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)Hanoi (VNS/VNA) – The World Health Organisation (WHO) has recently
announced that Vietnam’s National Regulatory Authority (NRA) for vaccines
reached Maturity Level 3, the second highest in the WHO classification of
national regulatory system.
Classification is carried out by WHO’s Global Benchmarking Tool (GBT) which
assesses a number of functions and criteria to ensure the quality, safety, and
effectiveness 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’s
NRA using an updated and more comprehensive GBT (version V) with new functions
and .
It requires national regulatory authorities, including those have been
certified by WHO in 2015, to make great efforts to further improve their
systems.
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 that partially
performs essential regulatory functions. Maturity Level 3 confirms a stable,
well-functioning and integrated regulatory system is in place. The highest
level, Maturity Level 4, is achieved by a regulatory system operating at
advanced level of performance and continuous improvement.
Vietnam’s NRA for vaccines has been maintained and enhanced in recent years to
meet the domestic demand including vaccines in the National Expanded Programme on
Immunisation, as well as to be the trusted authorisation body so that domestic
vaccines could be exported to other countries, contributing to the regional and
global supply of vaccines.
During the latest evaluation, Maturity Level 3 was certified to NRA for
vaccines in eight of the nine functions of regulating vaccines. Accelerated
efforts are continuing to expand NRA maturity to medicines and other medical
products.
Dr. Kidong Park, WHO Representative in Vietnam, congratulated the country on
this achievement.
“This accomplishment reaffirms the continuous collaboration between the
Government of Vietnam and WHO in achieving universal access to safe, effective
and affordable vaccines,” he said.
“It is expected that the country’s regulatory system for medicines, vaccines
and other medical products will transform further to become a more coherent and
science-based national regulatory authority independent from political and
commercial influence.”
Currently, Vietnam has managed to produce 11 vaccines to prevent 11 diseases
covered 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 of
vaccines like seasonal flu, H5N1 influenza, and rotavirus.
Four Vietnamese vaccine manufacturers and developers are researching locally
made COVID-19 vaccines, with two – Nano Covax by HCM City-based pharmaceutical
company Nanogen and COVIVAC by the Institute of Vaccines and Medical
Biologicals – already in human trials.
The frontrunner in the race, Nano Covax, is expected to obtain a licence for
circulation within 2021./.
Source: VietnamPlus
