Researching embryonated chicken eggs for vaccine production at a facility of the Institute of Vaccines and Medical Biologicals, which is also developing a COVID-19 vaccine based on its existing flu vaccine manufacturing process.(Photo: VNA) Classification is carried out by WHO’s Global Benchmarking Tool (GBT) whichassesses a number of functions and criteria to ensure the quality, safety, andeffectiveness of vaccines distributed in the country.
In April 2015, Vietnam’s vaccine regulatory authorities achieved the“Functional” status against WHO Vaccine Assessment Tool.
In 2018 November, a WHO team comprising of international experts re-assessed Vietnam’sNRA using an updated and more comprehensive GBT (version V) with new functionsand benchmarking criteria.
It requires national regulatory authorities, including those who have beencertified by WHO in 2015, to make great efforts to further improve theirsystems.
GBT evaluation results are presented as maturity levels on a scale of 1 to 4.Achieving Maturity Level 1 means some elements of regulatory system exist.Maturity Level 2 indicates evolving national regulatory system that partiallyperforms essential regulatory functions. Maturity Level 3 confirms a stable,well-functioning and integrated regulatory system is in place. The highestlevel, Maturity Level 4, is achieved by a regulatory system operating atadvanced level of performance and continuous improvement.
Vietnam’s NRA for vaccines has been maintained and enhanced in recent years tomeet the domestic demand including vaccines in the National Expanded Programme onImmunisation, as well as to be the trusted authorisation body so that domesticvaccines could be exported to other countries, contributing to the regional andglobal supply of vaccines.
During the latest evaluation, Maturity Level 3 was certified to NRA forvaccines in eight of the nine functions of regulating vaccines. Acceleratedefforts are continuing to expand NRA maturity to medicines and other medicalproducts.
Dr. Kidong Park, WHO Representative in Vietnam, congratulated the country onthis achievement.
“This accomplishment reaffirms the continuous collaboration between theGovernment of Vietnam and WHO in achieving universal access to safe, effectiveand affordable vaccines,” he said.
“It is expected that the country’s regulatory system for medicines, vaccinesand other medical products will transform further to become a more coherent andscience-based national regulatory authority independent from political andcommercial influence.”
Currently, Vietnam has managed to produce 11 vaccines to prevent 11 diseasescovered under the expanded immunisation programme (tuberculosis, diphtheria,pertussis/whooping cough, tetanus, hepatitis B, Japanese encephalitis, cholera,typhoid, measles, rubella, poliomyelitis), in addition to other types ofvaccines like seasonal flu, H5N1 influenza, and rotavirus.
Four Vietnamese vaccine manufacturers and developers are researching locallymade COVID-19 vaccines, with two – Nano Covax by HCM City-based pharmaceuticalcompany Nanogen and COVIVAC by the Institute of Vaccines and MedicalBiologicals – already in human trials.
The frontrunner in the race, Nano Covax, is expected to obtain a licence forcirculation within 2021./.
VNA
