Cuba begins clinical trials of a COVID-19 vaccine

Cuba has begun clinical trials of a potential coronavirus vaccine known as Soberana 01.

Granma, the official voice of Cuba’s Communist Party, reported in late August that the country’s overall biotech and pharmamanagement group BioCubaFarma has received permission from the country’s regulatory authorities to begin clinical trials of the candidate vaccine. The group said that it was ‘capable of producing a strong immune reaction to a SARS-COV-2 infection’ (COVID-19).

BioCubaFarma separately 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.

BioCubaFarma said that, working together, Cuban institutes and universities had ‘satisfactorily concluded the drug’s development stage and pre-clinical studies on animals, producing the scientific findings required to support authorisation, by Cuba’s Centre for State Control of Medications, Medical Equipment and Devices (Cecmed), to conduct clinical trials’.

Initially identified as FINLAY-FR-1, the vaccine project is being led by the Finlay Vaccine Institute and the Centre for Molecular Immunology working with the University of Havana’s Chemical and Biomolecular Synthesis Laboratory. The clinical trial phases will be followed by other clinical studies before the vaccine is considered ready for use.

The official announcement indicated that the Finlay Institute had gained invaluable experience from having accumulated research over thirty years in other epidemics, and specifically in the meningitis epidemic in the 1980s.

Soberana 01 has reportedly already been tested on the three Cuban scientists who developed the candidate vaccine. All reportedly developed ‘a high immune response’ which was confirmed after a second dose was applied.

Cuba’s candidate vaccine is the thirtieth internationally, and the first in Latin America and the Caribbean, to receive authorisation for clinical trials among the more than 200 under development globally.

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