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| Seo Kyung-won, the director general of the National Institute of Food and Drug Safety Evaluation, announces the advisory panel's opinion on SK Bioscience's COVID-19 vaccine at the Ministry of Food and Drug Safety's office in Cheongju, North Chungcheong Province, Monday. Yonhap |
Korea's 1st COVID-19 vaccine likely to be approved in June
By Baek Byung-yeul
SK Bioscience has moved one step closer toward rolling out Korea's first COVID-19 vaccine, as the government advisory panel of pharmaceutical experts determined that a license for the use of the vaccine can be granted, according to the Ministry of Food and Drug Safety (MFDS), Monday.
"The COVID-19 vaccine developed by SK Bioscience is the first COVID-19 vaccine produced in Korea from raw materials to a finished product," Seo Kyung-won, the director general of the National Institute of Food and Drug Safety Evaluation, said during a briefing at the MFDS' headquarters in Cheongju, North Chungcheong Province.
The MFDS said that the advisory panel had analyzed the clinical data of SK Bioscience's COVID-19 vaccine, called SKYCovione, also known as GBP510, on Sunday and evaluated that its effects in preventing the coronavirus are significant and that it has no major safety issues.
"The advisory group advised that the necessity was recognized for the purpose of preventing COVID-19 in Korea, and that the vaccine could be approved when considering the advisory results of the COVID-19 Vaccine Safety and Effectiveness Verification Advisory Group," the MFDS said.
The advisory group also suggested that young adults were more likely to have side effects such as fatigue, muscle pain, headache, chills and fever, compared to elderly recipients after having their first shot compared to with their second shot of the vaccine, adding that guidance on this part is needed when people receive their first vaccinations.
Under the law, newly developed vaccines or treatments for COVID-19 can win approval after passing a three-step consultation process: being evaluated by the COVID-19 Vaccine Safety and Effectiveness Verification Advisory Group first, being evaluated by an advisory group of pharmaceutical experts next and then evaluation by a final inspection committee.
The MFDS said it will hold a final inspection committee evaluation in June to decide whether to grant the vaccine the license after combining data on SKYCovione submitted by SK Bioscience and the evaluations of the other advisory groups.
"The final approval of SKYCovione will be made within this month if possible, including holding the final inspection committee evaluation," Seo said.
SK's vaccine, in which two shots must be given four weeks apart, is jointly developed with the University of Washington's Institute for Protein Design. If the product is approved for use, the company will begin selling the vaccine starting from the second half of this year.
In response to the government's announcement, SK Bioscience showed a cautious stance as the company has one more hurdle to get over before winning the health authority's approval for its vaccine.
"As the final decision of the final inspection committee is still ahead, we are cautious about what was announced today," a company spokesman said.
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