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Phase 3 human trials of homegrown Nano Covax kick-started

VGP - The third and final phase of human trials of Nano Covax vaccine, developed by Vietnamese Nanogen Pharmaceutical Biotechnology JSC, officially started on June 7.

06/07/2021 13:43

The third phase with the participation of 13,000 volunteers will be carried out by the Military Medicine University in Hung Yen province and by the HCMC Pasteur Institute in the southern provinces of Long An and Tien Giang.

As many as 1,000 first volunteers have been selected for the trials at the Military Medicine University and Ben Luc district in Long An province. The group would be administered with 25mcg, the lowest dose for this stage.

As scheduled, the third phase would be completed at the end of this September.

The third phase of trials is relatively difficult due to complicated developments of the COVID-19 pandemic in Viet Nam, said Chu Van Men, Director of the Center for Clinical Trials and Bioequivalence under the Military Medical University.

Due to the current COVID-19 resurgence, safety measures must be ensured throughout the phase, said Chu, adding that if any case of COVID-19 patient (or people who have contact with COVID-19 patients) accidently appears at the testing sites, the testing site would be closed and the trial phase would be suspended.   

So far, Nano Covax vaccine manufacturer has been ready to stockpile raw materials and prepared procedures for mass production if the vaccine is licensed by the Ministry of Health.

Earlier, results from the second stage of human trials of Nano Covax showed the vaccine is safe.

The second stage trials were conducted on 556 volunteers who were divided into four groups, with 80 people injected with a placebo and three other groups administered with 25mcg, 50mcg, and 75mcg doses.  All of the vaccinated volunteers had developed antibodies against COVID-19 at different levels.             

Navo Covax vaccine started testing on humans on December 17 last year with 60 voluntters.  

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.

In 2021, Viet Nam needs 150 million doses of vaccine to vaccinate 75 million people. The estimated required funding for the vaccine and vaccination campaign is more than VND25 trillion, including about VND21 trillion for vaccine purchase./.

By Kim Loan