SK Bioscience has completed recruiting subjects for the phase 3 clinical trial of the COVID-19 vaccine candidate ‘GBP510’.
The government announced on the 18th that it held the 26th meeting of the pan-government COVID-19 vaccine and treatment clinical trial support task force (TF) and discussed the progress of domestically produced COVID-19 vaccine development.
In Korea, eight companies are currently conducting clinical trials for COVID-19 vaccines: SK Bioscience, Ubiologics, Geneone Life Science, Genexine, Curatis, HK InnoN, Cellid, and Igene. SK Bioscience’s ‘GBP510’ entered phase 3 clinical trials in August last year and is showing the fastest development speed.
The GBP510 phase 3 clinical trial began administering the first subjects on August 30 last year, targeting a total of 3,990 people. Afterwards, about 4,000 clinical participants were recruited in five months in Korea and five overseas countries: Thailand, the Philippines, Vietnam, Ukraine, and New Zealand.
In the future, SK Bioscience announced that it plans to complete vaccine development within the first half of this year through rapid sample analysis and data acquisition for the vaccine under development.
When development of GBP510 is completed with support from the Coalition for Epidemic Response Innovations (CEPI), it will be supplied to countries around the world through the COVAX Facility.
The government is also proceeding with the pre-purchase process for 10 million doses of the domestically produced vaccine being developed by SK Bioscience.
So far, the government has supported the recruitment of clinical participants and supported rapid clinical progress, including clinical approval, through embassies stationed in countries where clinical trials are being conducted.
Government-led sample analysis to analyze vaccine efficacy is also being supported through the National Institute of Health and the International Vaccine Institute. In order for a company to apply for expedited approval from the Ministry of Food and Drug Safety, it requires analysis of approximately 4,400 samples. As of the 17th, a total of 2,163 samples were received, and analysis of 1,764 samples was completed.
In addition, a cross-over/additional vaccination clinical trial sponsored by the Korea Disease Control and Prevention Agency is also in progress for actual vaccination after the development of a domestically produced vaccine. The clinical trial was approved by the Ministry of Food and Drug Safety on December 23 last year and is currently being conducted by approximately 550 researchers at 10 institutions, including Korea University Guro Hospital.
Second Vice Minister Ryu said, “Even in situations where it was difficult to recruit clinical participants due to COVID-19 vaccination, we were able to successfully complete the recruitment of clinical trial participants for the development of a domestic vaccine thanks to the public’s high interest and active cooperation.”
He added, “We will focus on government-wide support so that sample analysis, approval, review, and commercialization can proceed quickly,” adding, “We will provide support until the end so that various domestic vaccines and treatments, including SK Bioscience, can be developed.”
Source: Pangyo Techno Valley Official Newsroom
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