What Vietnam Needs to Produce Licensed Covid Vaccines

Professor Thomas Preiss of the John Curtin School of Medical Research, Australian National University, said mRNA vaccine production is a new technology and involves several distinct steps.

Preiss said mRNA is the basis of some Covid vaccines like those made by Pfizer-BioNTech and Moderna, while AstraZeneca uses viral vector technology.

He said the more conventional AstraZeneca vaccine could likely be made by an appropriately sized Vietnam-based vaccine producer. The implementation of the new technology for the production of mRNA would be more complex but still feasible. The country does not need to build a huge factory to make mRNA vaccines, and only needs several full-size clean rooms in which most of the processes could be carried out, he said.

A health worker at the HCMC Tropical Disease Hospital holds a dose of AstraZeneca vaccine in March 2021. Photo by VnExpress / Huu Khoa.

Regardless of the type of vaccine, “Vietnam will need to build facilities that meet high medical manufacturing standards to make an effective and safe Covid-19 vaccine.”

For Vietnam to have an end-to-end solution for mRNA production, it would take a facility to make the gmp grade DNA plasmid and a specialized bioreactor for making the real mRNA using that DNA as a template. and purify it. Another specialized device will take the purified mRNA and package it into lipid nanoparticles. Finally, the formulated mRNA vaccine should be distributed in ampoules and packaged for shipment. This last “filling and finishing” step is similar for any type of vaccine.

In producing any vaccine, there are multiple issues that a country must address, such as having the facilities, raw materials and supply lines, said Preiss. In addition, the patent regime for mRNA vaccines involves several sub-steps that are patented separately, he said. Licenses should be sought from several entities.

If Vietnam is to manufacture the mRNA vaccine, it must also procure a number of specific types of building blocks and other reaction components. The supply lines are different from those that manufacture the AstraZeneca vaccine in terms of production and packaging.

Citing the case of Australia, which already makes the AstraZeneca vaccine, he said a large pharmaceutical company had tweaked its existing plant for production. As the mRNA vaccine is based on new technology, there are currently no established manufacturing lines in Australia, but the government has just started a market approach process to encourage commercial parties to establish a production facility for the vaccine. Sovereign mRNA for the country.

Preiss said Vietnam is not beyond Vietnam’s capacity to produce vaccines, and if it is ambitious about developing its biotech industry, establishing mRNA production could be a good idea. thing.

It is not too complex for a developing country to manufacture vaccines, even mRNA vaccines, if it has the resources, he said, stressing that India, a developing country, is the world’s largest vaccine manufacturer.

On May 14, the World Health Organization (WHO) said it was considering a proposal from an unidentified Vietnamese vaccine manufacturer to make a Covid-19 vaccine based on mRNA.

Vietnam last week asked the UK to consider transferring vaccine technologies to Vietnam.

Nitin Kapoor, chairman and chief executive of AstraZeneca Vietnam, said the company would consider transferring the technology to Vietnam in the future if there is a partner in the country capable of producing drugs, including vaccines.

AstraZeneca had started an investigation to check bioreactors in Vietnam for Covid-19 vaccine production, but stopped it because the need for the vaccine was urgent around the world as the pandemic raged.

Speaking of infrastructure, Dr Sarah Schiffling, senior lecturer in supply chain management at John Moores University in Liverpool, UK, said Vietnam would need suitable facilities for production at the desired scale, appropriate technology and sufficient workers with the necessary knowledge to produce vaccines.

The supply chain is probably the most neglected part of vaccine production, she said. This requires many different things, from the ingredients of the vaccine to things like the filters used in the production process and the vials the vaccines are filled into.

In times of extremely high demand, it could be difficult to have sufficient capacity at all stages of the supply chain, from raw materials to finished vaccines, she said.

“With such a sensitive product, it is essential that excellent quality can be guaranteed throughout the production process.”

She acknowledged that Vietnam has a fairly developed pharmaceutical industry, but said specific companies would need to be identified to manufacture Covid vaccines.

But it must take into account the larger environment, including the storage, transport and distribution of vaccines, she said.

Tinglong Dai, professor of operations management and business analysis at Johns Hopkins University Carey Business School in the United States, said vaccine manufacturing based on mRNA is niche technology, and therefore training could take years, and the country should instead recruit experts from companies like Pfizer, BioNTech and Moderna.

Vietnam would need to acquire the technical know-how to make things work and ensure the quality of vaccines, and that is why it needs technology transfer, he said.

Optimistic about Vietnam’s ability

Dai said it was “absolutely technically possible” for Vietnam to produce Covid-19 vaccines because it has a formidable workforce with many educated workers.

The United States has expressed interest in expanding production of Covid vaccines in Asia, he said.

Vietnam “does not need to produce everything” but could instead collaborate with partners, for example South Korea, to produce vaccines, he said.

Moderna and Novavax have signed an agreement with the South Korean government to manufacture their Covid-19 vaccines.

Dai stressed that a country wishing to produce Covid vaccines must consider both supply and demand, and there are uncertainties about demand in the near future as people might prefer more vaccines. recent.

“Without sufficient demand, I don’t think the proposed manufacturing center will be feasible.”

But if the government shows strong political will and commitment, companies could be confident enough to develop and produce vaccines.

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