Cuba clears Abdala vaccine, first developed in Latin America to gain approval – telam

The inoculant, which has an efficacy of 92.28% according to local studies.

The Cuban regulator today authorized emergency use of the Abdala coronavirus vaccine, developed on the island and the first in Latin America to receive approval for its large-scale use.

The inoculant, which has a 92.28% efficiency according to local studies, it is already administered by CubansIt was exported to Venezuela where it will also be produced and several countries in the region have expressed interest in acquiring it, including Argentina.

The Cuban Center for State Control of Medicines, Equipment and Devices (Cecmed) decided to authorize it “once it has been confirmed that the requirements and parameters demanded in terms of quality, safety and efficacy are met, “he said in a statement.

The regulatory body explained that to give the approval, a “rigorous evaluation process” of the drug was carried out, the factories involved in its production were visited and the data obtained at different stages of the clinical trial, including the current phase 3, were studied.

In this sense, he stressed that the vaccinator “has demonstrated efficacy in the prevention of symptomatic forms of the disease of 92.28%, as well as an adequate safety profile, supported by the number of doses applied in the clinical trials carried out “.

Abdala, along with the other more advanced vaccine in Cuba called Soberana 02, is being administered massively on the island as part of a model called health intervention, with volunteers from groups at risk, such as health workers, and in territories with the highest transmission of the virus in provinces such as Havana, Santiago de Cuba or Matanzas.

According to data provided on Tuesday, about 6.8 million Cubans had received at least one dose of Abdala or Soberana 02, and 1.6 million had already received the three doses involved in the full regimen.

Cuba hopes to have its entire population vaccinated by the end of the year, becoming the first country in the world to vaccinate all of its residents with its own vaccines.“

In the case of Sovereign 02, the yield is 91.2% when two doses are combined with a third of Soberana Plus, according to the Finlay Institute, also at the origin of the world’s first vaccine against meningococcus B in 1989.

From the lab that developed these inoculants, they predicted that “in the next few days” they would send the file to the regulatory body to get the same green light Abdala got today.

Cuba expects to vaccinate 70% of its population in August and 100% before the end of the year, despite the blockade imposed by the United States which includes medical supplies, and to become the first country in the world to immunize its entire population with its own vaccines.

These two inoculants are the only phase 3 candidates developed in Latin America. and they have already aroused the interest of several countries in the region, including Argentina.

Health Minister Carla Vizzotti and Presidential Advisor Cecilia Nicolini visited Havana at the end of May.

Interest of other countries in Cuban vaccines

In this context, the Minister of Health, Carla Vizzotti, and the presidential adviser Cecilia Nicolini, went to Havana at the end of May to learn about the progress of the manufacture of vaccines.

The Venezuelan government, for its part, has already purchased 12 million doses of Abdala and announced that it will also produce it on its territory, while Vietnam and Mexico have expressed interest in adding it to their campaigns of vaccination.

In total, there are five drugs under study on the island (the others are Soberana 01 and Mambisa, in addition to Soberana Plus), plus a sixth under study with Chinese scientists, called Pan-Corona, and which aims to be the most effective next generation immunizer against the different strains of SARS-CoV-2.

Abdala’s approval comes as the country faces a sharp increase in cases, with a new 24-hour infection record recorded on Friday: 6,422 cases, including 28 deaths.

“Good news in one day with the worst national statistics of the Covid-19. A light at the end of the tunnel of this long-distance race against the pandemic,” Cuban President Miguel Daz-Canel said on his Twitter account.

In total, the island of 11.2 million people reported 224,798 positive and 1,459 deaths.

On Wednesday, authorities urgently sent doctors, equipment and medical supplies to the tourist province of Matanzas, where hospitals are overwhelmed.

Cuban television showed footage of the hospital in the town of Crdenas, 150 kilometers east of Havana, whose hallways are full of stretchers, while a local company was commissioned to manufacture new beds. , AFP news agency reported.

In this context, a citizen campaign was launched on social networks to send donations to health workers and patients in this region, and the president visited this province, accompanied by several ministers.