Nguyen Sy Tuan, deputy head of the Institute of Vaccines and Medical Biologicals (IVAC) under the Ministry of Health, puts on a pair of medical gloves as he prepares to present a small bottle containing Covivac.

The second made-in-Vietnam Covid-19 vaccine successfully tested on animals is scheduled to commence human trials within the month.

Nguyen Sy Tuan, deputy head of the Institute of Vaccines and Medical Biologicals (IVAC),
holds a vial of Covivac vaccine, January 2021. Photo by VnExpress/Xuan Ngoc.

Covivac was developed using IVAC derived from the Newcastle disease virus (NDV) LaSota strain handed over by the U.S. back in May last year, routinely used as a live vaccine globally. The NDV in general is a virus that causes a deadly infection in many kinds of birds and flu-like symptoms in humans.

As targeted, the institute had to study, produce and complete a three-phase clinical trial for a Covid-19 vaccine from the strain in 18 months.

Duong Huu Thai, head of IVAC, said the process of producing the vaccine,"which is complicated, long-lasting and costly," could be divided into three phases in line with their scales: laboratory research, small-scale trial production and large-scale production.

If divided by research phase, the procedure includes creating a product, quality assessment, safety and effectiveness evaluation on animals, clinical human trial (which includes three smaller stages), registration for commercial circulation and post-licensing review.

"Yet regardless of phases etc., it normally takes around 10 years to successfully develop a vaccine," Thai said.

Producing the vaccine

IVAC decided to develop a vaccine using primary French chicken embryo cultures, a technique the institute had used in the past to successfully produce seasonal flu and H5N1 bird flu vaccines.

The NDV-Lasota vaccine strain was injected into the egg for the virus to grow before the fluid was drained for further refining and filtering. Inactivation of the virus, though with all characteristics in situ, finally produced Covivac.

The institute subsequently requested the Health Ministry's permission to commence human trials at the end of this month after completing tests on mice, rabbits and monkeys.

As planned, Covivac would enter its first phase of human trials with 125 candidates in January before the second phase starts in April, with 300 volunteers.

The third phase is currently planned for July or August but in reality, relies on results gathered from the first two phases.

Vials and boxes of Covivac, Vietnam's second Covid-19 vaccine, January 2021.
Photo by VnExpress/Xuan Ngoc.

Commenting on the institute's results, Thai said: "If we don't take the first steps, we would never arrive where we want to be. What we see now is just the beginning, there are still many challenges ahead. We are both confident and determined, based on our existing capacities."

Trials for Vietnam’s first Covid-19 vaccine, Nanocovax, began on Dec. 17 with 60 volunteers signing up for the first phase.

So far, 50-75 percent of volunteers have shown only small side effects like light fevers or pain at the time of injection, which are of no medical concern, according to experts.

The vaccine has so far been deemed safe, but whether it would be effective in preventing Covid-19 has yet to be confirmed.

Produced by Nanogen Pharmaceutical Biotechnology JSC, Nanocovax would need to undergo three human trial phases before it could be distributed.

Vietnam currently has two other Covid-19 vaccines under development by the Vaccine and Biological Production Company No. 1 (Vabiotech) and the Center for Research and Production of Vaccines and Biologicals (Polyvac).

The Health Ministry is in talks with British Covid-19 vaccine developers AstraZeneca and Oxford University to buy 30 million doses for 15 million people.

The ministry is also seeking to purchase vaccines from the U.S. (Pfizer), Russia (Sputnik V) and China.

With a population of more than 95 million, Vietnam has recorded less than 1,500 infections and 35 deaths to date.