Vietnam’s Ministry of Health will set up a national institute on vaccine production and technology transfer following a request made by Deputy Prime Minister Vu Duc Dam who is also head of the National Standing Committee for Covid-19 Prevention and Control.
|Inside Nanogen Pharmaceutical Biotechnology JSC (Nanogen)'s Covid-19 vaccine plant. Photo: VnExpress|
The institute will be tasked with facilitating vaccine production projects, especially Covid-19 vaccines.
With the operation of the national institute, projects on Covid-19 vaccine research and development will receive up to 100% financial support.
Concerning the development of homegrown Covid-19 vaccines, Vietnam’s top leaders have urged relevant agencies to facilitate the process.
The country is home to four domestic Covid-19 vaccine candidates developed by Nanogen Pharmaceutical Biotechnology JSC (Nanogen), the Institute of Vaccines and Medical Biologicals (IVAC), the Vaccine and Biological Production Company No.1 (VABIOTECH), and the Center for Research and Production of Vaccines and Biologicals (POLYVAC).
Of them, Nanogen will finish its Nanocovax vaccine's mid-August phase 3 of clinical trials domestically with around 13,000 volunteers aged between 18 and 75. Meanwhile, Covivac by IVAC is on phase 2 clinical trials.
Earlier, Prime Minister Pham Minh Chinh encouraged the development of domestic Covid-19 vaccine candidates and set a deadline for the rollout in June 2022.
Deputy Health Minister Tran Van Thuan on July 17 said Vietnam might have its own Covid-19 vaccine at the end of 2021.
Regarding vaccine production capacity, 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 is a national regulatory agency responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines) are evaluated properly and meet international standards of quality and safety.
NRA this year moved to one level in the World Health Organization (WHO)’s rating scale for the safety and efficacy of vaccines.
With the certificate granted in 2015, vaccines used by the national immunization program are certified safe and effective. All vaccines under Vietnam’s national Expanded Program on Immunization (EPI) are free of charge, without shortage of supply, available at commune health centers across Vietnam, according to WHO Vietnam.
With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in Vietnam are now eligible to apply for WHO prequalification of specific products.
So far, Vietnam has produced and exported 11 kinds of vaccines against 11 diseases in the 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.