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20 people are expected to be tested for Covid-19 in stage 1. After that, the vaccine will be tested in about 600 people in phase 2, stage 3 is more than 10,000 people.
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 Co., Ltd. is expected to be tested in humans in November after completing the profile.
To prepare for the trial of the Covid-19 vaccine in humans, the Ministry of Health met with the Military Medical Academy on November 2 and asked to rebuild the facilities to carry out the regulatory phase 1 clinical trial, ensuring safety and efficiency. Along with that, the Ministry of Health will assign a group of experts to monitor and supervise this testing process.
“20 people are expected to be tested with Covid-19 in phase 1. In phase 2, it will be tested on about 600 people, stage 3 will be more than 10,000 people,” Quang said.
NANOGEN researches and produces vaccines using recombinant technology, one of the two manufacturers highly anticipated by the Ministry of Health. Recombinant technology uses a biological technique to separate and recombine the SARS-CoV-2 gene into an appropriate bacterium or cell line.
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Previously, NANOGEN tested the Covid-19 vaccine for toxicity at the National Institute of Hygiene and Epidemiology, and at the same time did a challenge test (the challenge test was to create a complete vaccine inoculated in animals, then expose the animal to SARS -CoV-2 to challenge protective efficacy). The unit also sent the test sample to a laboratory in Korea for a parallel challenge.
The Health Ministry said it would provide maximum support to manufacturers, including allowing early stages of research and clinical trials in animals and humans, but with a requirement to strictly comply with regulations. safety for volunteers, ethical requirements in biomedical research.
NANOGEN is one of four Vietnamese units involved in Covid-19 vaccine research (together with the Institute for Vaccines and Medical Biological Products (IVAC), Vaccine and Biologicals One Member Company Limited (VABIOTECH), China. Research Center Vaccine and Medical Biological Products (POLYVAC) IVAC’s vaccine is in a challenging primate testing phase, while VABIOTECH is testing the vaccine in monkeys.
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