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On the evening of November 2, the leaders of the Department of Science, Technology and Training (Ministry of Health) and the leading Vietnamese experts in the field of vaccine testing, research and testing had a meeting at the University. Military Medical Institute (Ministry of Defense) in the preparation of the first phase of the Covid-19 vaccine trial investigated by Vietnam.
Accordingly, the first unit vaccine being considered and approved by the Ministry of Health in the phase 1 clinical trial (human trial) is a Covid-19 vaccine from Biotechnology Joint Stock Company. Nanogen Pharmacy Study (High-Tech Park, District 9, Ho Chi Minh City) for research and development.
At the meeting, Dr. Nguyen Ngo Quang, Director of the Department of Science, Technology and Training (Ministry of Health), said that the Ministry of Health provides the highest and most favorable support for the evaluation and approval of vaccine tests. -xin Covid-19 will be implemented at the earliest, expected in November. However, Mr. Quang also requested that this study must strictly comply with regulations to ensure the safety of volunteers participating in the Covid-19 vaccine trial. The clinical research units during the implementation period must strictly comply with the regulations of the Ministry of Health on technical and ethical factors in research.
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The stage 1 clinical trial vaccine is known to be the next stage after the safety and immunogenicity of the vaccine has been evaluated in animals. The clinical research facility must be evaluated by the Ministry of Health to meet the standards of facilities, equipment and human resources, not only helping to evaluate the effectiveness of vaccines after injection in volunteers, but also before All, ensure the safety of volunteers.
As the vaccine manufacturer suggested, in the phase 1 clinical trial, the Covid-19 vaccine will inject more than 60 volunteers. Recently, the Covid-19 vaccine has been produced on a laboratory scale, testing to evaluate safety and immunogenicity in animals (mice, monkeys).
According to the Nanogen Pharmaceutical Biotechnology Joint Stock Company report, so far the unit has successfully investigated and produced 4 antibodies based on the sequence of 4 antibodies isolated from Covid-19 patients. re-enable. Previously, the unit sent the sample to the Central Institute for Drug Quality Control to assess its safety. Initially, the results of the unit’s viral neutralization tests were satisfactory.
The company said that if all procedures were completed and approved, based on available technology, it could produce about 20 million doses of vaccine per month.
The Health Ministry said that Vietnam currently has 4 domestic manufacturers that are in the process of research and development of Covid-19 vaccines, initially showing positive results. In addition to the previous unit, the Institute for Vaccines and Medical Biological Products (IVAC) is expected to have a batch of clinical trials by the end of this year.
Vietnamese companies strive in the race to produce vaccines- Photo: D. Nguyen
At the same time, Vaccine and Biological Products One Member Limited Company (VABIOTECH) began preclinical testing of the Covid-19 vaccine in a second animal, a monkey. This unit was tested simultaneously in monkeys and mice. After the injection is complete, the monkey is expected to be monitored for about 3 months, then continue to take blood samples and send them to Hanoi for analysis.
Previously, this agency tested the Covid-19 vaccine in mice. And the tests on these two animals were done in parallel to get enough data. If VABIOTECH Company accelerates progress faster, it will not be early 2021 to have a batch of vaccines for clinical trials.
Experts believe that if there are favorable conditions and good and satisfactory results in the laboratory, it will not be until mid-2022 that Vietnam will have the Covid-19 vaccine.
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