Human trials of made-in-Vietnam COVID-19 vaccine to be deployed in three stages

Monday, 2020-12-07 12:54:26
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Vietnam will conduct the first phase of human trials of a locally made COVID-19 vaccine from the middle of this week.
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NDO – A locally made COVID-19 vaccine is expected to be tested on humans during a three-stage trial starting from this week.

>>> Vietnam to start human trials of Covid-19 vaccine on December 10

The initial phase will be carried out on about 20 volunteers from December 10, as announced by the Ministry of Health.

On December 5, the ministry confirmed that Vietnam will conduct human trials of the vaccine developed by Nanogen Pharmaceutical Biotechnology JSC, using recombinant protein technology. The Vietnam Military Medical University will recruit volunteers from December 10, after which injections will be conducted.

Dr. Do Minh Si, Nanogen Director of Research and Development, said the most important test is the preclinical testing step to demonstrate immune response in animals, which is just one of several criteria for the human trial to be allowed to take place. Nanogen’s vaccine has been successfully tested in mice and monkeys.

Nguyen Ngo Quang, Deputy Director of Agency of Science, Technology and Training under the Ministry of Health, said that the experimental vaccine must be assessed for toxicity, safety, immunogenicity and especially its protective effect on animals and primates to convince the evaluation board before licensing human trials, with the aim of ensuring safety and effectiveness and determining the effect of the vaccine against COVID-19.

On the basis of the complete pre-clinical results, the Ethical Council in Biomedical Research of the Ministry of Health will consider all aspects, including issues related to the outline design, protecting the integrity of research participants, the conditions of the research facilities as well as the strategies that can be implemented in the evaluation process on the volunteers.

"These are very strict requirements that must be reviewed, evaluated and approved by the Ethical Council," Quang said.

Regarding the roadmap for human testing, the Vietnam Military Medical University will conduct injections from December 10. It is expected that about 20 healthy volunteers will receive the first injections of the vaccine.

A small group of about 1-2 people will be vaccinated first and monitored for responses within 24-72 hours before starting the next injection of about 18-19 people.

After three months of testing in a small group, the vaccine will be tested on about 400 people.

According to the military-run facility, it is now ready with all equipment and personnel for the trial as well as monitoring the health of the volunteers and treating any undesirable reactions immediately during the vaccination.

The Ministry of Health affirmed that its ethics council will carefully consider and allowing the next important steps in human trials of COVID-19 vaccine.

According to experts, those joining the vaccine trial are selected very carefully. They are healthy volunteers with no background illnesses nor medical history. These individuals are carefully surveyed about their health history and allergy status (to drugs, food ...).