MFDS Begins Preliminary Review of Novavax and Sputnik V Vaccines

Novavax's COVID-19 vaccine and syringe, company logo
[Image source=Yonhap News]

[Asia Economy Reporter Kim Heung-soon] The Ministry of Food and Drug Safety announced on the 29th that it has begun a preliminary review before the approval application for the Novavax and Russian Sputnik V COVID-19 vaccines.

SK Bioscience, responsible for the production and approval of Novavax in Korea, submitted non-clinical test data on toxicity and efficacy, as well as clinical phase 1 and 2 trial data.

This vaccine is a recombinant protein vaccine created using genetic recombination technology. It is undergoing preliminary reviews by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), among others.

The preliminary review for the Sputnik V vaccine was requested by Huons, which formed a consortium for domestic contract manufacturing of this vaccine. The government has not announced any plans to introduce this vaccine.

The Ministry of Food and Drug Safety plans to review the safety and efficacy of the vaccine based on the non-clinical data submitted by Huons. The Sputnik V vaccine is a viral vector vaccine similar to AstraZeneca and Janssen. It has been approved in 61 countries including Russia, but has not yet been authorized in the United States and Europe.

Preliminary reviews are underway at the EMA, and the vaccine is undergoing evaluation for inclusion in the World Health Organization (WHO) Emergency Use Listing (EUL).

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