Home World SK vasa clinical trial approved even though ‘10% of Koreans’ were not met… preferential?

SK vasa clinical trial approved even though ‘10% of Koreans’ were not met… preferential?

by news dir
Lee Jong-seong, Representative for People’s Power./News 1 © News1 Reporter Shin Woong-soo

Although SK Bioscience (hereafter referred to as SK Vasa) failed to meet the clinical guidelines that it should recruit 10% of Koreans for the COVID-19 vaccine clinical trial, it was pointed out that the Ministry of Food and Drug Safety had unusually approved the phase 3 clinical trial and gave preference.

According to Lee Jong-seong, a member of the National Assembly’s Health and Welfare Committee, a member of the National Assembly’s Health and Welfare Committee on the 11th, suspicions have been raised that the Ministry of Food and Drug Safety may have provided such preferential treatment to SK Basa. The Ministry of Food and Drug Safety was able to verify the effectiveness of Koreans, and said that there was no problem because the decision was made after expert advice.

Rep. Jong-seong Lee of the Ministry of Food and Drug Safety on the 8th said, “The SK Bioscience clinical trial did not meet the standard of recruiting 10% of Koreans. “he said.

This came to light when it became known that there were exceptions in the guidelines of the Ministry of Food and Drug Safety, which were revised in June this year. Previously, it was ‘recommended that the proportion of Korean subjects be about 10% in a multinational clinical trial’, but it is explained that ‘it can be used as a basis for other statistical guidelines’ was added to the standard.

SK Bioscience received approval for phase 3 clinical trials for the COVID-19 vaccine substance ‘GBP510’ in August. Of the total subjects who participated in the clinical trial, only 2.3% were Koreans.

Minister of Food and Drug Safety Kim Gang-lip said, “Approval of phase 3 clinical trial was a decision after expert advice that there would be no problem if patients with statistical significance that can verify efficacy related to Koreans were recruited.”

In addition, to the point that the approval of the phase 3 clinical trial is not a preference in a situation where the phase 2 clinical trial has not been completed, Director Kim said, “There is no rush with any intention. Under this circumstance, we believe that the justification that the Ministry of Food and Drug Safety should focus on and support the development of a domestic vaccine is sufficient ground,” he emphasized.

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