HAVANA (Reuters) – Cuba’s drug regulator granted emergency approval for its homegrown Soberana 2 vaccine on Friday, allowing the drug’s full inclusion in the country’s inoculation program as it races to curb a Delta variant-fueled coronavirus outbreak https://www.reuters.com/world/americas/coronavirus-surge-pushes-cubas-healthcare-system-brink-2021-08-11.
The Soberana vaccine, which Cuba says has an efficacy rate of 91.2 https://www.reuters.com/business/healthcare-pharmaceuticals/cuba-says-second-covid-vaccine-soberana-2-boasts-912-efficacy-2021-07-09%, has already been used to vaccinate some health workers and ordinary citizens in areas with high rates of transmission as part of early intervention studies.
Approval by the Center for State Control of Medicines, Equipment and Medical Devices means the drug, comprised of two initial shots and a booster, can be included in the national vaccine program and could also help licensing abroad.
Cuba’s healthcare system has been overwhelmed by the recent COVID-19 outbreak, struggling with a lack of oxygen https://www.reuters.com/world/americas/cuba-struggles-get-oxygen-sick-vaccines-healthy-2021-08-17, medicines https://www.reuters.com/world/americas/rare-doctors-outcry-highlights-cubas-covid-crisis-growing-dissent-2021-08-18, doctors and equipment. Just a quarter of the population of around 11 million has been fully vaccinated.
The country currently has one of the highest rates of officially confirmed cases and deaths per capita in the world, even though it managed to keep both low for much of last year.
The real numbers are likely even higher, according to reports from various provinces as the latest outbreak has outpaced its testing capacity.
Health Minister Jose Angel Portal said this week the official death toll likely fell short because it only included people who had formally tested positive for COVID-19 before death, state-run newspaper Invasor reported.
The Soberana 2 vaccine was approved last month for emergency use in Iran https://www.reuters.com/business/healthcare-pharmaceuticals/cuba-says-iran-start-producing-one-its-covid-19-vaccines-2021-07-29, which struck a deal with Cuba to produce the drug on an industrial scale in the Islamic republic.
A second locally produced COVID-19 vaccine, Abdala, which Cuba says has a 92.28 % efficacy rate https://www.reuters.com/business/healthcare-pharmaceuticals/cuba-says-abdala-vaccine-9228-effective-against-coronavirus-2021-06-21 was approved by the Cuban regulator for use last month https://www.reuters.com/world/americas/cuban-drug-regulator-gives-emergency-approval-abdala-covid-19-vaccine-2021-07-09.
Late phase clinical trial data showing efficacy rates for either vaccine has yet to be published in peer-reviewed journals.
(Reporting by Sarah Marsh and Nelson Acosta; editing by Jane Wardell)