According to the director of the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), Olga Lidia Jacobo, in addition to giving the green light for the use in emergencies of the heterologous scheme of Soberana 02 plus Soberana Plus, the entity also authorized a compound with both products for those allergic to thiomersal.
‘In that way, those patients who had not been able to be immunized against Coovid-19 due to their allergy will now have a product available for that purpose,’ he highlighted.
Two doses of Soberana 02 and one of Soberana Plus (0-28-56 days), both designed by the Finlay Vaccine Institute (IFV) demonstrated 91.2 percent efficacy during the 3rd phase of clinical trials in the prevention of Covid-19 symptoms, a requirement that exceeds the World Health Organization’s estimate (50 percent).
That was in addition to the 75.7 percent efficacy against contagion and 100 percent efficacy against severe cases and equal value in preventing deaths.
The emergency use of such proposal is issued after complying with the established national requirements, in accordance with international standards in terms of preclinical studies, clinical trials and aspects that guarantee its quality, as well as the inspection of the production process, CECMED indicated.
Such precisions make possible the massive use of both antigens (already officially as vaccines) in the national territory and their commercialization to other nations while the sanitary Covid-19 emergency is maintained.
In that regard, the director of the IFV, Vicente Verez, pointed out that the approval comes exactly 444 days after the First Secretary of the Central Committee of the Communist Party of Cuba and President of the Republic Miguel Diaz-Canel asked the local scientific community to make every effort to develop its own vaccines.
Verez highlighted that both Soberana 02 and Soberana Plus are used in the clinical trial of Soberana-Pediatrics that is taking place in Havana with 350 volunteers from three to 18 years old, which already shows very encouraging results.
‘With two doses of Soberana 02, designed by the IFV, children aged 12 to 18, are raising antibodies at the level of three doses in adults (heterologous scheme of two injections of Soberana 02 plus one of Soberana Plus, also from Finlay),’ the expert revealed.
CECMED emphasized on its official Twitter account that so far, Cuba already has three vaccines against Covid-19 of its own.
Soberana 02 and Soberana Plus, are added to the Abdala vaccine, designed at the Center for Genetic Engineering and Biotechnology, which received authorization for use in emergencies since July 9, 2021.