SK Bioscience Files for Approval of Novavax’s COVID-19 Vaccine

SK Bioscience has submitted a Biologics License Application (BLA) for Novavax’s COVID-19 vaccine to Korea’s Ministry of Food and Drug Safety (KMFDS).

SK Bioscience had previously procured the license to manufacture and sell Novavax’s shot, also known as NVX-CoV2373, this February. The company has since completed the transfer of Novavax’s protein-based recombinant nanoparticle technology to its production plants. SK Bioscience expects to supply up to 40 million doses in the country alone.

NVX-CoV2373

If approved, the shot will be the first protein-based COVID-19 vaccine to be distributed in South Korea. The vaccine includes saponin-based Matrix M adjuvant, which boosts immune response and induces a high level of neutralizing antibodies. An added benefit is that the shot can be stored at 2 to 8 degrees Celsius, allowing it to be distributed without thawing at the inoculation stage.

Novavax’s vaccine has demonstrated efficacy and safety in a pivotal Phase 3 PREVENT-19 trial. The shot was found to prevent infection 90.4% of the time, with a 100% protection against moderate to severe disease. The study enrolled nearly 30,000 adult participants from the US and Mexico.

Another study that recruited over 15,000 participants in the UK showed that the shot had an efficacy of 89.7% overall and 96.4% efficacy against the original virus strain. 

On the safety front, most of the side effects occurring after injection were mild or moderate.

Emergency Use in Other Countries

The results were enough to convince Indonesia to approve the shot for emergency use. Novavax has also filed for emergency use listing (EUL) of the shot to the WHO. Similar filings have been made in the UK, Australia, New Zealand, Canada, and the EU.

Everything said the shot is expected to get speedy approval from the South Korean government.

“Novavax’s protein-based vaccine, which has proven its effectiveness, safety, and even distribution convenience, will be a new cornerstone in overcoming the global COVID-19 pandemic situation,” said Jae-Yong Ahn, CEO of SK Bioscience. “We will cooperate closely with the Korean government to supply sufficient quantities of Novavax’s vaccine in Korea since we were able to establish an independent production plan based on our technology transfer agreement with Novavax.”

Author

Joy Lin

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