This information was shared by Nguyen Ngo Quang, Deputy Head of the Administration of Science, Technology and Training under the Ministry of Health (MoH), on the sidelines of a recent workshop on speeding up the research into and production of a vaccine against COVID-19.
According to Quang, on the basis of emergency guidance, especially from the United States and the European Union, the MoH is finalising guidelines and processes on the appraisal and approval of the clinical trialling, testing and licencing of COVID-19 vaccines in case of emergency.
Basically, these processes are to be implemented in accordance with general international guidelines based on the principle of ensuring scientific, ethical and time-based requirements to ensure the safety and effectiveness of the products and the protection of people's health.
Accordingly, in terms of the appraisal process, it is expected to shorten the time for appraisal from about two months to 10 days.
Regarding the research process, there will also be appropriate adjustments. Previously, the average expected time was from 3-5 years for a vaccine clinical trial study, but this period may now be shortened whilst still following the scientific and ethical requirements for any possible COVID-19 vaccines, Quang stated.
During the implementation process, the ministry’s relevant functional departments and testing institutes will participate in the research process to shorten the time for the vaccines to ensure adherence to the schedule as directed by the Prime Minister.
Nguyen Ngo Quang, Deputy Head of the Administration of Science, Technology and Training under the Ministry of Health.
Quang affirmed that following this approach, by October next year, Vietnam is likely to have a vaccine against COVID-19 with both its safety and effectiveness assured.
Currently, four domestic manufacturers and research agencies are focusing on the production of possible COVID-19 vaccines. Each is following a different direction, but all have gained initial positive results.
The Institute of Vaccines and Medical Biologicals (Ivac), using the existing technology of chicken eggs with embryos to produce the A/H5N1 influenza vaccine with a capacity of 3 million doses per year, is boosting the application of the technology towards a possible COVID-19 vaccine.
Ivac’s Head Duong Huu Thai said that this July, his institute has produced a batch for pre-clinical evaluation, thereafter appraising and optimising the production process. It is expected that between October and December this year, the institute will conduct the first clinical trials on humans, followed by the next two stages in early 2021, thereafter upgrading capacity to 30 million doses a year. By May 2021, the unit will apply for a licence.
The Vaccine and Biological Production No.1 Company (Vabiotech) has conducted preclinical research trials on mice with very satisfactory results and good immune responses. Vabiotech Director Do Tuan Dat said that his company is using baculovirus vector technology in the development of its COVID-19 vaccine. Vabiotech is currently in the process of developing strains/cell-lines on an industrial scale. This month, it will boost production of the strains at a GMP scale.
It addition to the two above units, the Centre for Research and Production of Vaccines and Biology (Polyvac) is using recombinant technology on the measles virus vector to produce a possible COVID-19 vaccine. Meanwhile, Nanogen Biopharma has also been successful in studying a subunit candidate vaccine based on the Spike (S) protein of the SARS-CoV-2 virus, currently being tested for its immune response in mice.
Prof., Dr. Nguyen Thanh Long, Acting Minister of Health.
Prof., Dr. Nguyen Thanh Long, Acting Minister of Health, said that the ministry encourages all agencies, even those that have never produced vaccines, and is creating favourable conditions for them to participate in vaccine research and production.
For units that have gained good results, the MoH is ready to support and facilitate them with investment as well as shortening the time for the required procedures. “We emphasise that we will not only reform and abolish certain administrative procedures but that other procedures related to scientific and professional requirements will be safeguarded to fulfil the safety and effectiveness of the vaccines,” said Long.
Regarding testing, Vietnam currently has three testing centres nationwide. The country is willing to participate and collaborate with international community to test the vaccines on a global scale.
"We expect that by the end of 2021 there will be a COVID-19 vaccine for the Vietnamese people," Long said.