Vials of the locally-made Nanocovax vaccine. (Photo: Quynh Tran)
The race to research and produce COVID-19 vaccines in the world is going on, with some have been initially commercialised and used for injection, such as Pfizer (USA), AstraZeneca (UK-Sweden), Sputnik V (Russia) and Sinovac (China). In particular, in Vietnam, with the determination to join the world in studying vaccines to fight the pandemic, the Ministry of Science and Technology has ordered Nanogen Pharmaceutical Biotechnology Joint Stock Company (Nanogen) to research and manufacture a local COVID-19 vaccine. After just five months, with the highest spirit in sparing no efforts, boosting creativity and speeding up the research, Nanogen has successfully produced its Nanocovax vaccine and put it into clinical trials. It takes time for the results of the human trials, however, this success has affirmed the huge scientific potential of Vietnam.
Many believe that the initial success of Nanogen has "luck" in choosing the technology of vaccine production, which is the recombinant protein technology. In the context that coronavirus has caused many dangerous epidemics in the mankind history but no vaccine has been licenced for circulation, the choosing of technology to develop vaccines is the biggest difficulty for COVID-19 vaccine researchers and producers. Therefore, like "touch and go", each country chooses different technologies, such as recombinant protein vaccines, nucleic acid vaccines (DNA and RNA vaccines), or inactivated vaccines. Vietnam, with a lot of experience in vaccine production, has never approached research on corona vaccines before. Facing an urgent need to research and manufacture vaccines against the COVID-19 epidemic, domestic units also followed different research directions on the basis of their strengths. Genomic sequencing showed that S protein and its components encoded in the genome are the main antigens that stimulate antibodies to neutralise the virus. On that basis, the recombinant protein technology by Nanogen Company used a viral gene segment that encodes S protein to express on Chinese hamster ovary cells to produce S protein, then harvested and purified it as raw a material for vaccine production. The vaccine is adsorbed into aluminium-containing adjuvants to enhance the immune response. When vaccinated, the body will create an immune response, the immune cells will remember and when we are infected with the virus, the body will quickly recognise and produce antibodies to destroy the virus. Explaining this "luck", Do Minh Si, Nanogen’s Research and Development Director, said that his company has been mastering this technology for over 10 years, so it only takes about five to six months for them to introduce a candidate vaccine for preclinical and clinical research. With this technology, Nanogen has had nearly two decades of research and production of drugs and bio-products to support cancer treatment. Ho Nhan, the company’s General Director, has spent his whole life pursuing this technology, since he was a student in the US.
This is also the first time that a private unit has stepped into vaccine research and production and has also shown its own advantages. Trinh Thanh Hung, Deputy Head of Department of Science and Technology for Economic-Technical Branches (under the Ministry of Science and Technology - MOST), said that in the fight against COVID-19, Nanogen has been assigned by the MOST to research and produce monoclonal antibody drug against COVID-19. With the momentum of nearly successful drug research, Ho Nhan made the daring decision to produce a vaccine, even though he knew it would be risky. Later, when the MOST and the Scientific Council selected researchers and vaccine producers to order vaccine production, Nanogen gained the “plus points” thanks to its research capability, modern production line and great determination. Its financial potential and modern equipment has contributed to shortening research time to a record (normally it takes from 5-10 years from knowing the pathogen to the commercial vaccine). Many scientists admitted that in producing vaccine antigens, research institutes can do it, but to produce finished vaccines, there must be a modern laboratory that meets the biological safety standards. Research funding totals VND28.6 billion (in which the State invests more than VND8 billion), but in fact, the project has cost the company more than VND200 billion, along with 100 employees working in laboratories.
Volunteers register to join the clinical trials of Nanocovax vaccine. (Photo: Thai Son)
A great advantage for domestic vaccine researchers and manufacturers when accompanying the world in COVID-19 vaccine research is to immediately inherit, exchange and share information and research results with their peers to develop their own products. For example, in 2002, when the coronavirus caused the SARS outbreak, the world took three to five months to deconstruct its genetic sequence. But now this process is completed in just a few days thanks to progress in gene sequencing technology. These studies are shared rapidly across open databases, making them accessible to users around the world. International and Vietnamese research results have contributed to shortening the research period for Vietnamese vaccines. In addition, the MOST has shortened administrative procedures, as well as connecting and activating all the resources to focus on supporting Nanogen. The National Institute of Hygiene and Epidemiology – where there is a class 3 biological safety cabinet – implemented two of the most difficult techniques that were carried out for the first time in Vietnam, including a neutral reaction (injecting vaccine into mice to check whether mice produce antibodies to neutralise the virus or not) and challenge test (re-infecting mice with the SARS-CoV-2 virus after vaccination to check the protective potency of the vaccine). The National Institute for Control of Vaccine and Biologicals shortened the procedures for testing the quality of the experimental vaccine, while the Vietnam Military Medical University focused on clinical trials. Challenge tests are usually performed on monkeys in the biological safety cabinets for animals in foreign countries, but since Vietnam does not have this room, domestic scientists have taken advantage of biological safety cabinet for virus culture and creatively performed tests on hamsters – with monkey-like virus susceptibility and in small size, suitable for laboratory conditions.
Despite having a lot of experience in clinical trials for many vaccines, while trusting preclinical test results and being ready for the first COVID-19 vaccine trials, Prof., Dr. Do Quyet, Director of the Vietnam Military Medical University, couldn't hide his worries. During a meeting of the grassroots Medical Ethics Committee of his academy, Quyet determined: “This test is like taking a gamble. If we do it well, we can do many other things in the future; otherwise we throw away all the prestige of the Military Medical University, the Ministry of Health and Nanogen Company. Therefore, each member in this local level council is required to promote the highest sense of responsibility to complete the documents submitted to the Medical Ethics Council of the Ministry of Health. If not, each will be personally responsible for any mistakes.” That meeting lasted from afternoon to evening that day, with all council members and lawyers turning over the conditions on the volunteers joining the human trials again and again to ensure their highest safety during the test injection. Even the leaders and employees of Nanogen have to "station" at the Military Medical University campus until the end of the trials. They have to work with the highest spirit and maximum support, because if everything is temporary, the academy will definitely stop the testing. Recently, Prof, Dr. Quyet happily said that volunteers were given a second dose of 50 mcg of Nanocovax vaccine and had no unwanted effects or serious complexities, so it is expected that by the end of 2021 there will be an official locally-made COVID-19 vaccine. At the beginning of the clinical trials, Vietnam was one of 40 countries around the world to have started clinical trials for COVID-19 vaccine. With the local production of diagnostic test kits for SARS-CoV-2 and its first vaccine against COVID-19, Vietnam has joined "a round table" with the world in several biomedical research fields. This initial success shows that the "order" from the MOST for COVID-19 vaccine research and production is timely and in accordance with the Party and State’s policy of taking business as the centre of innovation, while activating research institutes and management agencies to focus on providing maximum support for businesses.
Some wonder why Vietnam is still researching and producing its own COVID-19 vaccines when many countries around the world have already released commercial COVID-19 vaccines. Experts said that as the world missing out on further research on the SARS vaccine has made us passive against the current COVID-19 epidemic. Besides, the pandemic in not likely to disappear as quickly as the Ebola or SARS epidemics, but will repeat again, so the world is determined to have a technology ready for pandemic prevention. With that in mind, as one of the 42 countries in the world that can produce vaccines and has a National Regulatory Authority (NRA) on vaccine quality management meeting the World Health Organisation (WHO) standards, Vietnam needs to be responsible with the world in fighting against COVID-19. Meanwhile, without joining the world in COVID-19 vaccine research at this time, it is impossible to fully understand the concepts of this vaccine, the vaccine's interaction and the human immune system, from which offering solutions to control other dangerous diseases that mankind will surely face in the future. Therefore, other domestic vaccine manufacturers in Vietnam are also making efforts to research and develop their own COVID-19 vaccines, towards clinical trials on humans.