Vietnam will provide investors with financial support and preferential treatment in vaccine development, including Covid vaccines.
Businesses and organizations engaging in the development of vaccines against the pandemic would get 100% financial assistance for exploratory stage, clinical trials, manufacturing, and quality control, according to a decision signed early this month by Deputy Prime Minister Vu Duc Dam.
In the national vaccine production by 2030 program, volunteers participating in the trials would also receive financial support.
The maximum support will apply to both research and technology transfer of vaccine production.
Vietnam will focus on advanced technology-based vaccine production namely mRNA (like the one applied for the production of Pfizer and Moderna); recombinant vaccines; and viral vector vaccines.
In addition to Covid-19 vaccines, Vietnam is expected to produce vaccines against cancers.
To make the goals possible, the country will prioritize the purchase of patents and hire foreign experts to support the research and development of vaccines.
In a broader move, the government targets to produce at least three kinds of vaccines and acquire tech transfer of 10 others by 2025, five and 15, respectively in 2030.
The vaccines will serve the country’s immunization programs and export.
Inside a plant producing Covid-19 vaccine. Photo: Khanh Huy/ The Hanoi Times. |
Covid-19 vaccine candidates
Currently, Vietnam has two homegrown Covid-19 vaccine candidates, namely Nanocovax developed by Nanogen Pharmaceutical Biotechnology JSC and Covivac by Nanogen Pharmaceutical Biotechnology JSC (IVAC).
Three others under development are those of tech transfer, including ARCT-154 Covid-19 vaccine, or known as VBC-COV19-154 in Vietnam, signed between Vingroup and US Arcturus Therapeutics; recombinant DNA technology-based vaccine to be transferred to Vietnamese Vaccine and Biological Production Company No.1 (VABIOTECH) by Japanese Shionogi & Co., Ltd; and recombinant adenovirus-based Sputnik V vaccine thanks to the collaboration between VIABIOTECH and the Russian Direct Investment Fund (RDIF).
Homegrown Nanocovax vaccine has entered phase 3 clinical trials while Covivac is on phase 2 trials.
At present, the Translational Health Science and Technology Institute (THSTI) under India’s Ministry of Science and Technology is conducting tests on peripheral blood mononuclear cells (PBMC) of people who got Nanocovax doses to access the immunogenicity of the DNA-based vaccine. Results from such assessment would provide critical inputs to seek Vietnam’s authorization for emergency use of Nanocovax.
Nanocovax’s phase 3 clinical trials have involved around 13,000 volunteers. The producer has proposed the government to approve the vaccine for emergency use. However, the Ministry of Health said they need more evidence on its effectiveness.
Vaccination and recovery
Developing Covid-19 vaccines is crucial for Vietnam in conducting its recovery plans after it got a significant impact by the months-long outbreak.
Vietnam’s vaccine production plan becomes ambitious with concrete roadmaps for other kinds of vaccines, with efforts to join the global vaccine supply chain and enhance its countering capability in future pandemics, and achieve strategic goals.
Regarding vaccine production ability, Vietnam was certified to have a fully-equipped national regulatory system for vaccine regulation in 2015.
The certificate means that Vietnam’s National Regulatory Authority (NRA) is compliant in all areas required to provide regulatory oversight of vaccines: overall system framework; marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials.
NRA indicates the World Health Organization (WHO)’s rating scale for the safety and efficacy of vaccines.
So far, Vietnam has produced 11 kinds of vaccines against 11 diseases in the Expanded Program on Immunization (EPI), namely TB, diphtheria, pertussis, tetanus, hepatitis B, Japanese encephalitis, cholera, typhoid, measles, rubella, and polio. It has also made different kinds of vaccines against seasonal flu, H5N1, and Rotavirus.