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And now, Sovereign 2

The vaccine candidates from Cuba, Soberana 01 and Soberana 02 against SARS-CoV-2, are already in clinical study.

 

Danay Galletti Hernandez

 

Both are subunit vaccines, which use the viral protein as antigen and contain components that enhance the immune response  based on technology platforms validated in humans.

Developed by the Finlay Institute of Vaccine (IFV) of Havana, there is a common process for both, which is the obtaining of the viral antigen.

The most noticeable difference is that Sovereign 02 is a conjugate vaccine, in which the virus antigen is chemically bound to the tetanus toxoid, according to the website of the scientific company.

This is an innovation since there are no precedents within the 249 vaccine projects that are carried out worldwide.

Experts report that conjugate vaccines have two peculiarities: they induce long-lasting immunity and the antibodies generated protect against the disease and prevent the colonization of the oropharynx in vaccinated people.

The results of the Soberana 01 vaccine candidate are expected in January 2021 and, although no adverse reactions or serious effects are observed, the performance of the test and the processing of the samples has yet to be evaluated to check if there really are antibodies.

Therefore, the team foresees that during the first semester of that year it will be possible to start vaccinating the population.

IFV executives have reported in local media that the participants in the study of the Soberana 01 candidate, whose function is to potently stimulate the immune response, have already received both doses, after which the safety of was found to be the same and the presence of few effects verified adverse we all confirmed light.

At the same time, three other formulations of the vaccine candidate that began the Phase 1 trial have been developed, with the aim of evaluating the immune response and deciding which is the best formulation to advance to higher stages of clinical trials.

Regarding Sovereign 02, on October 27, Cecmed approved the Phase 1 clinical trial of this vaccine candidate.

“Although processes are accelerated or overlapped due to the requirement and health emergency, the stages are not violated, some of them are preclinical evaluations in animals, toxicological studies, implementation of analytical techniques to confirm that this product meets the requirements and pharmaceutical regulations for use in humans, among others, ‘Gerardo Guillén, Director of Biomedical Research at the CIGB, told Prensa latina

Scientific institutions from the Group of Biotechnology and Pharmaceutical Industries of Cuba (BioCubaFarma), the Ministry of Public Health, the University of Havana and hospitals intervene in the investigation of these vaccine candidates, where they evaluate the natural behavior of the disease and the response to treatment in patients.

One of the advantages and strengths of biotechnology and science in Cuba is there is no competition between institutions, but integration.

Everyone’s experience contributes to the faster progress of projects, they can be used for the different vaccine candidates.

In dealing with Covid-19 Cuban scientists have been helped by other experiences in complex epidemiological situations such as: dengue, bacterial meningitis and control of AIDS. (PL)

(Translated by Mónica del Pilar Uribe Marín) – Photos: Pixabay

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