Globe, Latin America, United Kingdom

Soberana 01, safe and aiming for success

Cuba had the raw materials to do it: the evolution of the biopharmaceutical industry and unity among the research centres, guarantees the realisation of a vaccine against the new coronavirus SARS-CoV-2.

 

Elizabeth Borrego Rodríguez

 

On 13 August it was registered with the Cuban Public Register of Clinical Trials and is currently presented as a project in phase I/II “randomised, controlled, adaptive and multicentric to evaluate safety, reactogenicity of immunogenicity of the prophylactic candidate vaccine”.

At the end of the same month, the presentation of Soberana 01 stunned the world and after more than two months of advances, its creators are confident of the safety of the project. At the beginning of September, the study was included on the New York Times Coronavirus Vaccine Tracker, an interactive tool with those candidate vaccines in human trials and other advanced projects in cells or animals.

According to this gauge, 46 vaccines are being tested on humans on an international level, and at least 91 preclinical studies are in active research on animals.

The project, known officially as FINLAY FR-1, plans to conclude its test phases in February 2021 as a feasible alternative to stop the spread of the virus.

If all the testing phases are completed and its safety and efficiency is demonstrated, it could be the first vaccine against the new coronavirus developed in Latin America.

Tammy Boggiano, Director of Development at the Centre of Molecular Immunology (CIM) and one of the research leaders, has recognised the island’s independence in biotechnology as a strength.

Boggiano said to the press that the platform on which the vaccine is being developed is very safe, as it is based on the VA-MENGOC-BC, given to children for active immunisation against meningococcal disease.

In this case, a specific SARS-CoV-2 protein was added so that the immune system reacts and boosts antibodies, a complex molecule that was the CIM’s contribution to the development of the candidate, she explained.

“If the vaccine is anything, it is safe. This takes time to demonstrate, but I am confident that it is going to be, above all, successful”, she said.

The initiative was presented by specialists at the Finlay Vaccine Institute (IFV) and the CIM at the end of August and it began to be applied on 24 August to people without clinically significant alterations who gave their written consent to participate.

In the first phase it was administered to 20 people between 19 and 59 years old and, a week later, another 20 received it, with ages ranging from 60 to 80 years.

In September the number of volunteers increased until there were 676 tests.

According to press reports, in the first phase participants received the injection in two of its variants, a lower dose and a higher dose, or the control product: the VA-MENGOC-BC, one of the IFV’s leading items.

On 18 October the Cuban Public Register of Clinical Trials included a new prophylactic candidate vaccine against Covid-19, officially called FINLAY-FR-1A, or Soberana 01A.

This second project against the pandemic began its development phase on 19 October and will finish this on 9 November. It will be carried out in parallel with the first trial, according to the Register’s web portal.

According to Boggiano, the immunisation of the population against Covid-19 constitutes one of the fundamental challenges of current science, which is why Cuba is joining these efforts even without the financial resources that other international companies have. (PL)

(Translated by Donna Davison – Email: donna_davison@hotmail.com) – Photos: Pixabay

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