COVID-19 Beyond the Global Peak... Diverging Vaccine Development and Production Strategies

[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] As predictions emerge worldwide that the peak of the COVID-19 spread has passed, companies that had been developing additional COVID-19 vaccines or pursuing contract manufacturing (CMO) are experiencing mixed fortunes. Some companies are halting related projects due to declining business viability and unexpected variables, while others are leveraging additional research and development (R&D) as an opportunity to discover future revenue streams.

According to the industry on the 14th, Genexine decided to halt the Phase 2 and 3 clinical trials of the COVID-19 DNA vaccine 'GX-19N,' which was approved last year in Indonesia. The company explained the reason for stopping the trials by stating, "The vaccine supply situation in Indonesia has improved," and "It is difficult to recruit and manage clinical trial participants, including the placebo group, and ethical issues may arise." Additionally, all plans for booster shot clinical trials were voluntarily withdrawn.

Within the industry, it is viewed that since existing COVID-19 vaccines like Pfizer and Moderna have become mainstream and vaccination rates have significantly increased, especially in developed countries where booster shots are already widely administered, the need for additional vaccine development has substantially decreased. The Novavax vaccine, which was expected to meet unmet demand as a protein subunit vaccine, has not clearly contributed to increasing vaccination rates, leading to predictions that even if it enters the market further, expanding market share will be difficult.

Russian-made COVID-19 vaccine 'Sputnik V' produced at Korea Chorus factory [Image source=Yonhap News]

Adding to this situation, geopolitical factors such as Russia's invasion of Ukraine have also put CMO businesses at risk.

Huons Global, which was pursuing CMO for the Russian vaccine Sputnik V, announced the suspension of the business. Along with its affiliate Humedix and others forming a consortium, they had continued the CMO business, but on the 10th, they stated, "Since the Russian government has included South Korea on the list of unfriendly countries, various sanctions including diplomatic restrictions are expected," and "Considering the unstable international situation, it is judged that maintaining the contract's validity is impossible, leading to the unavoidable decision to suspend the business." The vial line, for which Humedix invested about 10 billion KRW to fill Sputnik V vaccines, will be repurposed for other pharmaceuticals, including vaccines, in the future.

Korea Corus, which leads another domestic Sputnik V CMO consortium, is also in a difficult position. As the international community sanctions Russia and Russia retaliates with counter-sanctions against South Korea, uncertainty is increasing.

SK Bioscience 'L House Vaccine Center' in Andong-si, Gyeongbuk (Photo by SK Bioscience)

Despite these circumstances, some companies continue developing COVID-19 vaccines and pursuing CMO. SK Bioscience is advancing the development of 'GBP510,' expected to be the first domestically developed COVID-19 vaccine in South Korea. They are conducting Phase 3 and booster shot clinical trials, aiming to obtain domestic approval within the first half of this year.

However, the industry is also showing signs of downward adjustment in GBP510's value in response to market changes. Hana Kang, a researcher at eBest Investment & Securities, said last month, "With high COVID-19 vaccination rates and the need for additional heterologous and homologous booster shot trials, the upside is limited," lowering GBP510's market value sharply from 9.78 trillion KRW to 2.93 trillion KRW.

SK Bioscience is not stopping at GBP510 but is expanding it by developing additional vaccines to respond to COVID-19 variants such as Omicron, as well as engaging in mRNA vaccine platform R&D. Notably, they are aiming to enter clinical trials within this year for a 'combo vaccine' that simultaneously prevents COVID-19 and influenza.

Samsung Biologics, responsible for the drug product (DP) manufacturing of Moderna's mRNA vaccine, is accelerating production of drug substance (DS) as well. In November last year, they formed a partnership with GreenLight Biosciences in the U.S. for mRNA vaccine DS contract manufacturing, planning to promote global vaccination starting with low-income countries. They are currently preparing facilities and plan to begin vaccine bulk production within the first half of this year.

This content was produced with the assistance of AI translation services.