Identified as FINLAY-FR-1, the vaccine project led by the Finlay Vaccine Institute, the Center for Molecular Immunology – both affiliated with BioCubaFarma – with the collaboration of the University of Havana’s Chemical and Biomolecular Synthesis Laboratory, has satisfactorily concluded the drug’s development stage and pre-clinical studies in animals, producing the scientific findings required to support authorization, by Cuba’s Center for State Control of Medications, Medical Equipment and Devices (Cecmed), to conduct clinical trials.
The announcement explained that this license allows for joint work with different institutions affiliated with the Ministry of Public Health to begin at this time, initiating “the clinical trial phase I-II, known as Sovereign, which will be followed by other clinical studies, before the vaccine is considered ready for use.”
BioCubaFarma also reported that an industrial production strategy is being developed to build capacity with the goal of “having available the millions of doses needed to protect our population,” once the studies are concluded.
Also of special interest is the fact reported that Cuba’s candidate vaccine is the 30th – the first in Latin America and the Caribbean – to receive authorization for clinical trials, among the more than 200 under development around the world.
The Finlay Vaccine Institute, which submitted the license application, has more than 30 years of experience in developing vaccines, the announcement notes, stating,
“The fact that the Institute has available platforms developed for other epidemics, specifically that developed for the meningitis epidemic in the 1980s, allowed these important results to be obtained.”
BioCubaFarma, the leading enterprise group in Cuba’s biotechnology and pharmaceutical industry, described the progress made in the urgent effort to develop a vaccine here as a tribute to Comandante en Jefe Fidel Castro Ruz, visionary founder and promoter of the sector, while taking healthy pride in the results achieved, called on the entire population to maintain rigorous implementation of preventative measures to contain the epidemic, as the country draws closer to producing our own vaccine.
“These have been weeks of intense work and self-sacrifice, very tense days, during which we have counted on the intelligence and commitment of our scientific community that has as its priority protecting health and saving lives, and assures the people that there will be no rest until every Cuban is protected from this terrible disease with a vaccine, but that, at this time, it is important to continue adhering to the hygienic-sanitary precautions established by the Ministry of Public Health to confront COVID-19.”