SK Bioscience said it has submitted a product approval application to the Ministry of Food and Drug Safety for NVX-CoV2373, a Covid-19 vaccine developed by Novavax.
The approval of NVX-CoV2373, administered in 0.5-ml dose to the muscle twice at 21-day intervals, will undergo a review by an expert advisory meeting within the Ministry of Food and Drug Safety and a final inspection committee on the vaccine's efficacy and safety.
Novavax had confirmed the excellent preventive effect of NVX-CoV2373 through clinical trials.
Novavax demonstrated a total prevention rate of 90.4 and 100 percent prevention of moderate and severe infections in phase 3 clinical trial of NVX-CoV2373 conducted in the U.S. and Mexico in June with 30,000 adults over 18.
Also, in the results of the phase 3 clinical trial of NVX-CoV2373 targeting 15,000 adults aged 18 to 84 in the U.K., the company confirmed an overall prevention rate of 89.7 percent, while the preventive effect for the original Covid-19 virus was 96.4 percent.
In terms of safety, most of the adverse reactions that occurred after vaccination were mild or moderate.
SK Bioscience holds the right to manufacture and commercialize NVX-CoV2373 in Korea.
Following the contract development and manufacturing organization (CDMO) service contract with Novavax in August last year, SK Bioscience signed a technology transfer contract, including undiluted solution and finished product in February.
As the company has recently received the protein-based nanoparticle recombination and production process technology, SK Bioscience expects to start the supply of NVX-CoV2373 as soon as they obtain product approval. In addition, the company signed a supply contract with the Korea Disease Control and Prevention Agency for 40 million doses of NVX-CoV2373.
"I am grateful to SK Bioscience, which has cooperated to ensure that the whole world, including Korea, can receive our vaccines fairly," Novavax CEO Stanley Erck said. "This application for approval will be another important milestone in Novavax's growth as a global vaccine company and an opportunity to present a variety of approaches to international cooperation to control the pandemic."
SK Bioscience CEO Ahn Jae-yong also said, "Novavax's synthetic antigen vaccine, which has proven effectiveness, safety, and ease of distribution, will be a new turning point in controlling the spread of Covid-19 infection."
As it is possible to establish an independent production plan through a technology transfer contract, the company will work closely with the government to supply sufficient quantities to Korea, Ahn added.