Vietnam's second Covid-19 vaccine candidate to be tested in phase 2

Thứ Hai, 9/8/2021| 16:37

Covivac is produced by the Institute of Vaccines and Medical Biologicals under the Ministry of Health. This is the second Covid-19 vaccine candidate in Vietnam to be licensed for human testing after Nanogen Company’s Nanocovax vaccine.

The National Ethics Committee for Biomedical Research has just met to review the results of the mid-phase 1 clinical trial of the Covid-19 vaccine candidate Covivac. The test results on 120 volunteers showed that the vaccine was safe, had good immunogenicity and was accepted to be transferred to a phase 2 study.

In phase 1, Covivac had a test on 120 volunteers divided into four groups with four different doses and 20 people injected placebo.

According to the National Institute of Hygiene and Epidemiology, all four groups are safe and well tolerated. The injection process only recorded a small number of volunteers with mild pain at the injection site, while all other reactions were mild and resolved after 30 minutes.

Four groups vaccinated with Covivac vaccine all generated immunity, one group had a 10-fold increase in seroconversion compared to before injection.

The research unit, Institute of Vaccines and Medical Biologicals under Ministry of Health (Ivac) will propose a transition dose of 3 mcg for phase 2. In addition, Ivac will also add one more intermediate dose between 3 mcg and 10 mcg at this stage.

According to Dr. Duong Huu Thai, Director of the Institute of Vaccines and Medical Biologicals (Ivac), the clinical trial protocol for phase 2 of the Covid-19 Covivac vaccine candidate has been approved by the Ministry of Health from the beginning of 2021. Phase 2 of this project is expected to be deployed in Thai Binh with more than 300 volunteers.

For phase 3, the research team will develop a proposal, then consult experts and managers about it. The proposal must also be consistent with the updated recommendations of the World Health Organization (WHO) at that time.

 

Vietnam's second Covid-19 vaccine candidate to be tested in phase 2

Volunteers are injecting the experimental Covid-19 vaccine Covivac.

If the trial is successful and the vaccine candidate is licensed to use, the production capacity is currently between 20 and 30 million doses/month, Dr. Duong Huu Thai said. However, Ivac is also increasing capacity day by day, to meet the demand in case of an outbreak.

It is expected that each dose of Covivac vaccine will not exceed 60,000 VND. Ivac's highest goal is to get the best, safest and most effective vaccine to serve the prevention and control of Covid-19 in Vietnam.

Covivac uses the production technology of Newcastle vector vaccine (NDV), which binds the protein S expression gene of the SARS-CoV-2 virus with egg-based vaccine production technology. This technology is also used to produce seasonal flu vaccines in Vietnam. Covid-19 Covivac vaccine only needs to be stored at a temperature of 2-8 degrees Celsius.

The results of the preclinical studies of Covivac in India, the US and Vietnam show the safety and efficacy in the experiments. Preclinical evaluations show that the vaccine has a good immune response, is safe, and effectively prevents the variants that were first identified in the UK and South Africa.

The preclinical stage also proves that the Covivac vaccine has many advantages such as high immunogenicity, being suitable for the facilities of vaccination sites in Vietnam, as well as suitable for the variant of the SARS-CoV-2 virus.

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