SK Bioscience Expands CMO Contract for Novavax Vaccine

Novavax COVID-19 vaccine contract manufactured (CMO) by SK Bioscience. / Photo by Lee Chun-hee.

[Asia Economy Reporter Lee Chun-hee] SK Bioscience is expanding its contract manufacturing organization (CMO) agreement for the Novavax COVID-19 vaccine.

On the 24th, SK Bioscience announced that it has signed a CMO and license agreement for the production of the active pharmaceutical ingredient (API) of Novavax's COVID-19 vaccine ‘NVX-CoV2373’ and its global supply. The contract period extends until December next year. SK Bioscience plans to utilize three of the nine API production facilities at its Andong L-House vaccine plant for the production of the Novavax vaccine.

The contract stipulates that SK Bioscience will receive a contract manufacturing fee from Novavax for API (DS) production and a sales commission based on Novavax's finished product (DP) sales. In South Korea, Thailand, and Vietnam, SK Bioscience secures the rights to supply and commercialize the vaccine upon requests from each country's government, thereby generating additional sales through vaccine supply.

The API contract is structured so that SK Bioscience receives contract manufacturing fees based on the production volume supplied to Novavax. The finished product contract allows Novavax to manufacture and sell finished products from the volume produced at one of the API production facilities in Andong, with SK Bioscience receiving a commission based on sales.

The total contract value based on Novavax's minimum guaranteed purchase quantity amounts to $171.7 million (approximately KRW 203.8 billion). This amount may increase depending on actual purchase volumes.

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

Following the CMO contract signed with Novavax in August last year, SK Bioscience entered into a license agreement including both API and finished products in February and has been producing the Novavax vaccine since then. The company has completed the transfer of protein-based nanoparticle recombinant and production process technologies necessary for vaccine manufacturing, finalizing all preparations for commercial production.

The Novavax vaccine is distinguished by its development on a synthetic antigen platform that has been used for a long time in existing vaccines such as influenza, hepatitis B, and cervical cancer vaccines, demonstrating proven safety and efficacy. It can be stored under refrigerated conditions at 2?8 degrees Celsius, allowing distribution through existing vaccine logistics networks without the need for thawing during administration.

Novavax reported that clinical trials involving over 30,000 adults aged 18 and older in the United States and Mexico showed a 90% efficacy rate in preventing COVID-19 infection. Regarding safety, most adverse reactions following vaccination were mild or moderate. Furthermore, for the recently spreading Omicron variant, a third dose of the Novavax vaccine resulted in antibody levels that were 9.3 times higher compared to the second dose for Omicron and 11.1 times higher for the Delta variant.

Stanley Erck, CEO of Novavax, stated, “SK Bioscience and South Korea are very important partners for us in supplying COVID-19 vaccines worldwide. This collaboration will expand our global network for commercializing high-quality products and contribute to our goal of producing 2 billion vaccine doses next year with our partners.”

SK Bioscience President Ahn Jae-yong said, “This is another meaningful achievement for SK Bioscience as a vaccine CMO company and a demonstration of our global-level vaccine production capabilities. We will strive to establish ourselves as a true global vaccine supply hub and achieve the shared goal of protecting vulnerable populations through equitable vaccine distribution.”

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