Volunteers injecting experimental vaccine Covivac. Photo: General Writing Domestic vaccines can reach 20-30 million doses/year According to the Ministry of Health, so far, the country has two manufacturers researching and developing vaccines against Covid-19.
The Nanocovax vaccine of the Nanogen Pharmaceutical Biotechnology Joint Stock Company has been approved for a phase 3 clinical trial (TNLS). In the past few days, the Military Medical Academy has administered experimental injections to volunteers aged 18.
According to the research outline, phase 3 will test on about 13,000 volunteers in many provinces and cities such as Hanoi, Hung Yen, Long An, Tien Giang, etc. In the North, the Military Medical Academy will act as the focal point for deployment. at Military Medical Hospital 103 and Hung Yen province’s preventive health center deployed locally. The southern area will be professionally handled by the Pasteur Institute in Ho Chi Minh City, in collaboration with the preventive health centers of Long An and Tien Giang provinces.
At the Military Medical Academy, there are currently more than 6,000 volunteers registered to participate in the trial, of which more than 600 people have been screened and are eligible to participate. In the immediate future, in the first phase of the TNLS phase 3, the Military Medical Academy will test 1,000 people. According to the Military Medical Academy, before that, in stages 1 and 2 of the Nano Covax vaccine trial, 100% of people who injected immunity were protected against the attack of the SARS-CoV-2 virus.
In the phase 3 trial, the Nano Covax vaccine was administered to volunteers from 18 years of age, and there was no maximum age limit for the trial participants. Currently, the oldest person to register for TNLS injection phase 3 is 83 years old. Nano Covax vaccine will also be administered to volunteers with chronic diseases such as hypertension, diabetes (stable disease, do not inject during acute phase) to evaluate the results of immunogenicity. fluid, post-injection reaction… The results of the phase 3 clinical trial are the basis for the Ministry of Health to grant emergency permits and widely inject people to prevent the Covid-19 epidemic, which is expected in the fourth quarter of this year. Earlier, during a working visit to the Military Medical Academy, National Assembly Chairman Vuong Dinh Hue asked the Military Medical Academy to continue to closely coordinate with relevant ministries and sectors to urgently accelerate the implementation of clinical trials. Preparing phase 3 of Nanocovax vaccine, striving for early results to have a preventive vaccine for the community. However, when manufacturing, vaccines must ensure superiority in antibody generation time, with the shortest number of days; minimize side effects to a minimum, especially for people with weak health and underlying diseases; at the same time, must be able to resist and destroy future mutations. In addition, the COVIVAC vaccine of the Nha Trang Institute of Vaccines and Biologicals, is currently in the first phase of the TNLS and is about to be transferred to the second phase of research in Thai Binh.
According to the Ministry of Health, the COVIVAC vaccine is expected to produce about 6 million doses per year and can increase capacity when invested. Meanwhile, with the Nanocovax vaccine, which is expected to produce about 20-30 million doses per year, Nanogen Pharmaceutical Biotechnology Joint Stock Company can increase its capacity when invested.
A vaccine is coming soon that only requires one dose
Information from the Department of Science and Technology (Ministry of Health), a Vietnamese enterprise has discussed and negotiated with the US manufacturer on conditions for transferring technology to produce Covid-19 vaccine from mRNA essence. It is known that this vaccine only needs to be injected with a single dose of 5 mg, has high protection (based on the results of TNLS phase 1, 2), has a storage temperature of 20 – 80 degrees Celsius, currently the vaccine has been tested. end of trial phase 1, 2).
The first factory following the manufacturer’s technology standards will increase the capacity of 100-200 million doses/year, and is expected to start production from the end of 2021 or the first quarter of 2022. In addition, the No. 1 Vaccine and Biological Products Company Limited (VABIOTECH) is also negotiating with a Japanese partner to receive the transfer of vaccine production technology to Vietnam. In addition, VABIOTECH signed an agreement with the Direct Investment Fund of the Russian Federation on the closure of Sputnik-V Covid-19 vaccine tubes from semi-finished products with a scale of 5 million doses/month starting from July 2021. , towards transferring production technology with the scale of 100 million doses/year.
According to Minister of Health Nguyen Thanh Long, vaccines are an important weapon to bring life back to normal. Therefore, the Politburo has a policy on import, research, production and technology transfer for vaccines. Along with creating maximum conditions and quickly solving procedures for businesses and localities to import vaccines, Vietnam also promotes research and domestic production of vaccines. Vietnam is one of the first four countries in the world to isolate the SARS-CoV-2 virus, paving the way for research and production of vaccines, and many positive prospects for people to soon receive domestic vaccines. In addition, the Ministry of Health has worked with many foreign partners, negotiated to buy vaccine copyrights, transfer technology so that Vietnam can get the vaccine as soon as possible and be independent in the source of vaccines used in the country.
Recently, the Ministry of Health has negotiated with Johnson & Johnson Corporation with the hope that this unit will transfer technology to set up a vaccine factory in Vietnam. According to Minister Nguyen Thanh Long, many large corporations in Vietnam want to participate in the global vaccine supply chain. Vietnam is also one of more than 40 countries that can produce vaccines for the vaccination needs of the people, so the vaccine production experience of Vietnamese factories is guaranteed. Vietnam’s national vaccine management system (NRA) has also been certified as meeting standards by the World Health Organization (WHO). Johnson & Johnson’s side commits that after working with the Ministry of Health, it will make efforts to implement solutions to speed up the supply process through the COVAX mechanism, so that Vietnam can have Johnson & Johnson’s vaccine as soon as possible. However, Minister Nguyen Thanh Long also said that, to ensure vaccine security, one of the very important issues is to ensure a sustainable financial source for vaccines. Therefore, the Minister wishes that the community, authorities and businesses continue to support the Vaccine Fund. Vietnam has self-produced many vaccines and put them into the expanded vaccination program, contributing to the eradication and repelling of many dangerous diseases. This is the premise for the successful production of a Covid-19 vaccine. In fact, the research and production of vaccines against Covid-19 faces many difficulties and challenges, but this is the inevitable path we must go if we want to actively supply vaccines to serve the people. Over the past time, the Ministry of Health and State management agencies have created all conditions for administrative procedures for units to conduct vaccine production in the most favorable way. We can fully expect a “made in Vietnam” vaccine because at the moment, everything is going well.

Senior Advisor of the Center for Emergency Response to Public Health Events, Assoc. Tran Dac Phu The success of a vaccine depends not only on the manufacturer, researcher, and manager, but also on the social community. Therefore, we call for the cooperation of society, all people with the health sector to have a clinical trial research program, first of all, to be safe and effective to have a product soon. vaccines produced by Vietnam for the community.

Deputy Director of the Department of Science, Technology and Investment (Ministry of Health), Dr. Nguyen Ngo Quang

According to Lieutenant Colonel, Associate Professor, Assoc. Prof. Dr. Chu Van Men, Director of the Center for Clinical Trials and Bioequivalence, Military Medical Academy, phase 3 injected the Nano Covax vaccine to 13,000 people and administered only a single dose group injection. at least 25 mcg and the placebo injection group. Specifically, according to the protocol approved by the Ministry of Health, the first 1,000 trial injectors of the first phase of phase 3, the volunteers are injected with the ratio of “6 people vaccinated, 1 person injected placebo”. The remaining 12,000 people injected according to the ratio “2 people vaccinated, 1 person injected placebo”. It is expected that the first phase of phase 3 will be conducted by the Military Medical Academy and the Pasteur Institute in Ho Chi Minh City with 1,000 volunteers, each with 500 people. Vietnam’s first COVID-19 vaccine tested in phase 3 on humans. Regarding the reason for choosing the dose group of 25 mcg, Assoc. Prof. Dr. Chu Van Men said that testing at 3 dose levels of 25-50-75 mcg showed that the vaccine was safe on volunteers, capable of generating immunity in 3 doses. There was no difference in dose groups. Therefore, the National Ethical Council in Biomedical Research, Ministry of Health decided to only inject 1 optimal dose of 25 mcg at this stage. Phase 3 is implemented in many centers in the country: The North is deployed by the Military Medical Academy as the focal point at Military Medical Hospital 103, in collaboration with the Preventive Medicine Center of Hung Yen province to deploy locally; In the South, the Ho Chi Minh City Pasteur Institute is the focal point to deploy, in collaboration with the Preventive Medicine Centers of Long An and Tien Giang provinces to deploy locally. After the phase 1 and phase 2 trials, the Nano Covax vaccine is judged to be quite safe, so the criteria for recruiting volunteers will be relaxed more than the previous two phases. 13,000 volunteers participating in phase 3, aged 18-75 years old, only need to check their 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. As of June 11, more than 6,500 volunteers have registered to test the Nano Covax vaccine against COVID-19 phase 3. Senior Colonel, Assoc. Prof. Dr. Ho Anh Son, Deputy Director of the Military Medical and Pharmaceutical Research Institute, Military Medical Academy added: “It is expected that by mid-September 2021, after about 42 days of the second injection. In two of the first 1,000 experimental injections, we will summarize the results of the quality assessment to report. If it is favorable, we will submit the dossier and propose the Government, the Ministry of Health, and the National Ethical Council in the study. In parallel with that process, the unit will continue to test the Nano Covax vaccine on 12,000 volunteers to continue to control the experimental injection and evaluate the effectiveness. protective power of vaccines”. During the testing process and after the antibody sample is available, the Military Medical Academy will coordinate with the Nanogen Pharmaceutical Biotechnology Joint Stock Company, the testing units to conduct the assessment of the ability to neutralize the SARS-CoV virus. -2 in the laboratory for existing virus strains to determine the development direction of vaccine research in the coming period. Through discussions with the expert group of Nanogen Pharmaceutical Biotechnology Joint Stock Company, in addition to recombinant protein technology, there are other technologies for research and production of vaccines. Nanogen as well as many Vietnamese scientists are very interested in mRNA technology – which has been of great interest to the world in recent years. This technology has the advantage of reacting very quickly to the disease, quickly getting a vaccine. According to available information, vaccines produced by this technology are very safe for human use. More information about the phase 3 trial, Lieutenant General, Prof. Dr. Do Quyet, Director of the Military Medical Academy, said that this trial phase is designed according to the adaptive design method, continuing to inject the experimental vaccine. trial and placebo group; health assessment at the time of the first injection, the second dose (done on the 28th day), the 35th day and the 42nd day after injection. The Director of the Military Medical Academy expressed confidence in the safety of the Nano Covax vaccine with the results achieved through the previous two testing phases. Specifically, the concentration of SARS-CoV-2 virus antibodies after the phase 2 trial injection showed that the antibody titre increased very high, from tens to hundreds of times. After the second injection, the volunteers had a physical examination (blood test, blood pressure measurement…) once a week to assess the amount of antibodies appearing in the body; then continue to be monitored for 6 months to get information, assess health as well as immunity ability. Up to now, 100% of volunteers who have been vaccinated with Nano Covax vaccine have produced antibodies in the blood. – Phase I (December 2020), the COVID-19 vaccine Nano Covax was administered to 60 volunteers. – Phase II (February 2021) injected over 554 people. From phase 2, the trial was conducted both at the Military Medical Academy and the Medical Center of Ben Luc district – Long An province (by the Pasteur Institute in Ho Chi Minh City).

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.