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Phase III trials are scheduled to start on March 1st, after the injectable vaccine showed in its study stages II A and II B high levels of safety and a strong immune response.
Cuba Soberana 02's vaccine candidate against COVID-19 should begin its Phase III clinical trials on March 1, the director of the Finlay Institute, Vicente Vérez, announced here today.
During a virtual appearance at the headquarters of the Pan American Health Organization on the island, in this capital, Vérez emphasized that this date is foreseen because the injectable showed in its study stages II A and II B high levels of safety, as well as a powerful immune response.
"It also induces long-lasting memory of that immune response which, in addition to producing antibodies, makes them last," the expert pointed out.
He explained that Phase III clinical trials will have around 150,000 doses for inoculation of volunteers.
He also pointed out that with this product, the use of a third dose with a reinforcement action is being considered in order to induce an immune response of viral neutralization.
Soberana 02 began the second period of clinical trials last December 22 and thus became the first Latin American candidate to reach this stage, which includes almost 900 volunteers.
It is a conjugated vaccine, in which the virus antigen, the receptor binding domain (RBD), is chemically linked to the tetanus toxoid, has two formulations and the second one achieved great effectiveness in animals.
Cuba is currently working on the creation of capacities to produce 100 million doses of Soberana 02 in order to meet the needs of the country and also of other nations interested in the injectable.
Prospects for #Cuban#COVID19 vaccines: Phase 3 trial for Soberana 02 vaccine slated for March. Vacunas cubanas pueden contribuir a enfrentar covid en América Latina https://t.co/dqsd6TSjDo
Recently, in a meeting with foreign press agencies accredited in the country, Vérez stressed that the strategy to commercialize it has a combination of humanity and impact on world health.
He clarified that all foreigners who arrive in the country and want to be vaccinated with Cuban candidates will be able to do so.
"We are not a multinational where the financial purpose is the number one reason, our purpose is to create more health," he assured.
The Finlay Vaccine Institute, leader of this project, also developed the Soberana 01 candidate.
The Caribbean island, the first in Latin America to present its own vaccines against COVID-19, also has two other proposals developed at the Center for Genetic Engineering and Biotechnology: Abdala and Mambisa.
For his part, the president of the Business Group of Biotechnological and Pharmaceutical Industries, Eduardo Martinez, declared that given the positive effects of the Cuban candidates, the emergency use of some of them could begin in March.