Since November last year, a group of researchers from the Catholic University is developing a Phase 3 clinical study with Coronavac, the vaccine against the Sars-CoV-2 virus, the cause of the pandemic the world is experiencing today
Today in the afternoon, the first results of the study in which 2,000 healthy people participated were delivered to the authorities of the Ministry of Health and the Ministry of Science, data related to the quality, immunogenicity and safety of this vaccine.
The academic of the Catholic University Y director of the Millennium Institute in Immunology and Immunotherapy, Alexis Kalergis and director of the clinical trial highlighted the importance of carrying out this study, since when applied to the national population, it provides, from the first source, information on the safety of the vaccine and the induction of immunity in our population.
Infectóloga Katia Abarca, Clinical director of the study, noted that in terms of safety of the participants, very few adverse effects were recorded in frequency and all of them mild. The one that was repeated the most was pain in the area that passed in one or two days, less than 5% of people had a low fever, others indicated other mild discomfort and no serious adverse events were recorded, so the vaccine “has a very good safety profile ”.
Overall, the study evaluated the immune response in a subset of the volunteers who received the vaccine or placebo. The results indicate that 14 days after the first dose, an increase in antibodies against SARS-CoV-2 protein S, the protein that binds to the cell to invade, is observed in only a fraction of those vaccinated. However, two weeks after the second dose, the presence of antibodies was observed in 90% of those vaccinated.
Furthermore, it is observed that these antibodies present after the second dose have neutralizing capacity, that is, they would prevent the entry of the virus into human cells.
Susan Bueno, scientific director of the project, He said that the vaccine was shown to induce antibodies that increase significantly after the second week of the second dose, and are antibodies with neutralizing capacity. With the first dose, a little less than 50% of those vaccinated, made antibodies.
Another aspect that the researcher highlighted is that the vaccine is not only directed against a protein of the virus, since when inoculating the complete but inactive virus, the immune system generates antibodies against other cells of the virus.
Regarding differences in the immunity generated between those over 60 years of age and those under that age, Bueno said that there were no variations. There were also no differences between men and women.
At the results delivery ceremony, held at the headquarters of the Catholic University, the Minister of Health, Enrique Paris; the undersecretary of this portfolio, Paula Daza; the Minister of Science, Technology, Knowledge and Innovation, Andrés Couve and the Rector of the UC, Ignacio Sánchez.
In the study led by the Catholic UniversityThe Scientific Consortium to Evaluate COVID-19 Vaccines also participated, with centers such as the Sótero del Rio Hospital, San Carlos de Apoquindo Clinic, Gustavo Fricke Hospital and German Clinic, U. Andes Clinic, Hospital Félix Bulnes together with the Universidad San Sebastián and the Universidad de Antofagasta.
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