Korea on right track, but long way to go to becoming vaccine hub

Bold investment needed to develop vaccine sovereignty

By Baek Byung-yeul

Samsung Biologics, SK Bioscience and other biotech companies here are expanding their vaccine development and manufacturing capabilities, as the COVID-19 pandemic has highlighted the importance of having vaccine sovereignty, according to company officials Tuesday.

Korea had a hard time securing COVID-19 vaccines when they were first available because the nation was at the mercy of imports from multinational pharmaceutical companies, which were experiencing supply shortages and shipment delays amid soaring global demand.

With the aim of protecting public health through vaccine sovereignty ― the ability of a country to develop its own vaccines ― and making related businesses become new economic growth engines, Korea is pushing for a plan to become a global vaccine hub.

Under the vision, the country aims to commercialize its first domestically developed COVID-19 vaccine within the first half of 2022 and to invest 2.2 trillion won ($1.79 billion) in the sector to become the world's fifth-largest vaccine-producing nation by 2025.

Officials in the local bioindustry said Monday that the government has shown its willingness to grow the vaccine industry by offering various incentives, such as supporting budgets needed for clinical trials and speeding up the approval period for vaccine development.

They also urged the government to provide policy support from a long-term perspective because developing new drugs and vaccines is a time- and money-consuming task with a low success rate.

"Like the development of new drugs, developing new vaccines could take nearly 10 years from clinical trials to approval. This is one of the areas in desperate need of the government's support," an official from a local biotech company said on the condition of anonymity.

"With the pandemic serving as an opportunity, the country's bioindustry, which had not been attracting much attention, is drawing keen attention. We hope the government will strengthen its efforts further to develop Korea's vaccine industry. The higher the attention to the industry, the more the related industries can grow," the official said.

Among the prominent bioindustry companies here, SK Bioscience is playing an important role in Korea's journey to becoming a global vaccine hub. The company, which has both vaccine development and manufacturing capabilities, is currently conducting global Phase 3 clinical trials of its own COVID-19 vaccine candidate GBP510.

"We are conducting Phase 3 clinical trials of our COVID-19 vaccine candidate with an aim to release it within the first half of this year," an SK spokesman said. "This vaccine will be the first homegrown COVID-19 vaccine. We will do our best to fight COVID-19 by releasing it as planned."

SK Bioscience also seeks commercialization through the World Health Organization's (WHO) global vaccine COVAX Facility project, a worldwide initiative aimed at supporting equitable access to COVID-19 vaccines.

In addition to the development of the GBP510 vaccine, the company is producing U.S. biotech firm Novavax's synthetic antigen-based COVID-19 vaccine, Nuvaxovid. In February, SK Bioscience rolled out the first batch of the vaccines, which will be supplied to Korea, Thailand and Vietnam.

Samsung Biologics has also been emerging as a center for the government's plan to make it a vaccine hub, as the world's largest contract-based drug manufacturer has been producing U.S. biotech company Moderna's COVID-19 vaccine since the third quarter of 2021.

Samsung has been in charge of filling and packaging in the production process of Moderna vaccine vials. The company said it is on course to operate the entire vaccine production process, ranging from drug substances for mRNA-based COVID-19 vaccines to filling and packaging.

"As we announced before, we signed a contract with U.S. drug maker GreenLight Biosciences to produce drug substances. We expect to begin the production of drug substances within the first half of this year," a Samsung spokesman said.

"We were in charge of the filling and packing process for mRNA vaccines, but if raw materials are produced in our facility, our vaccine business capabilities can be expected to improve significantly. Our customers will relieve their concerns about efficient mass production by entrusting us with vaccine production," the official added.

Relatively small companies are focusing their efforts on vaccine research and development as well. They are not only considering completing the clinical phases of vaccine candidates, but also pushing for a business model that transfers their technologies to global pharmaceutical companies before completing the clinical phase, which requires a lot of cost and time.

CHA Vaccine Institute, a subsidiary of CHA Biotech, is currently conducting Phase 2 clinical trials for candidate substances for chronic hepatitis B and Phase 1 trials for herpes zoster.

"The company has the technology that can strengthen our immune systems. We expect that our HBV therapeutic vaccine will not only increase chronic hepatitis B patients' immunity, but also treat their disease, if the efficacy of the vaccine is confirmed through clinical trials," a company spokesman said.

On a related note, Korea achieved a significant milestone in its goal of becoming a global vaccine hub on Feb. 23 when the WHO designated the country a global biomanufacturing training hub. With the designation, Korea will educate 370 trainees from low- and middle-income countries about manufacturing health products such as vaccines and treatments starting this July.

For the training hub plan, the government will cooperate with local bioindustry firms, including Samsung Biologics and SK Bioscience, universities and the International Vaccine Institute, as well as the WHO.

"By sharing these lessons we've learnt from our own experience in the past, we will strive to support low- and middle-income countries in strengthening their biomanufacturing capabilities so that we can pave the way together towards a safer world during the next pandemic," Health Minister Kwon Deok-cheol said in response to the U.N.'s designation of Korea as a global training hub.

The local bio-healthcare industry also welcomed Korea's designation as a vaccine training hub. "The designation does not have an imminent effect on the Korean bioindustry," an industry official working for a local biotech company said on condition of anonymity. "However, the designation proves that Korea's bioindustry has reached the level of transferring related technologies to developing countries."

More support needed

With the government and domestic firms trying to foster vaccine capability, Chae Su-chan, a former professor and director of the Korea Advanced Institute of Science and Technology's (KAIST) Center for Bio-Healthcare Innovation and Policy, assessed that there is still a long way to go for Korea to become a global vaccine hub.

"It is true that Korea manufactures vaccines well. From biosimilar products to vaccine production, the country has as much production capacity as any other country. In particular, Samsung Biologics has fostered its vaccine production capability. The DNA, which Samsung Group has shown excellence in chip production that requires sophistication and mass production capability, seems to be showing the same performance at its bio unit," the ex-director, who now leads Jeonju City's bio-healthcare innovation project, said.

"However, when it comes to developing vaccines, the country still lags behind advanced countries that have prominent biopharmaceutical companies such as Pfizer and GSK. The reason is very simple. This is because the government and private companies cannot afford to invest the funds and time needed to develop vaccines or new drugs," he said.

"The country's R&D expenditures in the bioindustry, combining government support with private investment, are about one-tenth of the amount invested by one of the global biopharmaceutical companies. Those big companies spend astronomical amounts a year. It doesn't make sense to exclaim that the Korean government aims to become a vaccine powerhouse while investing so little."

As Chae mentioned, Korea's R&D spending in the bioindustry is very low. In its financial disclosure, Pfizer said its R&D spending for 2021 was at $13.829 billion, while Korean bioindustry companies' total biopharmaceutical R&D spending in 2020 was 1.4771 trillion won ($1.22 billion), according to the Ministry of Trade, Industry and Energy's December 2021 data.