Prioritising resources to develop drugs for COVID-19 treatment
The above results once again affirm the efforts and responsibility of domestic scientists to join hands with the health sector to respond to the Covid-19 pandemic, as well as the timely support of management agencies for the goal of having drugs to protect people's health.
Potential Covid-19 treatment drug
VIPDERVIR has been researched by scientists from the VAST's Institute of Biotechnology since the Covid-19 epidemic began to break out in Vietnam in 2020. This is the first herbal medicine product studied on the SARS-CoV-2 virus with the coordination of the National Institute of Hygiene and Epidemiology, the National Institute of Drug Quality Control, and the Department of Pharmacology under the Hanoi Medical University.
According to Associate Prof, Dr. Le Quang Huan, who leads the project, the main effects of this drug are: preventing the adhesion of the virus to cells, blocking the ability of the virus to enter cells, inhibiting the ability of viruses to multiply in cells, and activating the immune system so that it can recognise, block, and eliminate viral particles.
Dr. Nguyen Ngo Quang, Deputy Director of the MOH's Department for Science, Technology and Training, said that the initial results show the success of scientists’ research efforts to serve COVID-19 prevention and control. The product has the advantage of being a herbal medicine with high safety, therefore, the National Ethics Committee in Biomedical Research has accepted the safety of the drug, agreeing to approve the clinical study protocol of VIPDERVIR medicine for COVID-19 patients.
People and the health sector all want good products, but they must be clinically evaluated so that they can be put into use soon to treat Covid-19 patients, especially patients with mild and moderate symptoms, in order to reduce the number of seriously ill patients. The health sector is currently approaching pharmaceutical drug products from abroad to treat viral load reduction for patients with mild and moderate symptoms, if this drug is good, it can change the treatment strategy for patients.
The Ministry of Health will direct units to accelerate product evaluation on Covid-19 patients with mild and moderate symptoms, with the goal of completing the trial period by the end of the year and considering the licensing of the product.
It is expected that the clinical trial phase will begin at the end of August at the National Hospital of Tropical Diseases. The second phase will be conducted a trial on 60 Covid-19 patients with mild and moderate symptoms, to evaluate the safety and ability of the doses to reduce the viral load and choose the optimal treatment dose. The third phase will experiment on 260 patients to evaluate the optimal dose. Patients will be tested to assess how many days they are negative for SARS-CoV-2 virus in the 14-day course of treatment. Currently, the product has been manufactured at a GMP-certified factory for herbal medicines to be ready to be included in the clinical trial on patients.
Accelerating the clinical trial process
Many experts currently believe that regulatory agencies should facilitate the acceleration of clinical trials on patients in order to quickly, objectively and scientifically demonstrate the effectiveness of the drug, in the context that the number of Covid-19 patients in hospitals is enough for the sample size requirement. If there is a delay, the product may have to stop the midterm clinical trial when the number of patients gradually decreases.
The research team said that the results of the clinical trial could open the door to new ideas for developing other products for the Covid-19 prevention and control. When there are more studies, there will be more good products, more options for patients. This initial success clearly demonstrates the effectiveness of research collaboration between basic science researchers and clinical block scientists in the process of researching products for people's healthcare. That wisdom, experience, and collaboration needs to be leveraged in the clinical trial sprint.
In addition, it is necessary to have the companionship of businesses and sponsors so that scientists' products can have financial conditions for the most expensive period, which is clinical trials. It is known that so far, Vinh Gia Pharmaceutical Joint Stock Company has sponsored the research team during pre-clinical and clinical research and pledged to always provide financial support until the product is licenced. This is a sustainable model for scientists' research results to be quickly accessed and used by the society, but it is also necessary to provide timely support from regulatory agencies for an objective and fast clinical trial process.
Assoc. Prof, Dr. Chu Hoang Ha, VAST Vice President, assessed that the research and development of drugs based on Vietnamese herbal sources, combined with achievements in traditional medicine research and research modern research on bioinformatics and biotechnology has shown the initiative, creativity and determination of the research team in the task of epidemic prevention and control.
Assoc. Prof. Dr. Nguyen Duy Thuan, former Deputy Director of the Vietnam Academy of Traditional Pharmacy and Medicine, also said that the pre-clinical research results of the VIPDERVIR drug highlight the agility in research and are a bright spot in the development of traditional medicine combined with modern medicine in the treatment of newly arising diseases.
The State needs to have stronger policies to encourage the development of traditional medicine. Vietnam's advantage is that the country already has available sources of medicinal materials and drug extraction processes, along with international studies, that can be applied to new research goals.
HA LINH
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