Wary of Covid-19 vaccine shortages, several Asian governments are determined to develop home-grown shots

Japan, South Korea, India, Taiwan, Thailand, Indonesia and Vietnam are all betting on multiple locally developed vaccine candidates after struggling to secure adequate supplies of shots from overseas. Although locally developed vaccines are unlikely to arrive in time to save sluggish vaccine roll-outs, authorities and scientific experts regard the approach as a longer-term investment.

Many experts expect Covid-19 to circulate indefinitely. It means the emergence of variants resistant to existing vaccines and the potential need for booster shots to maintain immunity could fuel vaccine demand for years to come. Where supply exceeds domestic demand, countries that have developed their own vaccines may be able to capitalise on demand in poorer countries, creating openings for vaccine diplomacy.

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"If you make the assumption that Covid-19 will be around beyond 2022, there could be a strong economic justification for these latecomers," said Jerome Kim, director general of the International Vaccine Institute (IVI) in Seoul.

Kim said the first wave of vaccines could become "less useful" due to complications such as virus mutations, safety concerns, cost and logistical challenges.

"For instance, do side effects get more severe or immune/protective responses less robust after the third dose of the Johnson & Johnson vaccine or the Moderna mRNA vaccine?" Kim said. "Will the very rare instances of blood clots cause decreased use of adenovirus-based vaccines as newer protein vaccines become available?"

Ken Ishii, director of the International Vaccine Design Center in Tokyo, predicted one or two home-grown vaccines would be available in Japan by the second half of 2022.

Although a home-grown vaccine would not help Japan reach herd immunity this year, Ishii said countries should develop their own vaccines to safeguard their health systems and economies, and expand their diplomatic and soft power arsenals.

"It will make a difference if the Covid-19 vaccine becomes a 'seasonal' vaccine like [that for] flu," he said.

Ishii said countries such as Japan, South Korea and Thailand will be able to develop their own vaccines provided they properly conduct final-stage phase 3 clinical trials, which observe large numbers of participants for side effects and treatment efficacy.

Kentaro Iwata, an infectious disease expert at Kobe University, said development could be a challenge in Japan due to the country's historic lack of capacity to carry out clinical trials.

"Japan did not put importance on clinical studies," Iwata said. "Now they are trying to catch up."

In April, Health Minister Kwon Deok-cheol said one or two vaccines should be approved for use by the end of 2021 or early 2022. The same month, Minister of Science Choi Ki-young told a parliamentary session he was confident a home-grown vaccine would be available before the end of 2021. Officials in Seoul hope to achieve herd immunity among the city's population by November.

"Several Korean biologics manufacturers have FDA and European Medicines Agency-approved products, so they understand the requirements of stringent regulatory authorities," Kim said about the IVI. "The Korean government has targeted vaccine self-sufficiency by 2025 and made infrastructure, R&D and capacity investments for the past several years."

In Taipei, more than 7,000 cases have been reported in the past month after the city remained largely Covid-free during the height of the pandemic. Officials last week announced deals to buy 20 million doses of the Vaccine Biologics and United Biomedical candidates, both of which are subject to phase 2 trials.

The decision stirred controversy on the self-ruled island, where fewer than 2 per cent of the population have received a shot, and some commentators have questioned the wisdom of purchasing vaccines not yet proven safe and effective.

Health Minister Chen Shih-chung last week announced the government would ease regulations to allow local authorities and businesses to import vaccines, after Foxconn billionaire Terry Gou was blocked from buying 10 million doses of the Pfizer-BioNTech vaccine through mainland Chinese firm Fosun.

Taiwanese President Tsai Ing-wen has accused Beijing of blocking a deal to import vaccines directly from German firm BioNTech, after Taipei rejected offers of vaccines from Shanghai-based Fosun, which has been contracted to supply the Pfizer-BioNTech jab in mainland China, Hong Kong, Macau and Taiwan. Beijing, which considers Taiwan a breakaway province with no right to international relations, has accused Taipei of playing politics by shunning its offers of assistance to acquire vaccines.

Shih-Jen Liu, an investigator at the National Institute of Infectious Diseases and Vaccinology in Taipei, said it will be difficult to complete phase 3 trials this year, making the government's July target for delivering local vaccines unrealistic.

"The difficulties for the vaccine industry in Taiwan are due to the small market size and lack of a complete vaccine industry supply chain," Liu said. "Most of the raw materials for vaccine manufacturing come from abroad. We spent a lot of time waiting for the raw materials to come. However, making our own vaccines is important because purchasing the vaccines is not easy. Taiwan has many political issues it has to face."

Liu said it was vital the government push firms developing vaccines to conduct phase 3 trials as soon as possible.

"Because different variants are identified in different regions, a boosting of the Covid-19 vaccines may be needed," he said. "If this is the case, the investment in phase 3 clinical trials is worth it."

Bharat Biotech, based in Hyderabad, aims to supply 80 million doses of Covaxin, which has yet to receive WHO approval, per month from August. It is also developing a nasal spray vaccine. Supplies are running short after the government opened vaccinations to all adults last month. Some vaccination centres have closed down, prompting criticism from the Supreme Court about a lack of planning.

Biological-E, a Hyderabad-based vaccine and pharmaceutical company, has completed phase 1 and phase 2 trials of a protein-based jab similar to the Novavax vaccine, and last month received government approval to begin phase 3 trials.

The Indian government, which has pledged to vaccinate every Indian by the end of 2021, on Thursday ordered 300 million doses of the jab, which is being developed in cooperation with the Houston, Texas-based Baylor College and expected to arrive between August and December.

"The arrangement with Biological-E is part of the wider endeavour of the government of India to encourage indigenous vaccine manufacturers by providing them support in research and development and also financial support," the health ministry said this week.

Pune-based biotechnology company Gennova Biopharmaceuticals in April began enrolment for phase 1 and phase 2 trials for the country's mRNA-based vaccine, HGCO19.

Thailand, Vietnam and Indonesia are all banking on locally developed vaccines.

Kiat Ruxrungtham, who is leading the development of the Chulalongkorn University vaccine, said it could be ready for mass production by early 2022. He said his team planned for their vaccine to function as a booster for emerging variants after most Thais have been inoculated with the first-generation AstraZeneca and Sinovac jabs.

"It's not going to compete with the first-generation vaccine," Kiat said. "I think for us, it's most important to look at the long-term and sustainability."

Kiat said Thailand could also become an exporter of vaccines to less developed countries in the region, such as Cambodia and Laos.

"I think it's good that each region should have a number of countries that have this capability to make their own vaccine when a pandemic hits," he said. "I think that's very serious. At the same time, this platform will allow us to explore other diseases."

Phase 1 trials for a locally developed inactivated virus vaccine, developed by the state-run Government Pharmaceutical Organization and Mahidol University in partnership with the Programme for Appropriate Technology in Health, a US non-profit group, began in March.

Nanocovax could be delivered as early as September, according to the country's health ministry, while IVAC has indicated Covivac will be available by the first quarter of 2022. Two other vaccines in development by state-owned companies are yet to begin human trials. 

Vietnam, which has endured delays in shipments of AstraZeneca shots supplied by Covax, the global vaccine initiative, has so far inoculated about 1 per cent of its 96 million people.

Thu Anh Nguyen, the country director of the Woolcock Institute of Medical Research in Vietnam, said domestic development was vital.

"The country cannot and does not want to depend on any risks of taking vaccines from other countries as we are seeing the global issue at this moment," Thu said.

In April, the country's food and drugs agency controversially approved private research on a second locally developed jab, Nusantara, to facilitate phase 2 trials, after earlier determining it had failed to meet the criteria to progress beyond the initial stage.

With so many candidates in development, the pandemic has changed the calculation involved in undertaking costly and time-consuming vaccine research.

Kim, the director general of Seoul's IVI, said the pandemic had upended assumptions about economic feasibility and first-mover advantage that discouraged vaccine development in the past.

"Some of the older notions may not apply to Covid-19 vaccines; for example, no one wanted to be the third Indian company and the fifth vaccine manufacturer to have a paediatric rotavirus vaccine," he said. "We are at 10 Covid-19 vaccines and counting.

"Depending on the constraints of global manufacturing capacity, there could still be billions of doses required, and if booster or variant virus vaccines are needed, billions more."

Additional reporting by Sonia Sarkar

This article originally appeared on the South China Morning Post (SCMP).

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