The COVID-19 vaccine research process in Vietnam raises many questions of public interest. Especially when the unit offered human testing.
The VTV reporter had an interview with Dr Nguyen Ngo Quang, Deputy Director of the Department of Scientific and Technological Training, Ministry of Health, Head of the Office of the National Vaccine Research and Development Program:
– Sir. So is the vaccine production technology of manufacturers in Vietnam similar to that of the world?
Dr. Ngo Tien Quang: When the epidemic hit, the health sector activated the whole system, including the scientific research system for disease prevention. Including disease prevention equipment system research and in particular COVID-19 vaccine prevention under the leadership of the Minister of Health. In March 2020, the Vietnamese vaccine research system officially started. We have surveyed, evaluated and ordered domestic manufacturers to conduct research and clinical trials on the vaccine, and developed this new vaccine for pandemic prevention.
Currently, Vietnam has 4 manufacturers who research and produce COVID-19 vaccines, including: IVAC, VABIOTECH, NANOGEN and POLIVAC with main technologies such as use of antigens, recombination of proteins … Technologies similar to those other vaccine developing countries around the world …
– Currently, the company NANOGEN has submitted a clinical trial proposal. Please tell me: What standards should vaccines be tested against?
Dr. Ngo Tien Quang: Clinical vaccine trial research is a study that requires a very high level of safety and requires a lot of investment and great effort. Therefore, before moving on to clinical research, the manufacturer must adhere to the very strict conditions of the preclinical research process, namely laboratory research and animal research. Some notable criteria such as: the results of the toxicity assessment, the safety assessment, the results of the immunogenicity assessment and in particular the assessment of the protective efficacy in animals are required. laboratory animals. These are mandatory requirements that boards should consider when deciding whether or not to allow testing on humans.
Vaccine development research is a form of research which is very risky, maybe safe, can have immunity, but a weak protective effect cannot be used in humans.
– It is known that before applying for a clinical trial license, the company NANOGEN has successfully tested in mice and monkeys with fairly good results. If the clinical trial is successful, can Vietnam mass immunize the population or not?
Dr Ngo Tien Quang: In principle, if the clinical trial is successful, it is still necessary to have the evaluation of the Ethics Council – Ministry of Health and the Vaccine Registration Council of the Ministry of Health before ” authorize the declaration of mass injection for people. We also wish to emphasize that the results of phase I, II, III trials must prove the safety, immunogenicity and especially the protective effect. These are the bases on which the Council plans to authorize the use of vaccines in humans.
– Another question, sir, how long does a human experimental study usually last?
Dr Ngo Tien Quang: A common clinical study can last from 7 to 12 years. However, in the current pandemic context, in an emergency, we have procedures that can be reduced in terms of administrative procedures, but technically and technically they cannot be reduced. After NANOGEN submitted the request for a human clinical trial, in December 2020, the Ethics Board of the Ministry of Health reviewed and evaluated and scheduled the start of the phase I research in early January 2021. It is expected that in a period of about 2 months we have a knee result to consider moving to phase 2. Phase 2 should last 4 months to get initial results and continue to phase 3. Final trial results The final clinic of the Vietnam-made COVID-19 vaccine will be available in December 2021. The Board, as I mentioned above, will then review the decision to authorize the next important steps.
