Seoul authorities begin review of Korea’s first Covid-19 vaccine candidate of SK

2022.04.18 13:50:56 | 2022.04.18 13:51:23

[Source: SK bioscience]이미지 확대

[Source: SK bioscience]

Korean health authorities have kicked off a review process of SK bioscience’s investigational Covid-19 vaccine (GBP510) to examine its validity as the country’s first homegrown jab against the coronavirus.

The review process started with the application for preliminary review of vaccine quality data from SK bioscience, the Ministry of Food and Drug Safety announced last Friday.

GBP510 is a recombinant vaccine made of coronavirus surface antigens and it is under Phase 3 clinical trials designed to evaluate immunogenicity in six countries, including South Korea. SK bioscience submitted data on the manufacturing and quality of vaccine substances and a finished product.

GBP510 is the first Korean-made Covid-19 vaccine candidate that has entered a Phase 3 trial, which began in August last year.

The company recently announced that global Phase 3 clinical trials and a domestic clinical trial of the vaccine as a booster shot are being conducted at the same time, and it plans to go to market through authorization in Korea and World Health Organization (WHO) pre-qualification (PQ) certification in the first half of this year. The Korean government already signed a purchase contract for 10 million doses of this vaccine pending marketing approval.

Shares of SK bioscience were trading 1 percent higher at 135,500 won Monday.

By Chung Seul-gi and Minu Kim

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