Vietnam to test Covid-19 vaccine on humans in November
It is expected that 20 people will be vaccinated with the Covid-19 vaccine in phase 1. After that, the vaccine will be tested on about 600 people in phase 2, and more than 10,000 people in phase 3.
According to Mr. Nguyen Ngo Quang - Deputy Director of the Department of Science, Technology and Training, Ministry of Health, the Covid-19 vaccine researched and produced by NANOGEN Pharmaceutical Biotechnology Company Limited is expected to be tested on humans in November after completing the dossier.
To prepare for testingCovid-19 vaccineIn order to conduct phase 1 clinical trials on humans, the Ministry of Health met with the Military Medical Academy on November 2, requesting the reconstruction of facilities to conduct phase 1 clinical trials according to regulations, ensuring safety and effectiveness. Along with that, the Ministry of Health will send a group of experts to monitor and supervise this testing process.
“It is expected that 20 people will be vaccinated with the Covid-19 vaccine in phase 1. Phase 2 will test about 600 people, and phase 3 will be more than 10,000 people,” said Mr. Quang.
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NANOGEN researches and produces vaccines using recombinant technology, and is one of two manufacturers that the Ministry of Health has high expectations for. Recombinant technology uses biological techniques to separate and recombine SARS-CoV-2 genes into bacteria or a suitable cell line.
Previously, NANOGEN tested the toxicity of the Covid-19 vaccine at the National Institute of Hygiene and Epidemiology, and also conducted a challenge test (a challenge test is to create a complete vaccine that is injected into animals, then exposed to SARS-CoV-2 to test its protective efficacy). The unit also sent test samples to a laboratory in Korea for parallel testing.
The Ministry of Health said it will provide maximum support to manufacturers, including allowing overlap in research and clinical trials on animals and humans, but requires strict compliance with regulations on ensuring the safety of volunteers and ethical requirements in biomedical research.
NANOGEN is one of four Vietnamese units participating in Covid-19 vaccine research (along with the Institute of Vaccines and Medical Biologicals (IVAC), Vaccine and Biologicals Company No. 1 (VABIOTECH), and the Center for Research and Production of Vaccines and Medical Biologicals (POLYVAC). IVAC's vaccine is in the challenge testing phase on primates, while VABIOTECH is testing the vaccine on monkeys./.