Cuba's National Regulatory Authority & COVID-19: Olga Lidia Jacobo-Casanueva MS Director, Center for State Control of Medicines and Medical Devices (CECMED).

At the time of this writing, more than 10 million Cubans (nearly 90% of the country's population), had received at least their first dose of Soberana 02 or Abdala, two of five vaccine candidates for SARS-CoV-2 developed and produced on the island. Late-phase clinical trial data revealed that Abdala is 92.28% effective after the full, three-dose cycle and Soberana 02 is 91.2% effective after two doses, when followed by a booster of Soberana Plus.[1] Cuban health authorities have committed to vaccinating the entire population, including children aged 3-18 years old, using these vaccines by the end of 2021. The first pre-clinical, peer-reviewed data are available,[2] with clinical trial results already submitted to various international journals. Building on decades of biotechnology know-how developing, producing and administering 11 preventive vaccines for childhood diseases-used in the nation's universal health system and also marketed elsewhere-Cuba is the first, and to date only, country in Latin America and the Caribbean to develop its own vaccine candidates for COVID-19 (Soberana 01; Soberana 02; Soberana Plus; Abdala and Mambisa; see Box on following page). In a strategy designed to ensure comprehensive and importantly, independent solutions to the global health crisis, research institutes and manufacturing facilities coordinated by BioCubaFarma-the country's biopharmaceutical conglomerate-have also developed COVID-19 treatments and essential medical equipment. To gain a better understanding of the regulatory process involved, MEDICC Review turned to Olga Lidia Jacobo-Casanueva, Director of the Center for State Control of Medicines and Medical Devices (CECMED), Cuba's national regulatory authority (NRA). A clinical microbiologist, Jacobo-Casanueva served as interim director throughout 2020 before becoming director in January 2021. She has spent nearly her entire career at CECMED, working her way up the ranks in a unique trajectory: from her first position in 1992 in the Center's microbiology laboratories, she has since worked in all but one of the six areas required by WHO to qualify as a National Regulatory Authority of Reference (NRAr; CECMED was certified as a Level 4 NRAr in 2011, a qualification it maintains). In short, Jacobo-Casanueva is a regulatory polymath, with hands-on experience in nearly every facet of regulation. She is also an adjunct researcher in the Faculty of Biology at the University of Havana. Cuba's decision to confront the pandemic autonomously by developing preventive vaccines to control COVID-19 is deliberate and fraught with challenges. With dozens of ongoing clinical trials, coupled with the declining epidemiological and economic situation in Cuba-exacerbated by tightened US sanctions affecting all facets of COVID-19 prevention and response-we appreciate the time Jacobo-Casanueva took from her schedule to parse the complex regulatory mechanisms required to introduce Cuban and imported products into the national health system. Editor's note: Just days after this interview was conducted in Havana, CECMED granted Emergency Use Authorization for Abdala, one of five Cuban COVID-19 vaccine candidates undergoing clinical trials since 2020.

Microbiota intestinal y su relación con agentes oportunistas vinculados a las epidemias / Gut microbiota and its relationship with opportunistic agents linked to epidemics

Resumen Existen epidemias silenciosas asociadas al estrés y a los malos hábitos de alimentación, tan importantes como las epidemias tradicionales asociadas a la pobreza, a problemas geográficos y climáticos. Numerosos estudios se suman al importante papel de un patrón estable de la microbiota intestinal que favorece el estado saludable en los seres humanos y por lo tanto, su posible implicación en la incidencia y prevalencia de enfermedades que pueden convertirse en epidémicas. En esta revisión se analiza el estado actual de la relación entre los factores demográficos, geográficos, ambientales, patrones de consumo de alimentos con la microbiota intestinal y la aparición de epidemias de origen microbiano, metabólico e inmunológico. Se apoya la iniciativa promovida internacionalmente para la creación de plataformas metagenómicas que contribuyan al estudio del patrón de la microbiota intestinal, el seguimiento epidemiológico y la prevención de las enfermedades epidémicas asociadas con su alteración, así como el diseño de métodos rápidos y económicos para la complementación de estos estudios.

Abstract Silent epidemics associated with stress and unhealthy eating habits are as important as traditional epidemics related to poverty, geographical and climate problems. Many studies incorporate the important role of a stable pattern of gut microbiota that favours the human health status and therefore, its possible implication in incidence and prevalence of diseases that can become epidemics. In this review, the current state-of-art is analysed in terms of relationship between demographic, geographic, environmental factors, and habits with the gut microbiota pattern and the onset of epidemics of microbial, metabolic and immunological origin. The internationally promoted initiative for the creation of metagenomic platforms contributing to studies of the gut microbiota pattern for the epidemiological monitoring and prevention of epidemic diseases associated with its alteration is fostered, as well as the design of rapid and economic methods to complement these studies.

Resumo Existem epidemias silenciosas associadas ao estresse, maus hábitos alimentares, tão importantes quanto as epidemias tradicionais associadas à pobreza, problemas geográficos e climáticos. Numerosos estudos contribuem para o importante papel de um padrão estável de microbiota intestinal que favorece o estado saudável em seres humanos e, portanto, sua possível comprometimento na incidência e prevalência de doenças que podem se tornar epidêmicas. Esta revisão analisa o estado atual da relação entre fatores demográficos, geográficos, ambientais, padrões de consumo de alimentos com a microbiota intestinal e o aparecimento de epidemias de origem microbiana, metabólica e imunológica. É fornecido apoio à iniciativa promovida internacionalmente para a criação de plataformas metagenômicas que contribuam para o estudo do padrão da microbiota intestinal, monitoramento epidemiológico e prevenção de doenças epidêmicas associadas à sua alteração, bem como o desenho de métodos rápidos e baratos para a complementação desses estudos.