Chairman of the National Ethics Council in Biomedical Research said that in phase 3, the subjects of Vietnam’s COVID-19 vaccine trial will be more open, such as workers in industrial zones.
Illustration GS. Dr. Truong Viet Dung, Chairman of the National Ethics Council in Biomedical Research, said in the SK & DS newspaper, in phase 3, the subjects of the Nano Covax vaccine trial in Vietnam will expand. The object here means the area, which can be extended to other areas such as workers in industrial zones. However, areas or industrial zones with COVID-19 cases were not selected for clinical trials because it would be interpreted as the epidemic situation that made people too worried and accepted to participate in the research. Therefore, research can only be carried out in industrial zones at risk of disease outbreaks, not in industrial zones with epidemics. Testing participants for COVID-19 to confirm the absence of antibodies is required. In the spirit of “testing as quickly as possible” of the Government, the Ministry of Health assigned testing units. Fast does not mean cutting, skipping stages. Any stage must comply with international requirements and standards. Do it very quickly but must be very standard, giving it to the Council must be approved immediately. In general, in accordance with the process and step by step of each phase, so that the Ministry of Health has enough scientific basis to be able to grant urgent and conditional use of Nano Covax vaccine in Vietnam. Information on Vietnam plus, Deputy Director of Military Medical Research Institute Ho Anh Son said that according to the latest information, it is possible that as soon as next week (expected in early June 2021) will enter vaccine research. Nano Covax phase 3 with the expected number of volunteers to participate is about 13,000 people. In phase 3, the implementation is very fast, following the correct process, and at the same time meeting the needs of disease control in Vietnam. Up to now, the Military Medical Academy has mobilized a lot of doctors, technicians, students… to participate in the testing process so that it can be ready for deployment in 10 provinces/cities across the country at the same time. country. After testing phase 1 and phase 2, Nano Covax vaccine is quite safe, so the criteria for recruiting volunteers will be relaxed more than the previous 2 phases. Volunteers participating in phase 3 from 18-75 years old, only need to check the blood count and check for antibodies to the SARS-CoV-2 virus. People who have been exposed to the SARS-CoV-2 virus or already have antibodies will be excluded from the test population. More about the phase 3 trial, Lieutenant General, Professor-Dr. Do Quyet, Director of the Military Medical Academy, Ministry of National Defense said that he believes in the safety of the Nano Covax vaccine with the results achieved. through the previous two phases of testing. According to the Director of the Military Medical Academy, immunogenicity is reflected in two main factors: antibody concentration and antibody immunogenicity. Specifically, the concentration of SARS-CoV-2 virus antibodies after injection of the phase 2 trial showed a very high increase in antibody titres, from tens to hundreds of times. Antibody immunogenicity to assess the ability to neutralize SARS-CoV-2 virus living at the 35th day of good response, above the prescribed threshold. As for the ability to neutralize the virus at day 42, the team has now evaluated 22/110 samples; expected to be completed in early June 2021 to report to the National Ethics Council in Biomedical Research. Phase 3 aims to evaluate the protective effect of the vaccine on the community, designed in many centers, expanding to other localities with a larger number of samples with only 1 injection. Based on the results of the evaluation, the National Ethical Council in Biomedical Research selected the experimental injection of 25mcg dose. Strictly following international guidelines, the National Ethical Council for Biomedical Research also identified a phase 3 trial in 10,000 people. Military Medical Academy complies with the approved outline and deploys to recruit volunteers.
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