Abdala, the vaccine candidate, one of the five that Cuba develops against COVID-19, this Saturday was the first to conclude the third and final phase of the clinical trials, which began in March in the eastern part of the country.
The study applied in two doses by intramuscular route included 48,000 volunteers from the capitals of the Santiago de Cuba, Guantánamo and Granma provinces in order to test its efficacy.
Researchers from the Center for Genetic Engineering and Biotechnology (Cigb, in charge of developing Abdala) recently told state media that, once this stage is finished, the appearance of positive cases for the SARS-CoV-2 coronavirus begins to be evaluated.
Cigb doctor Verena Muzio explained that this will make it possible to compare the proportions between the vaccinated group and the one inoculated with placebo, and thus evaluate the efficacy.
The Center is also in charge of the intranasal vaccine candidate Mambisa, while Soberana 01, Soberana 02 and Soberana PLUS are generated by the Finlay Vaccine Institute.
Its action is based on the formulation of the recombinant RBD protein adjuvated in aluminum hydroxide, and in the second part of the trials carried out in Santiago, almost 760 volunteers between 19 and 80 years of age participated. At the moment the number of participants in the third phase has not been reported.
It will also be applied, together with “Sovereign 02”, in the massive intervention study with which the authorities intend to immunize 1.7 million people in Havana, a territory of 2.2 million inhabitants, in May.
“Soberana 02”, the other most advanced Cuban immunization project that is currently in phase III, began to be administered in the Cuban capital in 44,010 volunteers aged 19 to 80 years and will also be tested in Iran, where 100,000 doses have been sent of the formula.
None of these formulas has the authorization for emergency use or registration, so the authorities hope to achieve it in June. There are also no data available on its efficacy in the previous phases.
Cuba also develops “Soberana 01” (intramuscular) and “Mambisa” (intranasal), which are in previous stages of evaluation. If this is achieved, the Caribbean country would be the first in Latin America to have its own vaccine against COVID-19.
Cuba, which has accumulated 107,622 infections and 654 deaths to date, has been going through a third wave of infections since January with 10 of its 15 provinces and the special municipality of Isla de la Juventud in the epidemic phase.
The Cuban government has not purchased vaccines in the international market, nor is it part of the Covax Mechanism created under the auspices of the World Health Organization (WHO) to promote equitable access to immunization in low- and middle-income nations.