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(LEAD) SK Bioscience's COVID-19 vaccine candidate inches closer to launch after experts' approval recommendation

11:25 June 27, 2022

(ATTN: ADDS more info throughout; CORRECTS institute's name in para 4)

SEOUL, June 27 (Yonhap) -- South Korea's first COVID-19 vaccine candidate, developed by SK Bioscience Co., has received an approval recommendation from a government advisory group of pharmaceutical experts, officials said Monday, pushing the vaccine candidate one step closer to commercial launch.

The Ministry of Food and Drug Safety said GBP510, the vaccine candidate developed by SK Bioscience, was recommended during a meeting of the ministry's Central Pharmaceutical Review Committee on Sunday as being ready for "item approval" in terms of its safety and efficacy.

GBP510, also known as SKYCovione, is the country's first homegrown vaccine candidate to have successfully completed all three phases of its clinical trial. SK bioscience conducted a phase-three clinical trial in some 4,000 adults in six countries -- Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.

The vaccine candidate is a recombinant-protein vaccine based on novel two-component nanoparticles that can maximize the immune effect. It was jointly developed with the Institute for Protein Design at the University of Washington.

GBP510 has been designed for recipients to receive two jabs in a span of four weeks.

The government has reached a deal to buy 10 million doses of SK Bioscience's vaccine.

Authorities have tested GBP510 by comparing it with the coronavirus vaccine of AstraZeneca Plc. The committee concluded that the South Korea-developed vaccine demonstrated superiority in terms of immunogenicity.

The committee also concluded the candidate's safety profile was in line with that of AstraZeneca's.

A suspected adverse reaction case involving rapidly progressive glomerulonephritis was reported, but the subject later recovered, according to officials. The committee recommended the government to follow-up on recorded side effects after the product's approval.

Seo Kyung-won, head of the National Institute of Food and Drug Safety Evaluation, said authorities plan to decide whether to approve the vaccine candidate within the week.

Following the experts' recommendation, a SK Bioscience official said the company plans to make further efforts to have the vaccine candidate approved for commercial use by health authorities.

This photo provided by SK Bioscience Co. shows GBP510, South Korea's first COVID-19 vaccine candidate also known as SKYCovione. (PHOTO NOT FOR SALE) (Yonhap)



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