Hanoi (VNA) - The clinical trials of Vietnamese COVID-19 vaccine candidate Nano Covax are set to enter Phase 3 this month with the optimal dosage of 25mcg, aiming to further test the safety and efficacy of the vaccine in humans before mass production begins.
Following the clinical trials of 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.
Developed by the Nanogen Pharmaceutical Biotechnology JSC, Nano Covax is Vietnam’s first COVID-19 vaccine candidate approved by authorities for clinical trials from last December.
The trials of Phase 2 began on February 26, involving 560 volunteers divided into four groups, with three administered doses of either 25mcg, 50mcg, and 75mcg, while the fourth received a placebo.
As this phase is now completed, volunteers continue undergoing 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 percent effective and some just 60-70 percent, said Associate Professor Dr Ho Anh Son, deputy director of the Vietnam Military Medical University’s Institute of Biomedicine and Pharmacy. With Nano Covax, all volunteers have produced immune responses against COVID-19, he added.
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.
Up to 13,000 volunteers will join the third clinical trials that are about to start early this month, he went on, and a large number of medical staff will be deployed to help the trials in ten cities and provinces nationwide.
He noted that as the vaccine has proven safe after the first and second phases, the standard for recruiting volunteers has been relaxed and the age bracket expanded to 18-75 years old.
Another domestic vaccine contender, 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, and another from Polyvac (the Centre for Research and Production of Vaccines and Biologicals, under the Ministry of Health) is still under laboratory research./.