MFDS Begins Approval Review for Novavax Vaccine Produced by SK Bioscience

Vaccine and syringe placed in front of the Novavax logo (Photo by Jenny Chah, Reuters)

[Asia Economy Reporter Kim Heung-soon] The Ministry of Food and Drug Safety (MFDS) has begun the approval review for the U.S. Novavax COVID-19 vaccine produced by SK Bioscience.

The MFDS announced that SK Bioscience submitted an application for the manufacturing and sales approval of the Novavax COVID-19 vaccine on this day. The Novavax vaccine is one of the five vaccines the government plans to introduce and was developed for a two-dose regimen (28 days apart). Currently, the other four vaccines?AstraZeneca, Pfizer, Janssen, and Moderna?have already been approved domestically.

This vaccine is a 'recombinant protein vaccine' created using genetic recombination technology, developed by injecting the COVID-19 virus antigen protein into the body to generate antibodies. This method is also used in existing vaccines such as the hepatitis B vaccine and the cervical cancer vaccine.

The MFDS stated, "We will thoroughly review the submitted quality, non-clinical, clinical, and GMP (Good Manufacturing Practice) data, and after triple consultations with the COVID-19 vaccine safety and efficacy verification advisory group, the Central Pharmaceutical Affairs Deliberation Committee, and the final inspection committee, we will confirm the product's safety and efficacy before deciding on approval."

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