Presented by Cuba’s State Control Center for Drugs, Equipment and Medical Devices (CECMED) this Friday Emergency Application Approval for the Cuban Vaccine against the Corona Virus Abdala, Showed 92.2% efficacy in its clinical trials.
Authorized “Once it is confirmed that the required requirements and parameters are met based on the quality, safety and performance of this type of procedureCECMED said in a statement.
One of the five formulas developed by the Caribbean nation against COVID-19, the aptala and the first to reach the vaccine type, Is a subunit immunogen with a three-dose intramuscular administration schedule at 28 days It was developed by the state-owned Center for Genetic Engineering and Biotechnology.
Once you get the green light for your emergency use, Abdala is officially recognized as a vaccine by the vaccine candidate, It does The first type created in Latin America.
The regulatory authority’s note is a “Strict evaluation process of the submitted file”, Which includes studies of plants involved in the production process.
Decided to start “Phase I and Phase II clinical trials (already completed) and Phase III clinical trials (active), Which is shown as one 92.28% Efficacy in preventing symptomatic forms of the disease, As well as adequate security profile ”.
According to CECMED, the above was supported by “the number of doses used in the clinical trials carried out, the intervention in the risk population study and the health intervention carried out in our country”.
The Abdala vaccine is already being given to tens of thousands of people in high-risk areas in Cuba for several weeks, under the aforementioned population interventions and in parallel with clinical trials.
Following the approval for the urgent use of this vaccine, CECMED is expected to soon issue it to the more advanced Cuban candidate Soberana 02 from Finlay Vaccine Company (IFV).
Soperana 02 is 91.2% effective, local health officials announced Thursday According to preliminary analyzes of the third phase trials, in the two-dose program combined with one-third of the Sovereign Plus formula.
Having an emergency use permit would allow Cuba to vaccinate large numbers of its population, Which experiences the devastation of the third and worst epidemics since the onset of the epidemic.
The country recorded 6,422 new positives and 28 deaths this Friday, compared to 224,798 cases and 1,459 deaths since March last year, according to the Ministry of Public Health.
Cuba does not integrate the World Health Organization’s Kovacs mechanism, which was developed to access vaccines to low- and middle-income countries, and does not purchase them on the international market.
(With information from EFE)