Havana, November 2 (Latin Press) The Center for Biotechnology and Genetic Engineering of Cuba (CIGB) delivered the documentation to evaluate its first vaccine candidate against Covid-19 and, after its analysis, it was approved by the regulating authority.
In our case, we study a protein of the hepatitis B virus, which we produce by means of recombinant genetic engineering in bacteria and yeasts in the form of particles and whose properties also boost the immune system,’ Dr. Gerardo Guillén, Director of Biomedical Research of the CIGB, stated to Prensa Latina.
Unlike other projects, they focused on immunization through the nasal route since this virus is respiratory and infects, precisely, through the nasopharynx mucosa, he expressed.
According to Guillén, the immunization through the nasal route favors the development of a local response, whose objective is to prevent not only the disease, but also the colonization and transmission of the virus.
There are many asymptomatic people, both in the initial stages of the disease and in the course of it, and even if they recover clinically, they continue as carriers of the virus.
The expert commented that the Cuban regulating authority has analyzed, practically in parallel, the projects and proposals in order not to delay their approval, and he assured that the accompaniment has been from the initial stages and the specialists examine each one of the results, which makes the process more expedite.
Both the Finlay Institute of Vaccines (IFV) and the CIGB, the Cuban institutions that develop vaccinal candidates against SARS-CoV-2, use the platform of vaccines by subunits, so it is known the pharmaceutical forms based on specific proteins obtained from biotechnological ways.
The platform by subunits is, maybe, the one that takes more time to provide a vaccinal candidate, but it has the advantage of safety, because it is not worked with a virus or with a complex mixture where there can be toxic compounds or which generate unexpected effects in the organism,’ he explained.
Likewise, he warned that the process is performed with high purity proteins and with a known sequence, specifically, the viral protein. This technology allows manipulating and presenting the antigen in the most appropriate way to favor and induce the immune response,’ he argued.
Both scientific centers develop candidates based on already existing platforms.
The experts of the Finlay Institute are investigating the vesicle of the external membrane of Neisseria meningitidis, which is the base of the antimeningococcal vaccine, one of the leading products of Cuban biotechnology since the 80s of last century. This immunopotentiation platform is used in the production of different vaccines in the country.
Integration of scientific institutions
Cuba’s vaccine candidates, Soberana 01 and Soberana 02 against SARS-CoV-2, are already under clinical study. Both are subunit vaccines, using viral protein as antigen, containing components that improve the immune response and based on technological platforms validated in human beings.
Developed by the IFV of Havana, there is a common process for both of them, which is the obtention of the viral antigen and the most perceptible difference resides in the fact that the Sovereign 02 is a conjugated vaccine, in which the virus antigen is chemically linked to the tetanus toxoid, according to the page of the scientific institution.
The latter constitutes an innovation since there are no precedents within the 249 projects of vaccines that are executed worldwide. The experts inform that the conjugated vaccines have two peculiarities: they induce long lasting immunity and the antibodies generated protect from the disease and prevent the colonization of the oropharynx of the vaccinated persons.
The results of the Sovereign 01 vaccine candidate are expected for January 2021 and, although no adverse reactions or serious effects are observed, the behavior of the assay and the processing of the samples have yet to be evaluated, to check if there are really antibodies. Therefore, the work team foresees that during the first semester of that year it will be possible to start vaccinating the population.
IFV directors have informed in local media that the participants in the study of the Sovereign 01 candidate, whose function is to potently stimulate the immune response, already received the two doses, after which it was proved the safety of it and the presence of few adverse effects, all of them light.
At the same time, they develop three other formulations of the vaccine candidate that started the Phase 1 trial, with the objective of evaluating the immune response and deciding which is the best formulation to advance to higher stages of clinical trials. Regarding Sovereign 02, last October 27th, Cecmed approved the Phase 1 clinical trial of that vaccine candidate.
Although the processes are accelerated or overlapped due to the demand and health emergency, the stages are not violated, some of them are the preclinical evaluations in animals, toxicological studies, implementation of analytical techniques to confirm that this product complies with the requirements and pharmaceutical regulations for its use in humans, among others,’ Guillén said.
Scientific institutions from the Group of Biotechnological and Pharmaceutical Industries of Cuba (BioCubaFarma), the Ministry of Public Health, the University of Havana and hospitals take part in the research of these vaccination candidates, where the natural behavior of the disease and the response to the treatment in patients are evaluated.
One of the advantages and strengths of biotechnology and science in the country is that there is no competition among the institutions, but integration. Everyone’s experience contributes to the faster progress of the projects; in turn, the analytical techniques and biological materials can be used for the different vaccine candidates,’ Gerardo Guillén said.
He also referred to the beginning and progress of the biopharmaceutical industry in the Greater Antilles, whose promoter was the leader of the Revolution, Fidel Castro. In the confrontation with Covid-19 other experiences have helped us in complex epidemiological situations such as: dengue, meningitis of bacterial origin and the control of AIDS’.
Evolution of treatment against the pandemic
Since the outbreak of the epidemic in China, Cuban scientists have participated in an intense process of debate to redirect existing medicines to combat Covid-19. That is why one of the objectives was to guarantee the production of interferon alpha-2b-recombinant.
Today we have another product which is Heberferon, a combination of interferon alpha-2b and interferon gamma. This is a product registered since 2012 for the treatment of non-melanoma skin cancer. It is known that these interferons have antiviral and immunoregulatory properties, that is to say, they also boost the immunological and anti-inflammatory response,’ the Cuban expert referred.(Taken from PL)
After a study in Luis Díaz Soto Hospital in Havana, in which the Interferon alpha and the Heberferon were compared, the result evidenced that there was a negativization or elimination of the virus more quickly when the sick person was treated with the combination. It also demonstrated that the patient was discharged earlier.
This is how the group of experts BioCubaFarma- MINSAP decided to modify the National Protocol for the treatment of patients with Covid-19. Heberferon was introduced instead of Interferon alpha-2b and it was decided to perform the PCR diagnostic test on the ninth day instead of the 14th day, which contributes to a shorter hospital stay, a decrease in active cases and savings in resources. We also carried out the study with the Jusvinza peptide for rheumatoid arthritis. We have been working with this peptide for several years. It is totally new and regulates the immune system in order to reduce the state of hyperinflation, which marks the severity of the patients’ evolution. It is a very safe product, with few adverse reactions, and we have extensive knowledge about its mechanism of action,’ the specialist detailed.
In the period of one month, during the application to serious and critical patients, there were no cases of mortality in the Luis Díaz Soto Hospital. The peptide was also included in the treatment protocol in the intensive care units. To date, more than 190 patients have received the medication, with more than 85 percent survival.
The innovation group also proposed as a new category of patient stratification: ‘moderate high-risk’. It is a previous step to intensive therapy and it is applied to patients over 65 years old, with comorbidities and who have diagnostic signs of inflammation.
The purpose is to give a direct follow-up to the patients and prevent them from becoming serious, with the administration of Jusvinza and the monoclonal antibody Itolizumab, developed by the Center of Molecular Immunology. Besides, others are included such as: Biomodulin T, from the Biopreparations Center and the transference factor from the CIGB, used in vulnerable groups of the population.
The CIGB’s Nasalferon, a formulation of Interferon nose drops, is also provided to Henry Reeve Brigade health professionals before serving in other nations, to medical personnel in the red areas, and to vulnerable groups. Likewise, other clinical studies are being conducted with antivirals to boost innate immunity, the body’s first defense,’ Dr. Guillén concluded.
(Taken from PL)