Developed by the Nanogen Pharmaceutical Biotechnology JSC, Nano Covax is Vietnam’s first COVID-19 vaccine candidate and was approved by authorities for clinical trials last December.
According to Associate Professor Dr Chu Van Men, Director of the university’s Centre for Clinical Trials and Bioequivalence, the third phase targets 13,000 people aged from 18-75, with an optimal dosage of 25mcg.
Apart from the university, the third phase, also the final one, will be carried out in the northern province of Hung Yen and the Mekong Delta provinces of Long An and Tien Giang.
Following the clinical trials in Phase 2, which lasted three months, all volunteers experienced an increase in antibody levels against the coronavirus. This is a positive sign that not only makes it possible for developers to safely speed up Phase 3 but also raises hopes that a Made-in-Vietnam vaccine will soon become available amid the growing complexity of the pandemic both locally and regionally.
As of June 11, more than 6,500 volunteers had registered for this phase, which aims to further test the safety and efficacy of the vaccine in humans before mass production begins.
Associate Professor Ho Anh Son, Deputy Director of the university’s Institute of Biomedicine and Pharmacy, said a dossier will be submitted to the Government, the Ministry of Health, and the National Council for Ethics in Biomedical Research seeking emergency approval for conditional use in mid-September, or 42 days since the first 1,000 volunteers received their second shot.
Phase 2 trials began on February 26 involving 560 volunteers divided into four groups, with three administered doses of either 25mcg, 50mcg, or 75mcg and the fourth a placebo.
With this phase now completed, volunteers will continue to undergo health monitoring for six months since the first shot to evaluate the vaccine’s ability to build immunity against the virus.
Many COVID-19 vaccines around the world are 90% effective and some just 60-70%, Son said. With Nano Covax, all volunteers have produced immune responses against COVID-19.
The study found an increase in antibody levels in all volunteers, Son continued, and all were in good health and no one needed drugs or emergency care. It was a very encouraging result and the vaccine is safe for humans so far, he emphasised.
Another domestic vaccine candidate, Covivac from the Institute of Vaccines and Biological Medical (IVAC) in Nha Trang city, Khanh Hoa province, is preparing for Phase 1 trial data to be reviewed by the Ministry of Health and could start Phase 2 around late-June or early-July if results are deemed acceptable.
Another locally-developed COVID-19 vaccine, from Vabiotech, is in pre-clinical trials on animals, while yet another from Polyvac (the Centre for Research and Production of Vaccines and Biologicals, under the Ministry of Health) is still under laboratory research.