Innovation and Technology Transfer in Cuba: The Development, Production and Transfer of COVID-19 Vaccine Technology

Cuba’s success in vaccine manufacturing and technology transfer serves as a potential model for understanding the dynamics that drive innovation in vaccine technology and promote their equitable distribution.

Cuba: A Biotech Power

For many years, the Cuban government has allocated significant portions of its budget to strengthen its capacity for biotech and pharmaceutical innovation. In 2012, Cuba established BioCubaFarma, a business group that integrates 40 biotech and pharmaceutical enterprises. This umbrella agency aims to raise quality standards and improve the efficiency of facilities, equipment and human capital. 

Today, Cuba is a hub of biotech and pharmaceutical innovation and manufacturing. Both these sectors also rank as the top two technical fields for patent applications originating from the country, based on WIPO data from 2022

Role in COVID-19 Vaccine Development and Production

The country has also distinguished itself as a model for local manufacturing, licensing and technology transfer, particularly during the COVID-19 pandemic. Until August 2024, Cuba had the highest COVID-19 vaccination rate in the Latin American and Caribbean region. It also exported the vaccines it developed to several countries including Nicaragua, Venezuela and Vietnam, and entered into a technology transfer agreement with a receiving facility in Iran.

Two Cuban facilities, the Center for Genetic Engineering and Biotechnology (CGEB) and the Finlay Vaccine Institute (FVI), developed the Abdala, and Soberana (including Soberana 01, Soberana 02 and Soberana Plus) vaccines, respectively. According to the British Medical Journal (BMJ), a peer-reviewed medical journal, these vaccines have demonstrated over 90% efficacy. The CGEB also developed a second vaccine called Mambisa, the first COVID-19 vaccine for nasal administration, which has completed its clinical development as a booster dose.

Technology Transfer from Finlay Vaccine Institute to Pasteur Institute Iran

In 2021, FVI signed a technology transfer agreement with the Pasteur Institute of Iran (IPI) for the full production of the Soberana 02 and Soberana Plus vaccines. This partnership began with a team of four Cuban biotech experts being dispatched to IPI for a period of six weeks between May to June 2021.

During this period, they conducted a gap analysis to assess the facility’s needs, including design, equipment, and the delivery of Active Pharmaceutical Ingredients (APIs). Following the gap analysis, clinical trials were conducted in Iran, which led to the Emergency Use Authorization (EUA) grant as well as the continuation of technical assistance through the deployment of additional experts. The trials demonstrated the vaccine's efficacy in Iran and contributed to peer-reviewed evidence for the global scientific community.

The result was the rapid piloting of the final product, PastoCovac, in Iran, within a year. This collaboration facilitated immediate vaccine production and laid the groundwork for future vaccine development in Iran.

Following the success of the Soberana technology transfer, this partnership also extended to technology transfer for a pneumococcal vaccine. These collaborations have been instrumental in the development of the biotechnology and pharmaceutical sector in Iran, as well as in training personnel in production, quality control, quality assurance, and research and development.

Lessons Learned

Representatives from both facilities highlighted that the success of the technology transfer was rooted in a relationship of trust, with effective communication and collaborative work. Efficiency was further enhanced by the fact that the technology transfer was conducted in parallel with the commercial development of the Soberana vaccines in Cuba.

The following conditions were shared by representatives from FVI and IPI during a recent WHO-WIPO-WTO Trilateral Webinar as being key factors in a successful technology transfer:

• Operational excellence: FVI assigned experts to the IPI facility to oversee and ensure the successful completion of all stages of the technology transfer. Both the facilities followed a protocol of regular updates, which enabled clear communication and collaborative efforts. This approach helped the teams to efficiently address technical and operational challenges as they arose.
• Agile and adaptive decision making: The transfer took place in tandem with commercialization efforts in Cuba, within a “fast-track” mode. FVI provided personnel support to IPI, which helped in undertaking a comprehensive analysis of needs of the IPI facility, infrastructural improvements, training and capacity-building initiatives. This was made possible through trust, effective communication, and collaborative efforts between the facilities.
• The right partner and smart investment: Investments in drug development and related technology transfer are typically high-risk due to the complex, costly, and uncertain nature of the process, which involves rigorous testing, regulatory approvals, and potential market challenges. During pandemics, this risk is heightened as the processes are accelerated. Identifying a well-aligned partner is essential to the success of the process. The long-standing collaboration between the FVI and the IPI built confidence in the project, allowing both facilities to effectively navigate technical and operational hurdles.

A pandemic represents a major departure from standard operations, necessitating efficient crisis management and expedited processes in vaccine manufacturing. While the unique factors that accelerated COVID-19 drug development and related technology transfers are unlikely to apply to other public health concerns, there are valuable lessons to be learned. The FVI and IPI technology transfer particularly highlights the value of sustained global engagement in biotechnology and pharmaceutical manufacturing, as it fosters mutual understanding of each other's capabilities and establishes a strong foundation for coordinated responses to global health crises.

Companies can adopt forward-thinking and creative approaches to shorten development and distribution timelines and adjust their risk investment strategies. Those willing to adapt in these areas can drive lasting change, ultimately speeding up the delivery of lifesaving and life-changing drugs, diagnostics and vaccines to patients.

Blueprint for health emergencies

Cuba’s success in vaccine development and technology transfer offers valuable insights for navigating future public health challenges. Steps taken by Cuba showcase the importance of fostering trust, effective communication, and collaborative problem-solving. Such partnerships can expedite vaccine development and distribution during pandemics. While the urgency of the COVID-19 crisis may not always be present, these learnings can still inform future public health responses. By facilitating discussions and knowledge sharing among Member and stakeholders, WIPO promotes a balanced and effective global IP ecosystem that works for innovators and patients.