Half a year at the speed of vaccine research Covid-19 Vietnam
The complicated vaccine research process needs to be completed within 18 months, forcing the IVAC scientists to work hastily for the past half year.
Master Nguyen Sy Tuan, Deputy Department of Medical Biology (IVAC) in Nha Trang, wears gloves when introducing a small green bottle called Covivac. This is the complete Covid-19 vaccine product of IVAC after more than half a year of research, and is the second Covid-19 vaccine in Vietnam to complete animal testing, preparing for human trials.
Master Tuan said, Covivac was developed by IVAC from the NDV-Lasota-S candidate strain transferred by the US in May 2020. The goal is to research, manufacture the vaccine, and complete a three-phase clinical trial in 18 months. Vaccine strain is a virus strain used to produce vaccines, but not officially, for use in laboratory or preclinical research.
According to Dr. Duong Huu Thai, Director of IVAC, the research and development process for vaccines is complicated, lengthy and expensive. This process can be roughly divided into 3 phases according to the scale of laboratory research, small-scale trial production and large-scale production. If divided by research phase, there is a research phase to create a product, a quality assessment stage, a safety and effectiveness evaluation phase on experimental animals, a clinical trial on humans (phase 1, 2, 3), registration for circulation and post-licensing review.
"However, no matter how divided the way, usually to successfully develop a vaccine takes about 10 years" Mr. Thai said.
With the Covid-19 vaccine, the team set a goal of completion in 18 months, which is a difficult problem and the first time that IVAC has to solve. IVAC works with the US to research into vaccine production. In the context of a pandemic, the transaction, transportation and technology transfer between countries are difficult and often prolonged, making IVAC worried that the project progress will be affected.
The research team decided to select the technology of culture on chicken eggs with embryos for vaccine production. This technology has been mastered by IVAC, used to successfully produce 2 seasonal flu vaccines and H5N1. Besides, the institute also has French chicken breeds that get clean eggs, suitable for the study. The advantage of this technology is that it is easy to invest in, easy to deploy and consistent with IVAC's scientific and technological capacity.
In addition, due to the traditional technology, the infrastructure, equipment, production processes, and testing methods have been previously established with pandemic influenza A / H5N1 vaccine. Thus, IVAC has initial advantages in research and production of new vaccines.
The vaccine manufacturing process goes through many steps. First, strain NDV-Lasota-S is injected into ovid ovarian fluid. This step helps in culturing the virus. When they are duplicated, the fluid containing the virus in the eggs is sucked out to refine and filter. Then, the virus is inactivated, no longer capable of causing disease, but retains its original properties and then goes into the vaccine manufacturing dosage form.
The initial results were quite good, the strain developed well and adapted to the existing technological process. Despite having the initial advantage, mastering the technology, scientists still have to race against time due to having to do it many times in the laboratory when some results are unsatisfactory. For several weeks, the team stayed at the laboratory, not going home and stocking dry and canned foods, and focused on working day and night.
"There must be enough research data and great care must be taken to ensure absolute safety when testing on humans, safety for test participants", said IVAC Director.
Their efforts paid off when the finished product, dubbed Covivac, was successfully tested by the end of December 2020. Currently, Covivac has basically completed animal trials, the results of the vaccine safety and good immunogenicity.
IVAC has submitted a registration dossier for clinical trials on humans and sent to the Ministry of Health at the end of December 2020, and is expected to be approved and tested on humans.
Expected 125 people are testing phase one, taking place in late January 2021. After that, 300 people will test phase two, which will take place in April 2021. Phase three is expected to take place in July-August 2021, however, there is no specific plan and needs to depend on the test results of the previous two phases. Thus, the progress of research and production of Covivac is still ensured according to the original plan.
Sharing about the current test results, Mr. Thai said: "If we don't go, we will never come. Currently is the beginning, there are still many challenges ahead, but we have faith and dedication on the basis of existing capacity ".