A representative of Ministry of Health said that the vaccine to be tested in humans must meet the criteria such as safety, immunogenicity and especially protective effect on animals.
Officially on coming December 10, Vietnam will begin the process of testing COVID-19 vaccine in humans. This information, said by the Ministry of Health, received great attention from the public. The preparatory stages for the clinical trial are now complete with rigorous testing of safety criteria of the vaccine.
Production line of COVID-19 Vaccine of Vietnam
After 6 months of research, with antigen and recombinant proteins technologies - similar to those in the world, vaccine batch of one of the research units will conduct a first clinical trial in humans in Vietnam, has had good immune response results in animals such as mice and monkeys.
Immune response in animals is just one of a number of criteria to be tested in humans. The representative of the Ministry of Health said that the vaccine to be tested in humans must meet the criteria such as safety, immunogenicity and especially protective effect on animals. These criteria will be evaluated by domestic and foreign organizations.
Vietnam Military Medical Academy will be in charge to recruit volunteers starting from December 10, after which the test will be conducted.
It is expected that about 20 healthy volunteers will be vaccinated. A small group will be injected first and monitored for reactions within 24 - 72 hours and then continue remaining volunteers. After 3 months of testing in small group, the vaccine will be tested in 400 people. Ethics Council of the Ministry of Health will carefully review the decision to allow further steps.
According to the Ministry of Health, in addition to NANOGEN, which has prepared the phase 1 clinical trial as mentioned above, there are now IVAC and VABIOTECH that have completed the laboratory-scale production process. The Ministry of Health said that they will help create favorable conditions for vaccine producers such as minimizing administrative procedures and quickly resolving product registration and licensing upon completion of testing process.