Illustration. At the meeting of the National Steering Committee for COVID-19 prevention and control on the afternoon of June 11, Deputy Minister of Health Tran Van Thuan informed that the Ministry of Health had officially approved the phase 3 clinical trial of the vaccine. Vietnam’s first COVID-19 room named Nano Covax. According to Deputy Minister Tran Van Thuan, the Ministry of Health has just approved the phase 3 clinical trial of Nano Covax vaccine of Nanogen Company. According to Lieutenant Colonel, Assoc. Dr. Chu Van Men – Director of the Center for Clinical Trials and Bioequivalence, Military Medical Academy, Ministry of National Defense, phase 3 injected the Nano Covax vaccine to 13,000 people and injected only a single dose group. 25 mcg and placebo injection group (with a ratio of “6 people vaccinated to 1 person injecting placebo” according to the design approved by the Ministry of Health). As for the reason for choosing the 25 mcg dose group, Assoc. Prof. Dr. Chu Van Men said that when the phase 2 trial showed that, the 3 dose levels of 25-50-75 mcg had equivalent safety and immunogenicity. undifferentiated. Therefore, in order to ensure the safety and increase the effectiveness of the number of doses of vaccine production, the National Ethical Council in Biomedical Research, the Ministry of Health decided to inject only 1 optimal dose of 25 mcg at the initial stage. this. Minister of Health Nguyen Thanh Long and Minister of National Defense Phan Van Giang asked and encouraged volunteers to test the vaccine against COVID-19 Nano Covax. Photo: PV. On June 11, the Military Medical Academy said that this unit has started to deploy the phase 3 trial injection of the COVID-19 Nano Covax vaccine for the first 19 volunteers. On the day of injection for 200 people, divided into 2 groups. Accordingly, one group injected the Nano Covax vaccine with a dose of 25mcg, the other group injected a placebo with aluminum excipients. Military medical students will inject 1,000 volunteers in the first time. According to the research outline, phase 3 will test on about 13,000 volunteers in many provinces such as Hanoi, Hung Yen, Long An, Tien Giang… At the Military Medical Academy, there are currently more than 7,000 volunteers registered to participate in the trial, of which more than 600 people have been screened and are eligible to participate. Besides, IVAC’s Covivac vaccine is also preparing to complete phase 1 trial and enter phase 2 in July 2021. Regarding the subjects of vaccination, according to Deputy Minister Tran Van Thuan, in addition to the priority subjects for COVID-19 vaccination under Resolution 21, the Ministry of Health has added workers in industrial zones and will propose more subjects working in establishments dealing in essential goods.

National Assembly Chairman Vuong Dinh Hue visits the vaccine research and production laboratory of the Military Medical Academy – Photo: Thanh Chung A representative of the Military Medical Academy said that it has successfully researched and manufactured a test kit to detect the new strain of corona virus (SARS-CoV-2) by real-time RT-PCR method, used at more than 100 facilities. healthcare throughout the country and exported to 18 countries around the world. Continuing to research and successfully manufacture Amphabio PCR test kits with the ability to test quickly and in large quantities at the same time, which is currently being used effectively in Bac Giang province. Notably, the Academy has been trusted by the Ministry of Health to carry out phase 1 and 2 clinical trials for the Nano Covax vaccine against Covid-19 (from December 2020) and both are generating antibodies. It is expected that from June 2021, there will be a phase 3 clinical trial, deploying over 13,000 volunteers 18 years of age or older. In addition, the Academy has mobilized staff to support the prevention and control of Covid-19 in Quang Nam, Bac Giang, Bac Ninh and Laos. National Assembly Chairman Vuong Dinh Hue visited and worked at the Military Medical Academy – Photo: Thanh Chung Speaking at the meeting, National Assembly Chairman Vuong Dinh Hue highly appreciated the efforts and achievements that the Military Medical Academy has achieved during 72 years of construction and growth, which has received the most noble achievements of the Party. , state and military. In particular, in the prevention and control of the Covid-19 epidemic, the Military Medical Academy is one of the active, active and effective participating units. National Assembly Chairman Vuong Dinh Hue said that in the current period, the task of effective disease prevention is the focus in the implementation of “dual duty”, so vaccines are an important “weapon”, strategic, decisive issues to end and conquer disease. “The XIII Congress of the Party has set a key task of focusing on controlling the Covid-19 pandemic, mass vaccination of the community with Covid-19 vaccine. Therefore, the Military Medical Academy closely coordinates with other agencies. Relevant ministries and sectors urgently speed up the phase 3 clinical trial of the Nano Covax vaccine against Covid-19, striving for early results to have a preventive vaccine for the community” – National Assembly Chairman assigned. The National Assembly Chairman also suggested that the Military Medical Academy should identify challenges such as, there are many domestic and foreign facilities focusing on research and production of vaccines. Mr. Vuong Dinh Hue analyzed that if there is no superior vaccine in terms of quality, price and supply quantity, it will fall into an opportunity trap. A number of vaccine products have been born and put into circulation in countries, along with rigorous testing by the health systems of countries, approved by WHO. However, there is currently a vaccine that has shown its effectiveness compared to the new variant; There are scenarios of monopolistic production, imposing price and quantity, but also opportunities for technology transfer in the direction of humane sharing. “So, the Military Medical Academy to research and produce vaccines, it is necessary to have the shortest time of antibodies, the shortest number of days, the better. The side effects must be minimized, especially for people with underlying diseases. and weak health. Having the ability to resist and adapt to new variants of the virus,” suggested the National Assembly Chairman. At the meeting, the Military Medical Academy proposed to allow the Academy to organize the implementation of the project “Research and Development Center for Human Infectious Diseases” which was approved by the Prime Minister at the government office. Document No. 164 dated December 31, 2020 of the Government Office, which is expected to have a number of functions and tasks such as research on pathogens, development and production of biological products for detection, diagnosis and treatment of diseases. treating infectious diseases, especially dangerous and extremely dangerous diseases, contributing to protecting the health of soldiers and people, especially in emergency and disaster situations. Researching foundational technologies in development, technology transfer and production of vaccines against infectious diseases, especially dangerous and dangerous infectious diseases. Agreeing with the proposal of the Military Medical Academy, National Assembly Chairwoman Vuong Dinh Hue suggested, the Academy needs a state-level scientific research program and emergency approval to research and test. production of vaccines for human infectious diseases. The Ministry of National Defense shall assume the prime responsibility for, and coordinate with relevant agencies in, facilitating and directing the Military Medical Academy to accelerate the implementation of the project “Research and development center for human infectious diseases vaccines” under the theme of: Government policy. Also this afternoon, National Assembly Chairman Vuong Dinh Hue visited the vaccine research and production laboratory at the Military Medicine Research Center building, under the Military Medical Academy. The National Assembly Chairman graciously encouraged the forces directly involved in research, production and volunteers to test the Covid-19 vaccine.

In this phase 3, Nano Covax vaccine will be tested in multi-centers at domestic facilities with the deployment of vaccination for 13,000 volunteers. Specifically, in the North, experimental injections were carried out at the Military Medical Academy (Hanoi) and in Hung Yen province; The southern area is carried out by the Pasteur Institute in Ho Chi Minh City, and is planned to be injected in 2 provinces: Long An and Tien Giang. In the immediate future, in phase 3, 1,000 registered volunteers will be tested, and then continue to recruit more. In this phase 3, there is also research and evaluation of the effect of the vaccine against the variant of the SARS-CoV-2 virus found for the first time in India. By the end of September 2021, after the phase 3 trial is completed, depending on the test results and epidemic developments, the vaccine will be considered for approval for emergency use on a large scale in our country. Step 1: Visit https://www.bluezone.gov.vn or download directly at App Store or CH Play. Step 2: Once downloaded, the application will ask for permission to use Bluetooth to record contact with other Bluezone installed users. If Bluetooth is not open, drag the status bar and turn on Bluetooth; or go to Settings, select Bluetooth and turn it on. Step 3: Once the installation is done, click Scan Around. If someone near you less than 2m has used Bluezone, the application will automatically identify these users and put them in the contact list.

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.

People were tested with Nano Covax vaccine phase 2. In phase 2, the volunteers were divided into 4 groups, including groups of injections with doses of 25mcg, 50mcg, 75mcg and placebo. All 3 doses of 25mcg, 50mcg and 75mcg injected to volunteers were immunogenic, of which the 25mcg dose level is considered to be the most effective. The research team will report the results of phase 2 to the Ministry of Health. It is expected that on April 27, it will submit to the National Bio-Medical Research Ethics Council of the Ministry of Health a plan to deploy the clinical trial injection of Nano Covax vaccine phase 3. According to the plan, Nano Covax vaccine in this phase will be tested in large groups, from 10,000 to 15,000 people, starting from May 5-2021. The research team is expected to propose a single test injection dose of 25 mcg. Previously, as reported by the New Hanoi News, Nano Covax was the first Covid-19 vaccine in Vietnam to be injected for clinical trials in humans, researched and developed by Nanogen Technology Joint Stock Company. In phase 2, there were 560 volunteers registered for the trial, expanding the subjects from 18 to over 60 years old, of which, some people had background diseases such as hypertension, dyslipidemia, diabetes, heart disease. 1 degree circuit … not too heavy. The test vaccination of Covid-19 Nano Covax vaccine phase 2 was held at two bridge points: the Military Medical Academy and the Pasteur Institute of Ho Chi Minh City (participating in the study, conducted in Ben Luc district, province. Long An). For objective reasons, there were 4 people who asked to withdraw from the list of experimental injections. As a result, 556 people completed the second phase of Nano Covax vaccine trial. Step 1: Access to https://www.bluezone.gov.vn or directly download at App Store or Play Store. Step 2: Once downloaded, the app will ask for Bluetooth permission to record contact with other Bluezone installed users. If Bluetooth isn’t open, drag the status notification bar and turn on Bluetooth; Or go to Settings, select Bluetooth and turn it on. Step 3: After the installation is complete, click Scan Around. If someone near you less than 2m has used Bluezone, the application will automatically identify these users and put them on the contact list.