Vietnam kicks off clinical trials of homegrown COVID-19 vaccine

Clinical trials of COVIVAC, Vietnam’s second COVID-19 vaccine candidate and developed based on the new highly-infectious Coronavirus variants, were kicks-tarted on January 21. People, aged from 18-59 and residing in Hanoi, can register to participate in the trials of this vaccine. COVIVAC, which was created based on studies of new SARS-CoV-2 variants, demonstrated high immunogenicity during pre-clinical trials. Developed by the Institute of Vaccines and Medical Biologicals (IVAC) based in the south central province of Khanh Hoa, the vaccine is expected to have a price tag of around 60,000 VND (2.59 USD) per dose. Many students registered to be injected with Vietnam’s second homegrown candidate vaccine COVIVAC. (Photo: VietnamPlus)

Volunteers register to participate in NACOVAX trials. COVIVAC vaccine is the second vaccine researched and developed by Vietnam using primary chicken embryo cell culture - a technique the Institute of Vaccines and Medical Biologicals (IVAC) used previously to successfully produce seasonal flu vaccines, which were exported to many countries throughout the world. It is the result of cooperation between the Nha Trang-based Institute of Vaccines and Medical Biologicals (IVAC) and a number of partners, including the Hanoi Medical University, the Icahn School of Medicine at Mount Sinai in New York City, the University of Texas in Austin, and the US-based health organisation PATH. (Photo: VietnamPlus)

People, aged from 18-59 and residing in Hanoi, can register to participate in the human trials of this vaccine.  At each registration desk at the Hanoi Medical University, volunteers carefully read the contents in the registration form and listen to guidance and explanation from medical workers. Volunteer participants will receive two shots (vaccine or placebo) and the second jab will be administered 28 days after the first one. The first shot is scheduled to be injected at the Hanoi Medical University in February. If data on health conditions of volunteers on their 43rd day shows that the vaccine fulfils safety criteria and produces antibodies effective in COVID-19 prevention, the second phase will be rolled out with a larger number of volunteers. (Photo: VietnamPlus)

Vietnam has managed to contain the spread of COVID-19 so far and is among a few countries making strides in vaccine development. The pre-clinical phase has proven that the COVIVAC vaccine has many advantages, including high immunogenicity and suitability for infrastructure at vaccination facilities in Vietnam, as well as effectiveness against SARS-CoV-2 variants. COVIVAC has undergone pre-clinical trials in India, the US, and Vietnam, and results showed that it satisfies all conditions to be tested on humans. The vaccine requires to be stored at 2-8 degree Celcius, while Pfizer/BioNTech vaccine must be kept at minus 70 degree Celcius and can only be used within five days at room temperature. (Photo: VietnamPlus).

The hall of the Hanoi Medical University is full of students and volunteers, who register to join clinical trials of COVIVAC vaccine on humans. Volunteers for COVIVAC trials will be divided into five groups, with three groups to receive vaccine  without adjuvants with three doses of 1 mcg, 3 mcg and 10 mcg, one group to receive 1-mcg dose with adjuvants and another to receive placebo. They will receive two shots (vaccine or placebo) and the second jab will be 28 days after the first one. The first shot is scheduled to be injected at the Hanoi Medical University in February. If data on health conditions of volunteers on their 43rd day shows that the vaccine fulfils safety criteria and produces antibodies effective in COVID-19 prevention, the second phase will be rolled out with a larger number of volunteers. (Photo: VietnamPlus)

Volunteers wait to register for the trials. Pre-clinical period proved that COVIVAC has many advantages, including high immunogenicity and suitability for infrastructure at vaccination facilities in Vietnam, as well as effectiveness against SARS-CoV-2 variants. According to Health Minister Nguyen Thanh Long, Vietnam is one of the few ASEAN countries that have candidate COVID-19 vaccines tested on human. Vietnam has been one of the first four countries to perform the gene sequencing of the SARS-CoV-2 and one of the five countries that can produce antibody diagnostic bio-products. On December 17, 2020, the first Vietnam-made COVID-19 vaccine candidate NANOCOVAX developed by Nanogen Pharmaceutical Biotechnology JSC started human trials with volunteers receiving the first doses at the Military Medical University in Hanoi. (Photo: VietnamPlus)

 The hall at the Hanoi Medical University is full of volunteers who come to register for the trials. Volunteers for COVIVAC trials will be divided into five groups, with three groups to receive vaccine  without adjuvants with three doses of 1 mcg, 3 mcg and 10 mcg, one group to receive 1-mcg dose with adjuvants and another to receive placebo. The participants will receive two shots (vaccine or placebo) and the second jab will be 28 days after the first one. The first shot is scheduled to be injected at the Hanoi Medical University in February.  Out of over 500 applicants for the vaccine trials, more than 200 underwent health check-ups, of whom 51 people were eligible for the first stage. The second stage, starting from February, is expected to conduct trials on 400-600 people aged between 2-17. (Photo: VietnamPlus)

A student reads a pamphlet on the vaccine trials. According to Prof. Dr. Ta Thanh Van, Rector of the Hanoi Medical University (HMU),  plans for phases 1 and 2 of clinical trials of the vaccine have been assessed by the ethics councils in relevant agencies. The trials will be carried out by the National Institute of Hygiene and Epidemiology together with the HMU. A center for clinical pharmacology at the university, recognised as meeting Good Clinical Research Practice (GCP), will be responsible for the process under the supervision of the Health Ministry. The pre-clinical phase has proven that the COVIVAC vaccine has many advantages, including high immunogenicity and suitability for infrastructure at vaccination facilities in Vietnam, as well as effectiveness against SARS-CoV-2 variants.  (Photo: VietnamPlus)

The trials of COVIVAC will be carried out by the National Institute of Hygiene and Epidemiology together with the HMU. A center for clinical pharmacology at the university, recognised as meeting Good Clinical Research Practice (GCP), will be responsible for the process under the supervision of the Health Ministry. Many students have registered to be injected with Vietnam’s second homegrown candidate vaccine. Last December, the Health Ministry, the Military Medical University under the Defence Ministry, and Nanogen Pharmaceutical Biotechnology JSC officially launch a project on clinical trials of Nano Covax developed by Nanogen. Twenty volunteers received the second shots of Nanocovax on January 20.   (Photo: VietnamPlus)

Dr Duong Huu Thai speaks at the ceremony to kick off the trial campaign.  He added that pre-clinical trial results showed that the candidate vaccine satisfies all conditions to be tested on humans. The vaccine candidate is being developed by IVAC and universities, research institutes and international organisations, he said, explained that it does not contain adjuvants and conservatives, and is developed with a technology of Vietnam in vaccine production which tackles seasonal influenza. He added that with completed and concerted infrastructure, 6 million doses of COVIVAC may be manufactured a year. The institute may produce about 500,000 doses per batch. (Photo: VietnamPlus).

Prof. Dr. Ta Thanh Van, Rector of the Hanoi Medical University (HMU) speaks at the event. He said that plans for phases 1 and 2 of clinical trials of the vaccine have been assessed by the ethics councils in relevant agencies. The trials will be carried out by the National Institute of Hygiene and Epidemiology together with the HMU. A center for clinical pharmacology at the university, recognised as meeting Good Clinical Research Practice (GCP), will be responsible for the process under the supervision of the Health Ministry. The pre-clinical phase has proven that the COVIVAC vaccine has many advantages, including high immunogenicity and suitability for infrastructure at vaccination facilities in Vietnam, as well as effectiveness against SARS-CoV-2 variants.  (Photo: VietnamPlus).

Experts answer questions at the launching ceremony. The hall of the Hanoi Medical University is full of students and volunteers, who register to join clinical trials of COVIVAC vaccine on humans. Volunteers for COVIVAC will be divided into five groups, with three groups to receive vaccine without adjuvants with three doses of 1 mcg, 3 mcg and 10 mcg, one group to receive 1-mcg dose with adjuvants and another to receive placebo. Volunteers will receive two shots (vaccine or placebo) and the second jab will be 28 days after the first one. The first shot is scheduled to be injected at the Hanoi Medical University in February./. (Photo: VietnamPlus)