HAVANA, Oct 21 (PL ) The Finlay Vaccine Institute of Cuba presented a second vaccine candidate against Covid-19 to the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed), it transcends today. According to the Finlay Research Director, Dagmar García, explained in her Twitter account, ‘Soberana 02 is based on the conjugate vaccine platform and the antecedent of Chem-Hib Vaccine strategy based on two candidates against Covid-19 ‘.
Quimi-Hib is the Cuban conjugated immunizer against Haemophilus influenza type b bacteria, used for the prevention of children against a said bacterial agent, which causes meningitis and pneumonia in the first years of life.
For his part, the director of the Finlay Institute, Vicente Vérez, affirmed in a recent interview with the Granma newspaper that, ‘Soberana 02 is an innovative drug, as it has no precedent among all those developed to face the new coronavirus.’
According to the expert, the novelty of this new candidate consists of being a conjugate vaccine, in which the virus antigen, the receptor-binding domain (RBD), is chemically bound to the tetanus toxoid.
Both Soberana 01 and Soberana 02, Cuban drugs in process against Covid-19 are molecular or subunit vaccines, Vérez indicated.
‘They mean that the vaccine antigen is a copy molecule of the molecule present in the virus and to obtain it, it is necessary to have the genetic information of this viral protein, and from a process of genetic engineering, it is programmed into a cell of higher body called CHO ‘, he specified.
In his statements to Granma, the manager asserted that they hope with Soberana 02 to demonstrate its safety, based on the effectiveness history of other conjugated and previously used drugs.
‘We also want to achieve a powerful and long-lasting protective immune response, as with Soberana 01,’ he said.
He also highlighted that both candidates are based on technological platforms for which there are precedents of vaccines in Cuba and in the world, whose purpose is to treat infectious diseases.
Soberana 02 completed all the required research phases in experimental animals, demonstrating a powerful and effective immune response against the virus.
After these results, Cecmed was asked for authorization to start a phase 1 clinical trial in healthy adults, and we hope to receive approval in the next few days, said Vérez.
Cuba announced on August 19 the start of clinical trials of Soberana 01, a vaccine candidate against Covid-19 made in the country, which was approved for Phase I / II studies by Cecmed.
The investigation, which began on August 24 and should conclude its stages in January 2021, is expected to be available to people by February of that year. The sample of volunteers will cover 676 people between 19 and 80 years old in all its phases.
Soberana 01 joined about 40 candidates worldwide who received authorization from the World Health Organization to advance the clinical trial in humans.