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Vietnam and Covid-19 vaccine production

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As of August 8, 2021, some 4.4 billion doses of Covid-19 vaccines have been administered in 180 countries and territories in the world. All in all, around 30% of the global population have been inoculated with one dose and 15% with two doses. However, the distribution of vaccines is uneven in different parts of the globe. In poor countries, the ratio of people receiving one jab is only 1.1%. Approximately, 8.3% of all Vietnamese have received one shot and 0.9% received two. COVAX, Covid-19 Vaccine Global Access, a global initiative aiming at equitable access to Covid-19 vaccines, has so far been able to provide only 188 million doses in 138 countries, way below the target of 2 billion doses in 2021. Therefore, Vietnam should try her utmost to produce vaccines on her own. This article addresses some aspects of the issue.

Vietnam has gained considerable experience in producing common vaccines, having been able to produce 10 out of the 11 vaccines used in the global Expanded Program on Immunization (EPI). The country can conduct studies and production of vaccines against seasonal flu (A/H1N1, A/H3N2 and B strains) and the dangerous A/H5N1 bird flu.

In 2015, the National Regulatory Authority of Vietnam (NRA) was certified by the World Health Organization (WHO) as meeting international standards for vaccine regulation, which means that vaccines recognized by the NRA are considered safe and effective. Four agencies under the Ministry of Health can do this job, including the Drug Administration of Vietnam, the Administration of Science, Technology and Training, the National Institute for Control of Vaccines and Biologicals and the Vietnam General Department of Preventive Medicine.

In April this year, WHO raised Vietnam’s NRA to Maturity Level 3 (ML3), which ranks Vietnam among the 50 countries in the world attaining either ML3 or ML4. At this level,

Covid-19 vaccines made in Vietnam can be included in the list to be applied for WHO evaluation and recognition.

Now in Vietnam, seven Covid-19 vaccines which are being studied or whose technologies are bought from abroad by Vietnamese pharmaceutical firms are in the clinical trials or about to be mass-produced.

Vabiotech in cooperation with Russian Direct Investment Fund (RDIF) has produced and packaged 30,000 doses of Sputnik V vaccine from semi-finished products. Samples of this batch have been sent to Gamaleya Institute in Russia, where the vaccine was invented, for certification with the viral vector technology. If the samples are qualified, Vabiotech will engage in sub-contracting Sputnik V vaccine. As this vaccine was recognized by the Ministry of Health in March, it can be put into use immediately. RDIF will transfer Sputnik V production technology to Vabiotech.

Nanocovax developed by Nanogen using the recombinant protein technology is in phase 3 of the clinical trials. This vaccine is being tested in two forms, injectable and inhalable. A preliminary report of phase 3a was to come out prior to August 15 so that the Research Ethics Committee can appraise the vaccine’s effectiveness. If things go smoothly, the vaccine can be licensed to have emergency use authorization.

Vinbiocare, a subsidiary of Vingroup, which was set up in June, has concluded a deal with the U.S.-based Arcturus for the purchase of the technology for producing ARCT-154 vaccine (renamed VBC-Covid-19-154). This vaccine employs the innovative technology saRNA (self-assembling RNA), which is similar to the mRNA technology but can self-multiply and thus its immunity is expected to last longer. ARCT-154 has gone through phases 1 and 2 in the United States and Singapore. Vinbiocare plans to conduct phase 3 of the clinical trials in the near future.

Covivac, a vaccine developed by the Institute for Vaccines and Medical Biologicals (IVAC) using the vector technology and fertilized egg-based technology, is transferring from phase 1 to phase 2 of the clinical trials. As this vaccine uses traditional technologies, Vietnam has sufficient experience in such production.

Another Covid-19 vaccine of Vabiotech in cooperation with Bristol University (the United Kingdom) employs the protein subunit technology and is in phase 1 of the clinical trials.

In addition, Vabiotech together with Advanced International Joint Stock company (AIC) is said to have signed a contract according to which Shionogi of Japan would transfer the technology for producing a vaccine using the recombinant protein technology. Shionogi’s vaccine has undergone phases 1 and 2 of the clinical trials in Japan.

IVAC has also been reported to have discussed with the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba for the technological transfer of the latter’s Abdala vaccine, which has undergone all the three phases of the clinical trials. According to CIGB, this vaccine making use of the protein subunit technology has reached an efficiency rate of 92% after three jabs and has been recognized by Cuba.

Therefore, from now to the end of the year, at least one made-in-Vietnam vaccine will emerge. This is an encouraging step which helps Vietnam be more proactive in supplying herself with vaccines to fulfill her goals of immunizing her population. However, some issues need to be tackled.

First, as most of the above vaccines are in the clinical study and have yet to be officially recognized, the related authorities should conduct careful checks and appraisal so that the vaccines can be recognized. When it comes to the mRNA or saRNA technology, which Vietnam has yet to acquire expertise, even more care should be taken.

Generally speaking, Vietnam should focus on technological transfer of vaccines which have been recognized by the WHO or developed countries. These vaccines have built their trust in terms of safety and efficiency, which can spare Vietnam from having to take time to do the clinical trials. In the current context of the ongoing pandemic, it matters much to quickly put into use the most reliable vaccines.

Eventually, some countries that have purchased foreign vaccine technology have faced technological problems in producing the vaccines regarding technology and input material supplies. A case in point is Siam Bioscience of Thailand. As this firm has no experience in vaccine production, it was faced with difficulties in the supply chain and failed to comply with its schedule for producing AstraZeneca vaccine.

To sum up, Vietnam has the potential for studying and producing Covid-19 vaccines. After being certified by competent Vietnamese health authorities, the vaccines can be filed for recognition by the WHO for emergency use. By doing so, Vietnamese vaccines may gain credibility and be exported. Such steps will be of great help to the fight against the coronavirus and other epidemics in the future in line with the program to produce vaccines against diseases by 2030 by the Ministry of Science and Technology. In addition, this is a way to turn the local industry of vaccines and biologicals into a promising sector.

By Tran Quoc Hung(*)

(*) A U.S.-based economist

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