On Monday, Korea initiated the administration of Novavax's updated Covid-19 vaccine to prevent infection from the XBB.1.5 subvariant, marking the first instance of its use in Asia.

Novavax’s updated Covid-19 vaccine (NVX-CoV2601), the only non-messenger RNA formulation to target the XBB.1.5 subvariant in the world, is widely available for individuals aged 12 and older for free at designated hospitals and health centers in Korea.

SK bioscience, which exclusively distributes Novavax’s updated Covid-19 vaccine in Korea, said CEO Ahn Jae-yong encouraged vaccinations by receiving the shot at a clinic near its headquarters in Seongnam, Gyeonggi Province, on Monday.

“As we head into the holiday season in winter, Novavax’s updated Covid-19 vaccine emerges as a new option for national immunization. Vaccination is the easiest way to protect us and our loved ones,” Ahn said.

SK bioscience explained that the Novavax vaccine is a synthetic antigen vaccine produced by the same gene recombination technology, which is also used to produce hepatitis B and influenza vaccines.

“There are no safety concerns with the Novavax vaccine because it is based on a genetic recombination platform that has been used for many years,” said Jung Jae-hun, professor of preventive medicine at Gachon University College of Medicine. “The relatively low cumulative dose compared to Pfizer and Moderna’s vaccine may lack sufficient data to assess side effects, but no serious adverse events have been reported so far.”

The Ministry of Food and Drug Safety (MFDS) granted an emergency use authorization (EUA) for Novavax’s updated vaccine on Nov. 29. It was the first approval in Asia, and the third approval globally followed by the U.S. and the EU.

Novavax’s updated vaccine also has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent Covid-19 in individuals aged 12 and older on Nov. 28.

The EUL assists WHO's 194 member states in assessing vaccines to expedite regulatory approvals to import and administer the vaccine.

In non-clinical trials, Novavax's updated Covid-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16, and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induces neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

In August 2023, SK bioscience made a strategic equity investment in Novavax, transforming a pandemic-era CMO/CDMO partnership into a long-term synergistic relationship, acquiring 6.5 million shares of common stock in a private placement.

Concurrent with the equity investment announcement, SK bioscience and Novavax have extended their current license agreement, adding Novavax’s updated Covid-19 vaccine.

The agreement serves as a strategic shift of partnership from the pandemic period to the endemic phase, in which SK bioscience will obtain exclusive rights to Novavax’s updated vaccine in Korea and non-exclusive rights in Thailand and Vietnam to supply and commercialize the vaccine.

Through the extended license agreement, SK bioscience will establish a preemptive response system in Korea’s immunization environment for the endemic era and enhance its global competitiveness as Covid-19 shifts to an annual vaccination market.

In particular, SK bioscience’s two-track strategy, which consists of the development of its vaccines as well as a fast supply of vaccines developed by global pharmaceutical companies, is expected to set the foundation for SK bioscience to systematically respond to the rapidly changing vaccine demands.

On Thursday, SK bioscience held a covid-19 vaccination encouragement campaign in Seoul. At the event, models of a child, a mother, and a grandfather performed with large vaccine syringes and shields to defeat the Covid-19 virus.

SK bioscience is the only biopharmaceutical company which has developed Korea’s first homegrown original Covid-19 vaccine, SKYCovione, in June 2022.

SKYCovione is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with a combination of GSK’s pandemic adjuvant.

The development of SKYCovione has been supported by funding from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the EU's Horizon 2020 program.