US-led panel exploring Cuba's solo development and deployment of COVID-19 vaccines calls for lowering barriers blocking global access to the country’s biotech innovations

First high-level delegation in five years to visit Cuba; groundbreaking Havana dialogue seeks greater role for Cuba to confront “shocking inequities” in global access to medical advances

Reports and Proceedings

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On behalf of the delegation 

US-led Panel Exploring Cuba’s Solo Development and Deployment of COVID-19 Vaccines Calls for Lowering Barriers Blocking Global Access to the Country’s Biotech Innovations 

First high-level delegation in five years to visit Cuba; groundbreaking Havana dialogue seeks greater role for Cuba to confront “shocking inequities” in global access to medical advances

Exchange also focuses on Cuba’s exceptional COVID vaccine coverage for adults and children—far greater and achieved far earlier than wealthy countries

SEATTLE (October 31, 2022) — The first U.S.-led scientific delegation to visit Cuba in five years released a consensus report today concluding that this small country’s ability to develop and rapidly immunize more than 90 percent of its citizens with safe and effective homegrown COVID-19 vaccines should serve as a model for confronting global public health emergencies in low-resource settings and the developing world.

The call for greater engagement with Cuba’s biotech sector was among the key conclusions of Cuba’s COVID-19 Vaccine Enterprise: Report from a High-Level Fact-Finding Delegation to Cuba, released today at the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH).

“What we learned about Cuba’s extraordinary COVID-19 vaccine work made it clear that it can be an important player for increasing global access to life-saving advances. And while the politics are complex, we must confront the barriers preventing its impressive brain trust of scientists and public health experts from doing so,” said Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Osterholm served as co-leader of the delegation alongside Cristina Rabadán-Diehl, PharmD, PhD, MPH, a scientist who spent 25 years leading international work at the National Institutes of Health and the U.S. Department of Health and Human Services before becoming Associate Director of Clinical Trials for Westat. The delegation (see delegation members below) was organized by MEDICC (Medical Education Cooperation with Cuba), a U.S.-based non-profit that promotes health-related dialogue and collaboration. The delegation also had members from Africa and the Caribbean and collectively brought expertise in public health systems, infectious diseases, biotechnology, and vaccine development.

The engagement was supported, in part, by a grant from the Open Society Foundations.

“The pandemic we are still fighting today has been greatly prolonged — at the cost of millions of lives and billions of dollars — by shocking inequities in access to vaccines and treatments,” Rabadán-Diehl said. “Cuba alone cannot close this gap, but it could make a much greater contribution. While there are internal challenges in areas like manufacturing capacities and publishing peer-reviewed studies, current external economic barriers on biotech and pharmaceutical products and investments are a significant limitation. They should be removed for the health of people in low- and middle-income countries in the Americas and beyond.”

The delegation’s report found that despite existing restrictions, over the last few decades Cuba has slowly developed a global network of biotech partnerships. They include a recent agreement with the Roswell Park Comprehensive Cancer Center in Buffalo, New York, to conduct clinical trials in the US on a Cuban biotech treatment for lung cancer. Delegation members cited these collaborations as a framework for wider engagement, alongside Cuba’s existing partnerships with the World Health Organization and the Pan American Health Organization. The delegation also called for greater Cuban involvement in the Coalition for Epidemic Preparedness Innovations and the World Bank’s new Financial Intermediary Fund for Pandemic Prevention, Preparedness and Response.

Lessons from Cuba’s Decision to Fly Solo on COVID-19 Vaccines

The impetus for the delegation mission was to meet directly with Cuban scientists and public health experts to learn more about an unusual moment in the COVID-19 pandemic. In mid-2020, concerned that it would not be able to procure vaccines from global suppliers, Cuba made the risky decision to go it alone and pursue a completely independent COVID-19 vaccine development program. The country’s biotech sector ended up taking two vaccine regimens through phase 3 trials and emergency use authorization. They were then distributed via Cuba’s health system to achieve one of the highest COVID-19 vaccination rates in the world — including 97 percent coverage of Cubans aged 2-18 years old, the highest pediatric coverage reported globally.

The vaccines utilize well-known technologies that allow them to be stored with conventional refrigeration, compared to the ultra-cold temperatures required for mRNA vaccines. They have received emergency use authorizations from several countries, including Mexico, Iran, Viet Nam, St. Vincent & the Grenadines, Belarus and Venezuela. Efforts are underway to secure an Emergency Use Listing from WHO.

Delegation members were especially interested in whether Cuba’s unprecedented pediatric coverage could point to a potential pathway for reducing disease transmission across all age groups. They observed that children often serve as significant vectors for accelerating the spread of infectious diseases to populations more at risk, such as the elderly. (And childhood immunization with other types of vaccines—notably pneumococcal vaccines—have been credited with significantly reducing infections for all.) The report called for an international collaboration with Cuban scientists and public health officials to assess the impact of high pediatric vaccination coverage with COVID-19 vaccines.

Delegation members also were intrigued by recent studies initiated by Cuban scientists to assess the potential of one of their COVID-19 vaccines, known as SOBERANA Plus, to be used globally as a “universal booster.” Cuban scientists are investigating whether it can effectively boost protection regardless of the initial vaccine series and also boost protection provided by prior infection — even in the unvaccinated.

The delegation report called for Cuban scientists to move more quickly to secure peer-reviewed publication of their clinical trial results. The group found that, while they understood Cuban scientists were working in challenging circumstances, a lag in publishing phase 3 results likely “delayed global access to Cuba’s COVID-19 vaccines.”

Meanwhile, delegation members noted that Cuban health professionals expressed a willingness to collaborate with other health systems to share strategies for rapidly achieving high vaccine coverage during public health emergencies — and especially in low-resource settings. The report went on to note that Cuba’s biotech capabilities could help address the growing disparity in access to health innovations to fight the rising burden of noncommunicable diseases in low- and middle-income countries.

The report explained that members were “not functioning as a regulatory review or certification body,” nor did they “seek independent verification of the data presented” on vaccine efficacy or coverage. But they cited Cuba’s previous record for developing safe, effective vaccines.

Overall, they said their goal was to engage with peers who “share a commitment to promoting scientific collaborations that seek to address the global gap in access to high-impact health innovations and interventions, a long-term disparity magnified by the pandemic.” They noted that “our delegation and our Cuban colleagues benefited from open, transparent scientific engagement, a prerequisite for the bilateral and multilateral collaboration urgently needed today to effectively prevent and address global health emergencies.”

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DELEGATION MEMBERS ISSUING THIS REPORT

Co-Leaders:

• Michael T. Osterholm PhD is Regents Professor, McKnight Presidential Endowed Chair in Public Health, and director of the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP).
• Cristina Rabadán-Diehl PharmD PhD MPH spent more than two decades at the National Institutes of Health (NIH) and also the U.S. Department of Health and Human Services (HHS), where she was Director of the Office of the Americas. She is now Associate Director for Clinical Trials at Westat.

Members:

• Joshua Anzinger PhD is a Senior Lecturer at the University of the West Indies Department of Microbiology and Consultant Virologist at the University Hospital of the West Indies, both in Kingston, Jamaica.
• Maria Elena Bottazzi PhD is Associate Dean of the National School of Tropical Medicine and Co-director of Texas Children’s Center for Vaccine Development at Baylor College of Medicine in Houston. She is co-creator of the patent-free technology behind the Corbevax COVID-19 vaccine.
• Celia Christie-Samuels MBBS DM Peds MPH FAAP FIDSA FRCP(Edin) is Professor of Paediatrics at the University of the West Indies (UWI), Mona, Jamaica and former director of their Vaccines Infectious Diseases Centre and Jamaica’s Perinatal, Paediatric and Adolescent HIV/AIDS Programme.
• Ngozi Erondu PhD MPH is an infectious disease epidemiologist who serves as Technical Director of the Global Institute for Disease Elimination (GLIDE) and provides technical support for the US Centers for Disease Control and Prevention, the World Health Organization and governments in sub-Saharan Africa, the Middle East, and Southeast Asia.
• Jeanne Marrazzo MD MPH FACP FIDSA holds the C. Glenn Cobbs Endowed Chair and is Professor of Medicine and Director of the Division of Infectious Diseases at the University of Alabama at Birmingham (UAB) Heersink School of Medicine.
• Sandra Milan Phd Bio is a Vice President, Project Team Leadership, Molecular Oncology at Genentech. She has more than 20 years of industry experience, including two years of vaccine development work and 18 years of developing oncology therapeutics.
• Peter Kojo Quashie PhD is a Senior Research Fellow at the West African Centre for Cell Biology of Infectious Pathogens (WACCBIP), University of Ghana, where his focus areas include molecular virology, antiviral therapeutics and antimicrobial drug mechanisms and resistance.
• Thomas Schwaab MD is an immunologist at Roswell Park Comprehensive Cancer Center where he serves as Chief of Strategy, Business Development and Outreach, and CEO of Global Biotechnology and Cancer Therapeutics (CBGT).
• David Williams MA MPH MDiv PhD is the Norman Professor and Chair of the Department of Social and Behavioral Sciences at the Harvard T. H. Chan School of Public Health . He is also Professor of African and African American Studies at Harvard University.