Vaccines are a decisive factor in long-term strategies for the prevention and control of infectious diseases, including COVID-19. Actively researching and developing homegrown vaccines is a very important requirement in ensuring social security and safety for Vietnamese people.

In mid-2020, when the COVID-19 epidemic was still unfamiliar to the world, several major pharmaceutical companies in the world announced that they were embarking on the development of a vaccine against the disease.

In Vietnam, four local vaccine manufacturers also announced their participation in this journey, including Nanogen Pharmaceutical Biotechnology JSC, Company for Vaccine and Biological Production No.1 (Vabiotech), Nha Trang Institute of Vaccines and Medical Biologicals (IVAC), and the Centre for Research and Production of Vaccines and Biologicals (POLYVAC).

At that time, few would think that just one year later, two among of the above four units would have their vaccines in the human trial stage, with the Nano Covax vaccine of Nanogen Company having entered phase 3 trials on human, and IVAC's Covivac vaccine having completed its phase 1 of human trials.

Normally, developing a vaccine takes 5-10 years. Vietnam has been involved in vaccine production since the 1960s, with the National Expanded Programme on Immunisation using most locally made vaccines. But with a new disease like COVID-19, will the race for a domestic vaccine keep up with the world’s pace and the local need? And the answer after more than a year is: the hope of a Vietnamese vaccine against COVID-19 is closer than ever.

Promising hope for a made-in-Vietnam COVID-19 vaccine

Before launching the phase 3 of human trial in mid-June 2021, Lieutenant General, Professor, Dr. Do Quyet, Director of the Vietnam Military Medical Academy, the unit that is deploying the Nano Covax vaccine trial on humans, shared that he was very grateful for the volunteers who participated in the vaccine trial, because without them, there would be no vaccine.

Nano Covax vaccine is developed based on recombinant DNA/protein technology, which is new compared to the vaccine production level in Vietnam. At the initial stage, this project was not with the best development progress. But then the vaccine "race" heated up, and the progress of the vaccine manufacturing accelerated. In July and August 2020, two local units sent vaccine samples tested on animals for evaluation abroad.

At that time, any information related to the vaccine progress and how effective is the test on mice and the difficulties during the vaccine race was all important news, with the dream of a locally made vaccine drawing closer.

 Deputy Prime Minister Vu Duc Dam is one of the volunteers in the trials of Nano Covax.

At the end of 2020, the Ministry of Health allowed Nano Covax to deploy testing on humans. On December 17, 2020, the first trial injection was started on three volunteers at the Hanoi-based Military Medical University, then being expanded to a small group, with only a few people injected a day, using each dose of 25mcg, 50mcg and 75mcg.

In late February 2021, Nano Covax entered phase 2 of human trials and in mid-June it moved to phase 3. If all goes well, after 42 days of injecting the first dose to the first 1,000 people out of 13,000 people in phase 3, around September, the research team will complete data collection for manufacturers to submit dossiers that will kickstart the process of asking the Ministry of Health to approve the vaccine under the form of "a state of emergency during the pandemic".

Vietnamese vaccines for Vietnamese people

According to Prof., Dr. Do Quyet, with a very urgent and serious, scientific progress, the clinical trial of the Nano Covax vaccine has been licensed by the Ministry of Health for phase 3 and started injecting for volunteers from June 10. The third-phase trials, using only the 25mcg doses, covers 13,000 volunteers aged between 18 and 75 nationwide.

The goal of phase 3 is to assess the safety of the vaccine, how high or low humoral immunity (antibodies) is, and how effective the vaccine is for the communities that are hit by the epidemic. Researchers closely evaluate the criteria of immunity: humoral immunity, cellular immunity, and the effect of the vaccine against the SARS-CoV-2 virus different strains, including the Delta variant.

The goal of phase 3 is to assess how effective the vaccine is for the communities that are hit by the epidemic.

In late July, research centres began the injection of the second shots of COVID-19 Nano Covax vaccine for 12,000 volunteers, while the mid-term assessment for the test results on the first 1,000 volunteers injected with the first dose is expected around the end of the third quarter or at the beginning of the fourth quarter this year (42 days after the first injection).

If the epidemic is complicated amid the shortage of vaccine supplies, manufacturers would submit it to the Ministry of Health and other concerned authorities for an emergency license of Nano Covax vaccine to inject the community.

Meanwhile, the phase 3 is continuing as planned (injection and monitoring 13,000 volunteers; 1,000 people in phase 3A continue to be monitored after 42 days since the first shot) even though the vaccine has been licensed.

According to Quyet, the Nano Covax vaccine has just been deployed in phase 3, so there is not enough information needed to fully evaluate its advantages and limitations. However, up to now, the vaccine is safe, has few side effects, and has high immunogenicity.

 Up to now, the [Nano Covax] vaccine is safe, has few side effects, and has high immunogenicity. 

Professor Do Quyet
Vietnam Military Medical Academy

In phase 2 of the clinical trial, after 42 days of injection, the antibody titer ratio differed by tens, hundreds of times compared to the time before injection. Currently, initial results in phase 3 after the first injection also showed that the vaccine is quite safe.

Through phase 1 and 2 with injections on 620 people since late December 2020 until now, the Nano Covax research team said that in phase 1, the vaccine was injected into 60 people, at three doses of 25, 50 and 75mcg. The safety level of the vaccine shows that it meets the safety requirements.

In phase 2, over 560 people were injected, with three groups of doses of 25, 50, 75mcg and a group receiving placebo, with the oldest person injected being 77 years old. The results also showed that the immunogenic effect of the vaccine gradually increased post-injection and the highest is on the 42nd day after the 1st injection (14 days after the injection of the second dose).

Regarding the safety level, assessed through the rate of people experiencing adverse reactions after injection, the results showed that after the first injection, 2.5% had pain at the injection site (with 3.4% recorded in the 2nd dose).

 Vaccine research at Nanogen

Similarly, there were 2.7% showing signs of sensitivity at the injection site (after 2nd injection, the rate was 3.2%). There was 0.2% having redness at the injection site (0.5% after 2nd injection), while other reactions such as pruritus at injection site, myalgia and fatigue were trivial or under 1%. Among 560 injections, only one person had diarrhoea after the first injection, and one had a grade 4 (mild) anaphylactic reaction after the injection.

From these parameters, the research team submitted to the Ministry of Health an injection outline of 25 mcg, each person injecting two doses 28 days apart, in phase 3.

It is expected that in the next two months, initial data of phase 3 will be submitted to the Ministry of Health, while continuing to inject and monitor 12,000 people participating in the trial.

 Prime Minister Pham Minh Chinh visits Nanogen, the producer of Nano Covax.

Meanwhile, regarding the Covivac vaccine, Nguyen Ngo Quang, Deputy Head of the Health Ministry's Department for Science, Technology and Training, announced that Covivac also started phase 1 of human trials at the beginning of March 2021. The initial data shows that the vaccine is safe.

According to Dr. Duong Huu Thai, Director of the Institute of Vaccines and Medical Biologicals (IVAC), since the launch of phase 1 clinical trials (from March 15), the COVID-19 Covivac vaccine has been eligible for evaluation for safety and immunogenicity. Initial evaluation shows that Covivac has good results and is expected to become a vaccine for the prevention of COVID-19 in Vietnam.

 Our initial assessment is that the Covivac vaccine is safe and produces quite good immunity. 

Dr Duong Huu Thai
Institute of Vaccines and Medical Biologicals

After the 2nd injection, 120 volunteers participating in the phase 1 trial were in good and stable health, with a few having experienced very mild side effects such as pain or swelling in the injection area. No one had severe reactions.

“This rate is very small, occurs in only a few people and the reaction is also mild. The rest had no severe reactions. Our initial assessment is that the Covivac vaccine is safe and produces quite good immunity," said Thai. The research team has developed a mid-term report to move from phase 1 to phase 2.

According to Thai, the clinical trial protocol of phase 2 of COVID-19 Covivac vaccine has been approved by the Ministry of Health from the beginning of 2021. This phase is expected to be deployed in Thai Binh Province with more than 300 volunteers to receive their first injection in late July or at the beginning of August. It is expected to end by late September or early October before the results to be reported to the Ministry of Health.

For phase 3, around August, the research team will develop a proposal, then consult experts and managers on it to make the proposal a scientific and safe one, in accordance with regulations, with procedures handled in the shortest time but must be consistent with the updated recommendations of the World Health Organisation (WHO).

 A volunteer is given a shot of the Covivac vaccine.

“If all goes well, we could have a vaccine product for emergency use (when licensed) by the end of 2021 or in early 2022. This is also the case that must be licensed by the Ministry of Health for emergency use. As we have seen, most of the vaccines in the world are currently licensed for emergency. Therefore, IVAC will certainly also look to the case to apply for an emergency license," said Thai.

It is expected that each dose of Covivac vaccine should not exceed VND60,000. 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 is the second COVID-19 vaccine candidate in Vietnam to be licensed for human trials, after the Nano Covax vaccine of Nanogen Company.

Meanwhile, Vabiotech Company is also testing the ability to prevent the South Africa’s coronavirus variant – the virus strain is developing in the direction of limiting the effectiveness of the COVID-19 vaccines. This is the third candidate vaccine from Vietnam.

 Along with the current vaccine strategy and Vietnam’s past achievements, I believe that Vietnam is really an attractive destination. This certainly has not changed. 

Dr Daniel Borer
RMIT University Vietnam

Pointing to a special point in Vietnam's vaccine strategy and the opportunity to recover even during the pandemic, Dr. Daniel Borer, a RMIT Vietnam professor with a PhD in international banking and a master's degree in leadership and strategy, said that: "Along with the current vaccine strategy and Vietnam’s past achievements, I believe that Vietnam is really an attractive destination. This certainly has not changed."

Regarding Vietnam's vaccine autonomy (self-production) strategy, it is true that vaccine development requires a lot of time and cannot be done quickly. However, as WHO has shared, the coronavirus is constantly mutating to create new variants. Therefore, the fact that Vietnam is self-sufficient in vaccine sources is very good in the fight against the disease, even in the long term.

On average, the time to develop a COVID-19 vaccine lasts about 1.5 years, an unprecedented progress for any Vietnam's vaccine, and this is also a significant step forward because so far, many countries with more advanced technologies than Vietnam are still struggling to find vaccine sources.

According to the Ministry of Health, Vietnam has accessed about 120 million doses of COVID-19 vaccine, but so far it has only received about 2.8 million doses and another 5 million doses at the end of July, just enough for about 12% of the population with vaccination indications. Without enough vaccinations, it will be very difficult to return to a normal life.

The Ministry of Health also shared that vaccine suppliers all have commitments on the number of vaccines to be supplied to Vietnam soon, but they also informed that the quantity and supply time may depend on the epidemic situation and suppliers’ capabilities.

Vietnam needs about 150 million doses of COVID-19 vaccines in 2021, and compared with commitments secured so far, it is likely that there will not be enough until 2022.

However, with the promising progress on several homegrown vaccines, especially the Nano Covax COVID-19 vaccine, a made-in-Vietnam vaccine is approaching.