A World Health Organization (WHO) representative has underlined the responsibility of vaccine producers’ in upholding data transparency as a domestic company is urging the government to approve its jab for emergency use in Vietnam without finishing late-stage clinical trials.
Dr. Park Ki-dong – WHO Representative in Vietnam – sat down for an interview with Tuoi Tre News on Tuesday, at a time when Ho Chi Minh City was implementing its biggest-ever vaccination drive to contain a major COVID-19 resurgence that has been ongoing since late April.
Vietnam has documented over 13,000 local infections in 50 out of its 63 provinces and cities since April 27, when the pandemic's fourth wave erupted, including more than 3,700 cases in the business hub Ho Chi Minh City.
These figures are multiple times those recorded in the previous rounds. The country now adds hundreds of patients on a daily basis.
On the request of Nanogen Pharmaceutical Biotechnology JSC, a local company, for the Vietnamese Ministry of Health's approval of its Nano Covax vaccine for emergency use, Dr. Park warned authorities to review related data carefully to align with national regulations and legislation.
He also aired opinions on Ho Chi Minh City’s recent measures to combat COVID-19, emphasizing that vaccine is not a silver bullet.
Regarding the request to validate Vietnam’s homegrown COVID-19 vaccine Nano Covax for emergency use, the Ministry of Health thinks that it is "hasty, as there is not enough scientific data.'' What is the opinion of WHO about this statement? What conditions must be met for a vaccine to be approved for emergency use?
To date, a number of COVID-19 vaccine products have already been approved for WHO emergency use listing and used in mass vaccinations in many countries.
However, the speed of development does not mean that these vaccines were approved by skipping essential steps of testing and evaluation.
Any vaccine should go through a rigorous evaluation process of efficacy, quality, and safety through multiple steps of assessment including pre-clinical assessment and three phases of clinical trials.
Even for emergency use approval such as for COVID-19 vaccine, all critical steps and necessary criteria should not be skipped.
As of June 25, 2021, 184 vaccines are under pre-clinical development and another 104 vaccines are under clinical assessment stage of development globally.
We understand Nano Covax has just entered clinical trial phase 3. In principle, the manufacturer should generate sufficient scientific data on efficacy, quality, and safety from these clinical trials. The national regulatory authority should review the data carefully once available, in line with the national regulations and legislation.
To support manufacturers and national regulatory authorities in this unprecedented situation, WHO has published documents and guides on clinical evaluation and evaluation standards for COVID-19 vaccines that governments can use as the basis for their own regulatory guidelines.
Currently, some countries around the world, for example Cuba, have administered new vaccine shots in large-scale phase 3 trials as part of their intervention studies on how effective they are in preventing and stopping the spread of the respiratory disease. What should be noted if Vietnam wants to apply similar measures to its domestic COVID-19 vaccines?
The clinical trial phase 3 is usually done on a large scale with more than several thousand participants at multiple study centers before vaccine usage by the public. The study design should be well-developed, reviewed, and approved by a research ethics committee as well as the National Regulatory Authority (NRA) of the country where the trial is conducted.
For COVID-19 vaccines, there are instances where a country may decide on some exceptional ways to address the unprecedented need to control the disease. However, alternative options should be based on careful risk and benefit assessment in the country, and be carefully planned with ethical considerations together with risk management. They should not compromise the critical requirements and evaluation criteria to ensure the safety, quality, and efficacy of a vaccine.
The COVID-19 situation in Ho Chi Minh City is getting complicated. What are WHO’s recommendations for the city to curb the pandemic?
Vaccines could be an effective tool to fight this pandemic in the long run. But the role of vaccines in acute outbreak control settings is limited. Most vaccines require two shots and a few weeks after the second shot to protect people. Social distancing, combined with vaccine, is the right approach.
The Vietnamese government has been working proactively together with international partners to secure more vaccines for the country and to ensure its equitable access to everyone.
The government has reinforced the robust outbreak response actions that have proven to work. These include the four-on-the-spot approach (human resources – facilities – response actions – resources) and five-principle strategy (prevention – early detection – quarantine – zoning – stamping out outbreaks).
We understand that the Ho Chi Minh City People’s Committee has directed the health system to increase the testing capacity up to 500,000 samples per day and health workers have been working round the clock. The committee has been decisive in directing public health measures, including the issuance of its own Directive No. 10 to guide social distancing measures to be applied. We need our people to once again show solidarity and compliance to health measures.