Vietnam plans to run COVID-19 vaccine trials on 60 volunteers during the first phase this November.
Yesterday, Dr. Nguyen Ngo Quang, Deputy Director of the Department of Science, Technology and Training under the Ministry of Health (MoH), and leading experts in the field of vaccine research and testing had a working session at the Military Medical University (Ministry of Defence) on the preparations for the first phase of the trial.
Accordingly, the first unit to have the experimental vaccine for testing is Nanogen Biopharma in Ho Chi Minh City.
Dr. Quang said that the MoH would provide maximum and favourable support for evaluation and approval to help the vaccine trial be deployed as soon as possible this month.
Quang emphasised that clinical research units must strictly comply with regulations from the ministry on techniques and ethics.
They must be approved by the health ministry as having met standards regarding facilities, equipment and human resources, thus helping facilitate the evaluation of the effectiveness of vaccines after vaccination on volunteers as well as ensuring their safety.
As suggested by the manufacturers, the experimental vaccine will be injected on 60 volunteers. It is known that the candidate vaccine has been produced on a laboratory scale and is being tested and evaluated on mice and monkeys.
According to the World Health Organisation (WHO), the vaccine production process consists of four major stages, of which clinical trials are only a small part of the whole project.
Vaccines have to go through the first stage in laboratory and animal research. In phase 2 – human clinical study, research units will experiment across multiple stages with an increasing number of volunteers.
In large size trials with a huge number of volunteers, researchers evaluate on three criteria: the vaccine preventing disease, infection, and producing antibodies or other types of immune responses in relation to the pathogen.
Stage 3 is approval, licensing and production and finally comes quality control.
Source: Nhan Dan Online
