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Re: funciona

by Mr mua ban thuoc tay (2020-12-28)

In response to funciona

On the morning of December 17, according to the plan, the first 3 Vietnamese people will be vaccinated with Nano Covax. This is the first COVID-19 vaccine in our country to be injected into human clinical trials. Products manufactured by Nanogen Company.

These 3 people were selected from among 60 volunteers (aged 18-50) who took part in the trial in phase 1.

Dr. Nguyen Ngo Quang - Deputy Director of Department of Science, Technology and Training (Ministry of Health) - said that the Ministry of Health has set up 3 monitoring teams to support the research team. Of which, 1 is the delegation of the Ministry of Health and the Ethics Council in the national biomedical research, group 2 of the Military Medical Academy and the third is a donor hiring an independent monitoring organization.

To ensure the research process, adherence to the protocol, detect problems for the safety of the injecters, the number of studies is objective and honest. In developing new vaccines, research data is extremely important.
Responding to the risks after vaccination, Mr. Quang affirmed that the evaluation criteria in the first phase clinical trial were a safety criterion. "Volunteers are injected at the minimum dose to ensure safety. Therefore, if there are unexpected events, they can be controlled", Mr. Quang affirmed.

This phase also does not place heavy criteria on efficacy and immunogenicity such as stage 2 and 3. Therefore, after COVID-19 vaccination, volunteers must be monitored for 72 hours at the center. Military Medical Academy has ready the biological index monitoring device, connecting the surrounding hospitals. After that, the volunteer will continue to be monitored at the local residence for 56 days.

"The Ministry of Health directs, the most important thing is to protect the health of the participants" - Mr. Quang affirmed.

In the case of early access to vaccine sources in the world, Mr. Quang affirmed in principle that if the vaccine has not been approved by the US Drug Administration (FDA) and or the European Pharmaceutical Management Agency, then It is imperative to have a clinical assessment on Vietnamese. If the vaccine is approved, then consider and license the circulation immediately in the event of a pandemic outbreak.

According to Prof. Dr. Do Quyet, Director of Military Medical Academy, in order to best prepare for the trial injection, the Academy held a 3-day drill (December 14-16) before the clinical trial injection. screen on the body so that if there are any complications or side effects, the Military Medical Academy will also handle it.

"Although the rate is not high, it is still necessary to ensure absolute safety for volunteers" - Professor Quyen affirmed and said that the emergency system is always ready. People who come to inject are not because of careful preparation but fear.

Yesterday, the Ministry of Health approved the Decision on a clinical trial at Military Medical Academy. Regarding the process, the representative of the Military Medical Academy said that, after being screened and sampled, the volunteers continued to be assigned to tests, X-rays and ultrasound. After qualifying, volunteers receive an injection. The academy also prepares separate men's and women's rooms with 12 beds per room. They will rest on follow-up here for 72 hours straight after the injection.

The Ministry of Health has directed the Military Medical Academy to carefully prepare and appreciate the preparation. Dr. Nguyen Ngo Quang, Deputy Director of the Department of Science - Technology and Training (Ministry of Health), confirmed that the COVID-19 vaccine is only one part in the prevention of epidemics. People do not forget to comply with the principles of disease prevention according to the 5K Message of the Ministry of Health.

"The Ministry of Health tries to direct the early introduction of vaccines to the people, but does not see information, but neglects the prevention" - Mr. Quang said and said that in the case of early access, the vaccine could not be given immediately. 100% of the population.

With IVAC vaccine, it is expected that in 1/2021, the Ministry of Health will evaluate and then 1 month to deploy clinical trials.

Vietnam is one of the countries with vaccine research and development systems recognized by the World Health Organization.