Will It Become the 5th Domestic Vaccine? Announcement on Novavax Vaccine Approval in Korea Tomorrow

The Novavax COVID-19 vaccine, contract developed and manufactured (CDMO) by SK Bioscience, is displayed at the Ministry of Food and Drug Safety. Photo by Lee Chunhee

[Asia Economy Reporter Lee Chun-hee] The domestic approval of the Novavax COVID-19 vaccine is scheduled to be decided and announced on the 12th. If approved, it will become the fifth vaccine used domestically, following AstraZeneca (AZ), Pfizer, Moderna, and Janssen.

The Ministry of Food and Drug Safety (MFDS) announced on the 11th that it will hold a final review committee meeting on the morning of the 12th at the MFDS conference room in Osong, Chungbuk, to decide on the approval of the Novavax COVID-19 vaccine, and will announce the results in the afternoon of the same day.

The MFDS conducts reviews through a triple advisory process involving the COVID-19 vaccine and treatment verification advisory group, the Central Pharmaceutical Affairs Deliberation Committee, and the final review committee. In the review process of other COVID-19 vaccines, results were announced at each stage through briefings, but for the Novavax vaccine, the MFDS decided to announce the final results, including those from the verification advisory group and the Central Pharmaceutical Affairs Deliberation Committee, all at once during the final review committee meeting.

The Novavax COVID-19 vaccine was developed using a synthetic antigen method, unlike the virus vector platform (AstraZeneca, Janssen) or messenger RNA (mRNA, Pfizer, Moderna) platforms used for existing COVID-19 vaccines. Since this method has traditionally been used in various vaccines such as influenza, hepatitis B, and cervical cancer, it is understood that concerns about side effects from vaccination are not high. According to the international academic journal 'Nature,' among the 50 synthetic antigen vaccines currently in clinical trials, none have shown side effects such as myocarditis, pericarditis, or thrombosis, which are representative side effects of existing COVID-19 vaccines. Considering these characteristics, the authorities plan to proceed with vaccinations mainly targeting unvaccinated individuals who have avoided vaccination due to concerns about side effects from existing vaccines.

Our government signed a contract last year to receive 40 million doses of the Novavax COVID-19 vaccine. However, due to delays in approval by the U.S. Food and Drug Administration (FDA) and domestic authorization, all vaccine supplies have been postponed to this year. Currently, SK Bioscience holds all domestic production and commercialization rights for the Novavax vaccine. SK Bioscience signed a contract for contract development and manufacturing organization (CDMO) with Novavax in August 2020, and in February last year, also signed a technology transfer contract to produce both the active pharmaceutical ingredient and finished products.

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