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

ABSTRACT

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.