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Conditions for vaccine technology transfer

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Vaccine production is every government’s top priority to ensure its people’s long-term well-being, during and after the pandemic. However, what is a realistic assessment of Vietnam’s vaccine production capacity? What are the necessary and sufficient conditions for Covid-19 vaccine technology transfer in Vietnam?

This article focuses on the necessary and sufficient conditions for Covid-19 vaccine technology transfer in Vietnam.

Five questions warrant consideration and clarification. The first issue pertains to the efficacy of vaccines in view of increasingly dangerous and virulent strains, which may give rise to asymptomatic cases. Second, who can and want to transfer vaccine technology to Vietnam? Third, what are the conditions in terms of the legal framework? The last two issues relate to the necessary and sufficient conditions for successful technology transfer.

Regarding the first issue, local efforts to develop vaccines—Nanogen, Polyvac Vabiovac and IVAC—are admirable. A challenge facing vaccine developers is how to deal with variants.

Of paramount importance is the efficacy of vaccines. Assessments by the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer important insights on this matter. It will be disastrous to pour money into substandard food and medicine, which the human body will consume. Research capabilities should be evaluated, so that Vietnam can become increasingly proactive. Money alone may not be sufficient to meet this challenge.

What vaccines can Vietnam produce and which technology should it adopt? It takes more than money to access complex vaccine production technology. Once production starts, at least 60 tests are required, equipment must be sanitized twice at a temperature of 300oC and packaging must take place in an aseptic environment, free from fine dust. Negative temperatures are needed for storage while mRNA technology requires a stable supply of electricity under all circumstances. Which technology should then be chosen among (1) attenuated virus vaccines, (2) inactivated virus vaccines, (3) protein subunit vaccines, (4) viral vector vaccines and (5) mRNA, RNA or recombinant DNA vaccines (which relies on nucleic acid processing to enhance immunity)?

Equipment and production chains rely strictly on the technology in use.

Consider, for example, mRNA technology, which has received much attention but has not been implemented in Vietnam as four foundation technologies are required—computational biology technology to handle the genetic sequencing and/or mRNA antigens for the virus and its variants; DNA recombination to form vectors (molecular machines); nucleic acid synthesis; as well as nucleic acid purification and packaging.

Regarding the second issue, Pfizer+BioNTech has chosen Singapore to expand its production and so has Sanofi+GS. AstraZeneca has picked India’s Serum Institute, Korea’s SB-Bioscience and Thailand’s Siam Bioscience. Moderna opts for Korea’s  Samsung Biologics. Over two hundred other production facilities in the world have limited capacity and may not even meet domestic demand, so they are unlikely to aim for overseas markets. Merck, a vaccine powerhouse in the United States seems rather secretive. Sputnik V, Sputnik Light, Sinopharm, Sinovac, Johnson & Johnson, Novavax and Euroimmun are some emerging manufacturers who enjoy second-mover’s advantages (such as ease of storage, resistance to new variants, better access to inputs and markets, lower prices and so on), so they will be potential partners for manufacturing (phase 1) and technology transfer (phase 2).

However, the market of vaccines is that of sellers, not buyers. India and Korea are the two biggest vaccine producers. East Asian countries have tried their best to find partners for technology transfer and are willing to manufacture vaccines as the first phase. Suppliers have many choices, including India, China, Indonesia, Japan and the Philippines, so it will be challenging to be picked by renowned firms.

Vietnam has 227 pharmaceutical plants but only 17 can manufacture injections, similar to vaccines, on a small scale. It takes from two to three years to build a new plant but uncertainty pervades the situation then, especially if the researchers only have PhDs but are not famous scientists. Suppliers tend to say diplomatically that they will study the possibility of technology transfer but it is too early to assume this will materialize and boast about it in the media. This is disastrous, especially as the Prime Minister has highlighted the need to guard against hasty assertions that fail to come true.

Many pharmaceutical powerhouses eye Japan, with at least four companies with outstanding infrastructure, including Daiichi Sankyo, Shionogi Pharmaceutical and an international vaccine development center. It is also worth mentioning Korea’s Genexine; Taiwan’s Adimmune, Vaccin Biologics and United Biomedical; India’s Bharat Biotech and Biological-E; Thailand’s Chulalongkorn University and Mahidol University; and Indonesia’s Merah Putih, a collaborative effort between Indonesia University and its Academy of Sciences. Vietnam is just one option even if it meets all conditions.

The third issue pertains to the legal framework. Compatibility with international laws and the laws of related countries, including those on pharmaceutical products, licenses and patents.

Accessing technology entails more than just intellectual property rights. For example, since October 2020, Moderna has announced that it allows mRNA technology to be adopted, but Sai Trasd, CEO of Bharat Biotech, says that a vaccine may require hundreds of rare ingredients or even single-use plastic. The lipid shell for nucleic acid is produced predominantly by Evonik Industries in Hanau (Germany); it has been under BioNTech for a long time.

Stéphane Bancel, CEO of Moderna, says that mRNA technology is hard to transfer, not to mention the fact that no suppliers completely give up intellectual property rights pertaining to Covid-19 vaccines. The recipients of the technology must have not just intellectual property rights, but also collaborative and licensing agreements with patent owners. Ms. Karikó’s research paves the way for the vaccine but the patent is owned by University of Pennsylvania. A comprehensive solution that offers all the key conditions is essential for success, and legal issues are just one of the challenges to tackle.

As for necessary conditions, the short answer is that Vietnam needs to be accepted as a strategic partner in technology transfer. It must work closely with the original suppliers to flesh out plans for licensing, material supply, storage and quality control while putting in place the necessary equipment, lab facilities, skilled human resources, software systems, Artificial Intelligence and automation technology. Plans for manufacturing, quality control during and after production, maintenance and distribution must be developed, too.

Finally, the sufficient conditions are business strategies, research and development infrastructure, human resources capable of developing future products and financial capabilities.

In short, as the British Medical Journal 5-2021 puts it, vaccine production requires inputs, infrastructure, equipment, quality control and skilled human resources. Senior specialists well-versed in vaccine technology, as well as visionary leaders, will play a vital role.

By Nguyen Thanh Lam (*)

(*)Head of the project “Strategic collaboration in biomedical technology, science and vaccines,” TP Pharma Group

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