MFDS Begins Preliminary Review of COVID-19 Vaccine Developed by SK Bioscience

[Asia Economy Reporter Gong Byung-sun] The Ministry of Food and Drug Safety (MFDS) announced on the 15th that it has begun the preliminary review of the quality data for the COVID-19 vaccine 'GBP510' developed by SK Bioscience.

SK Bioscience's GBP510 is a recombinant vaccine undergoing immunogenicity comparison Phase 3 clinical trials in six countries, including South Korea. If successfully developed, it is highly likely to become the first COVID-19 vaccine developed in South Korea. This is the first time the MFDS has initiated a preliminary review of a domestically developed COVID-19 vaccine.

GBP510 entered the final development stage, Phase 3 clinical trials, in August last year, becoming the first domestically produced vaccine to do so. SK Bioscience has completed administration to Phase 3 trial participants and is compiling the results, which are expected to be disclosed as early as this month.

SK Bioscience has submitted manufacturing and quality data for both the active pharmaceutical ingredient and the finished product to the MFDS. The company plans to obtain vaccine product approval within the first half of this year. Previously, the government signed a contract to pre-purchase 10 million doses of GBP510.

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