Resumo em Inglês:

ABSTRACT Virologist Dr María Guadalupe Guzmán is recognized as a global leader in dengue research and heads the Pedro Kourí Tropical Medicine Institute’s work as a WHO/PAHO Collaborating Center for the Study of Dengue and Its Vector. The Institute (IPK) was founded in 1937 and is now Cuba’s national reference center for the diagnosis, treatment, control and prevention of communicable diseases. Dr Guzmán is also president of the Cuban Society of Microbiology and Parasitology and directs IPK’s Scientific Council, which is responsible for setting the Institute’s research priorities. A recent h-index analysis found that Dr Guzmán is among the most widely-published and cited Cuban researchers. As part of the National Intersectoral Commission for COVID-19, IPK was integral to the design of Cuba’s COVID-19 Prevention and Control Plan, approved in February 2020, more than a month before the first cases were confirmed in Cuba. This included the three-tiered biosafety training program for frontline health professionals, designed and launched at IPK, which built on the institution’s experience preparing Cuban doctors who served in West Africa with the Henry Reeve Emergency Medical Contingent during the 2014–2016 Ebola outbreak. As of this writing, the Contingent has served in 39 countries fighting COVID-19. Prior to departure, members were trained in biosafety at IPK. Today, IPK conducts COVID-19 testing and research and provides patient care. The institution is supported by an integrated national network of diagnostic laboratories, hospitals and isolation centers. In addition to research related to the clinical evolution and epidemiology of COVID-19, IPK has several studies under way on its diagnosis, pathogenesis, kinetics, immunity and genetics. In July 2020, Dr Guzmán, along with 7 other Cuban specialists, was appointed to the InterAcademy Partnership’s (IAP) COVID-19 Expert Group, a 60-member, multi-disciplinary group comprised of researchers from around the world. The group is designed to promote knowledge sharing and regional and international collaborations concerning the coronavirus using a multisector approach that takes into account the health, social and environmental factors related to the disease. This MEDICC Review interview took place in early July, a few days before the Cuban IAP appointments were announced.

Resumo em Inglês:

ABSTRACT On August 13, 2020, Cuba’s national regulatory agency, the Center for Quality Control of Medicines, Equipment and Medical Devices (CECMED), authorized clinical trials for SOBERANA 01—Cuba’s first vaccine candidate and the first from Latin America and the Caribbean. On August 24, parallel Phase I/II double blind, randomized, controlled clinical trials were launched at clinical sites in Havana to evaluate the vaccine’s safety and immunogenicity. Analysis of results and development of different formulations are currently under way and Phase III clinical trials are planned for early 2021. At the time of writing, a second vaccine candidate, SOBERANA 02, was in late-stage development and preparing to begin separate trials this fall. Cuba’s biotech industry, comprised of more than 30 research institutes and manufacturing companies in the state-owned conglomerate BioCubaFarma, has developed and distributed vaccines according to international standards of good clinical and manufacturing practices and protocols for decades. BioCubaFarma supplies over 800 products to Cuba’s national health system—349 of those are on Cuba’s Basic Drug List, the medicines approved for use in the country’s health system. Additionally, BioCubaFarma has 2438 patents registered outside Cuba and its products, including vaccines, medicines and medical equipment, are in 100 simultaneous trials at 200 clinical sites and are registered and sold in more than 50 countries. These factors proved advantageous for making a fast, confident pivot towards COVID-19 vaccine development. Specifically, these antecedents meant all necessary technical capacities and regulatory certifications were already in place. Founded in 1989, CECMED was certified as a WHO Level 4 Regulatory Authority of Reference for vaccine control (the highest certification level conferred) in 2017; also in 1989, a team at Cuba’s Finlay Vaccine Institute led by Dr Concepción Campa, developed VA-MENGOC-BC, the world’s first safe, effective vaccine against serogroup B meningococcus; and in 2000, Cuba’s recombinant hepatitis B vaccine received WHO-PAHO pre-qualification. To date, millions of people in Cuba and elsewhere have been immunized against a variety of diseases with vaccines from the island. Shortly after COVID-19 was declared a pandemic by WHO, this expertise was marshaled to develop a Cuban vaccine against the disease. Researchers from the Finlay Vaccine Institute (IFV), the Molecular Immunology Center (CIM) and the University of Havana’s Chemical and Biomolecular Synthesis Laboratory, with support from other BioCubaFarma enterprises, are leading the project aimed at delivering a safe, effective vaccine in 2021. The SOBERANA team, which is working on two vaccine candidates, SOBERANA 01 and SOBERANA 02 and several formulations thereof, is led by Dr Vicente Vérez-Bencomo, IFV Director, Dr Yury Valdés Balbín, IFV Deputy Director; and Dr Dagmar García Rivera, IFV’s Director of Research, a post she has held since 2014. A vaccine expert with a PhD in pharmaceutical sciences, Dr García Rivera is recognized for her multiple contributions to Cuban science, including development of a pneumococcal conjugate vaccine that is concluding Phase III clinical trials in preparation for introduction into the country’s national health system. She was awarded Cuba’s Annual Health Prize, the national prize of the Cuban Academy of Sciences on three occasions, and in 2019, received the Carlos J Finlay Order of Merit. Dr Garcia Rivera has represented Cuba in meetings of WHO, UNICEF and other multilateral organizations. In late September, with safety and immunogenicity trials for SOBERANA 01 continuing apace, Dr Garcia Rivera paused her feverish work schedule for this exclusive interview with MEDICC Review.