Cuba is currently improving its health protocols to fight the Covid-19 pandemic, while producing its most-advanced vaccine candidate, ¨Soberana 02¨, on a large scale, in order to begin phase III of clinical trials in March.

During the latest meeting of the temporary working group, it was insisted on the need to speed up the results of the PCR tests, as well as the corresponding transfers of positive cases to isolation centers.

At present, Cuban provinces are focused on improving active screening, increasing health controls and hospital capacities, creating new molecular biology labs, and applying restrictions on mobility.

In addition, as part of national strategy, the country is developing four vaccine candidates, of which Soberana 02 is the most advanced and is already being produced on a large scale to begin phase III of clinical trials in March.

On Saturday, BioCubaFarma Business Group President Eduardo Martínez toured the Biocen plant where a new batch of the Cuban vaccine candidate is being produced on a large scale.

During the visit, Roselyn Martinez, deputy director of Industrial Operations at the Finlay Vaccine Institute, said that production represents another milestone in the development strategy of Cuban Covid-19 vaccines.

The Cuban biopharmaceutical industry completed the first batch of 150,000 Soberana 02 doses, a scientific-technological milestone for the country, and announced that the second batch was already being produced.

According to the Pan-American Health Organization (PAHO), Cuba may become the first Latin American country to produce its own vaccine and once the candidates are concluded, it could also benefit the peoples of Latin America and the Caribbean.

(Taken from Prensa Latina)

Cuba scales up industrial production of candidate vaccines

Industrial production has begun of Cuba’s candidate vaccines Soberana 02 and Abdala (CIGB-66), two of the four developed on the island to combat COVID-19, with progress advancing at BioCubaFarma facilities

Cuba has begun the process of scaling up industrial production of Cuba’s candidate vaccines Soberana 02 and Abdala (CIGB-66), two of the four developed on the island to combat COVID-19, with progress being made at facilities affiliated with the BioCubaFarma state enterprise group.

Cuban television reported that, during in a meeting with the President of the Republic, Dr. Vicente Vérez Bencomo, director of the Finlay Vaccine Institute, stated, “We are scaling up the process of conjugation of Soberana 02, and have been able to produce a batch of 150,000 doses that came out very well, an important scientific-technical milestone.”

He reported that a second batch is already being prepared, and described the accomplishment as good news, adding that everyone involved feels “very hopeful.”

MSc Rita María García, BioCubaFarma’s director of Operations, told Granma that the first batches manufactured on this larger scale will be used shortly in phase III clinical studies of the two candidate vaccines.

Soberana 02 is an innovative product created at the Finlay Vaccine Institute, its novelty lies in the fact that it is a conjugated vaccine, in which the virus antigen, the receptor binding domain (RBD), is chemically linked to the tetanus toxoid, while Abdala was conceived at the Center for Genetic Engineering and Biotechnology (CIGB).

Cuba has extensive experience in the development and production of vaccines. At present, the national biopharmaceutical industry manufactures eight of the 11 vaccines used in the national expanded immunization program, which ensures a vaccination level in the country close to 100%, with a significant impact on the elimination of several infectious diseases and the reduction of the incidence rate of others.

(Taken from Granma)

A million doses of COVID-19 vaccines to be available in April

The director of the Finlay Vaccine Institute, Vicente Vérez Bencomo, stated that mass production of the Soberana series of candidate vaccines has begun, and Cuba can expect to have one million doses on hand in April.

He explained that the manufacturing process is underway for 100,000 doses to supply broader clinical trials of Soberana 01 and Soberana 02, and to support the needs of the country and other nations interested in the vaccine, PL reported.

Dr. Vérez indicated that Soberana 02 will begin phase III clinical studies March 1, with 42,600 volunteers. Eduardo Martínez Díaz, president of the BioCubaFarma Enterprise Group, said that the country has the capacity to supply these processes, and more will be created in the near future to guarantee the simultaneous production of Cuba’s four vaccines, the aforementioned, as well as the Genetic Engineering and Biotechnology Center’s Mambisa and Abdala.

Regarding Soberana 01, Dr. Vérez reported that findings from phase I clinical trials have been very positive, and that the plan is to begin phase II-III in March.

At the end of February, clinical trials of both candidates will begin in the pediatric population, which will include patients from five to 18 years of age. At the same time, phase I trials will be conducted with convalescent patients exhibiting low antibody titers, after having been infected and at risk for re-infection.

Regarding the advantages of this candidate vaccine, the expert noted that it would constitute an ideal immunity booster for patients recovering from a sars-cov-2 infection, and also for those vaccinated with biotechnological products.

(Taken from Prensa Latina)