberana 02, Abdala, and Soberana Plus emerging as the leading vaccines. Soberana 02, produced by the Finlay Vaccine Institute, is a conjugate vaccine. It uniquely combines the SARS-CoV-2 receptor-binding domain (RBD) protein with tetanus toxoid, a carrier protein that helps boost the immune response. This vaccine is typically administered as a two-dose primary series.
Abdala, developed by the Center for Genetic Engineering and Biotechnology (CIGB), is a protein subunit vaccine. It targets the RBD of the spike protein to trigger an immune response. Abdala is administered in a three-dose schedule, with doses given 14 days apart.
Soberana Plus, also from the Finlay Vaccine Institute, is a protein subunit vaccine that uses a dimeric form of the RBD protein. It is primarily used as a booster dose following the Soberana 02 primary series, typically administered 56 days after the first Soberana 02 shot. Soberana Plus has also been studied as a single-dose vaccine for individuals who have recovered from COVID-19.
Effectiveness and Safety Data
Clinical trials for Cuba’s COVID-19 vaccines have reported favorable efficacy and safety profiles. For Soberana 02, initial Phase III trial results in Cuba showed an efficacy of 71.1% after two doses against symptomatic COVID-19. When a third dose of Soberana Plus was added to the Soberana 02 regimen, the efficacy against symptomatic disease increased to 92.4%. This heterologous three-dose regimen also demonstrated 100% efficacy against severe disease and death in the trial setting.
Abdala’s Phase III trials (over 48,000 participants) reported 92.28% efficacy against symptomatic COVID-19 and 100% efficacy against severe disease and death. Adverse reactions for both Soberana 02 and Abdala were predominantly mild and transient, such as local pain at the injection site, fatigue, and headache. Serious adverse events were rare across the trials.
Real-world effectiveness data from Cuba’s national vaccination campaigns further supports these findings. A retrospective cohort study in Havana found Abdala to be highly effective in preventing severe illness and death. Estimated vaccine effectiveness against severe illness was 93.3% for partially vaccinated and 98.2% for fully vaccinated individuals. Against death, effectiveness was 94.1% for partially vaccinated and 98.7% for fully vaccinated individuals, exceeding 92.0% across all age groups. The heterologous Soberana 02 and Soberana Plus scheme also showed strong real-world effectiveness in children aged 2-11 years during the Omicron wave, with effectiveness against symptomatic COVID-19 being 75.3% in 2-year-olds and 83.5% in 3-11-year-olds.
International Reach and Recognition
Cuba’s COVID-19 vaccines have extended their reach beyond the island nation, with several countries purchasing or receiving donations:
- Vietnam purchased 900,000 doses of the three-dose Abdala vaccine and received 150,000 donated doses.
- Venezuela agreed to acquire $12 million worth of the Cuban vaccine.
- Nicaragua authorized emergency use of both Abdala and Soberana vaccines and has been receiving shipments.
- Cuba also donated 240,000 doses, including Abdala, Soberana 02, and Soberana Plus, to Syria.
The status of approval by international bodies like the World Health Organization (WHO) for Cuban vaccines has been a focus. Cuba formally submitted documentation for Abdala to the WHO for emergency use listing, and the WHO has acknowledged receipt. The evaluation process is ongoing, with Cuban officials indicating that challenges, such as payment issues due to the U.S. embargo, have caused delays in site inspections required by the WHO. While awaiting WHO validation, Cuba continues discussions with over 15 countries, primarily low-income nations, for vaccine exports. This initiative contributes to global health equity by providing accessible vaccine options, especially for developing nations with limited access to other supplies.