Cuba's regulatory authorities approved the emergency use of the anti-Covid-19 Abdala vaccine candidate for its application throughout the country, BioCubaFarma representatives announced on Twitter.
Havana, Cuba.- From the Center for Genetic Engineering and Biotechnology, the injectable showed 92.28 percent efficacy with its three-dose schedule during phase III clinical trials, a requirement that exceeds the World Health Organization's estimate (50 percent) to be declared an anti-Covid-19 vaccine.
Following the approval, the Abdala vaccine candidate became the first vaccine developed in Latin America.
The injectable met the requirements established by the island’s regulatory agency, the Center for State Control of Medicines and Medical Equipment (CECMED) per international standards in terms of preclinical studies, clinical trials, and aspects that guarantee its quality, as well as the inspection of the production process.
These requirements make possible the massive use of the immunogen (already officially as a vaccine) in the national territory and its commercialization to other nations while the sanitary emergency is maintained.
With three doses to be administered at an interval of zero, 14, and 28 days, the formulation in its trial stage included 48,290 volunteers in the eastern provinces of Santiago de Cuba, Guantanamo, and Granma and is also applied in a sanitary intervention for territories and groups at risk.
The injectable is being prepared for testing in the pediatric population in the eastern province of Camagüey.
CUBA'S PRESIDENT HIGHLIGHTS AUTHORIZATION FOR EMERGENCY USE OF ABDALA
Cuban President Miguel Díaz-Canel highlighted the authorization of the emergency use of the anti-COVID-19 Abdala vaccine, designed by the Center for Genetic Engineering and Biotechnology (CIGB).
On Twitter, the President described the event as "a light at the end of the tunnel of this long race against the pandemic and added that it was the good news of the day with the worst national statistics related to the disease."
The head of state stressed that this vaccine belongs to all those who made it possible, but also to those who put their shoulders to test it and to those immunized and those who will be immunized.
The Caribbean nation's Center for State Control of Medicines, Equipment and Medical Devices (CECMED) reported Friday on the authorization for the use of Abdala, which with efficacy of 92.28 percent became the first vaccine in Latin America against COVID-19.
To reach this point, the drug had to comply with the requirements established in the country, following international standards regarding preclinical studies, clinical trials, and aspects that guarantee the quality of the product.
With this emergency permit, the CIGB can apply to the World Health Organization (WHO) for the review process, which is carried out through the evaluation of international experts; however, each nation is sovereign to use the vaccines that have passed its approval standard.
Cuba is currently experiencing the most critical moment of the epidemic, with 6,422 cases reported on the day and 28 deaths, the highest figures since March 2020.
The number of sick people exceeds 24,000 throughout the country, while 162 patients are in intensive care wards. (RHC)
