[Exclusive] Backdrop to the birth of the first vaccine in Korea...“Development would have been difficult without Shincheonji's blood plasma donation”
✦ Ministry of Food and Drug Safety (MFDS) approves SK Bioscience's new coronavirus vaccine 'Skycobe One Multi' on the 29th
✦ An official from the Korea Disease Control and Prevention Agency (KCDC) says, “I am very grateful to Shincheonji Church for donating their plasma.”
[Chunji Ilbo = Reporter Bo-young Hong] “Without the national standard material for vaccines, there would be no domestic vaccine. I am very grateful to Shincheonji Church for allowing their remaining plasma to be used for the development of a treatment and vaccine for COVID-19, despite their many difficulties at that time.”
The No. 1 novel coronavirus (COVID-19) preventive vaccine has been born in Korea. Finally, Korea has sovereignty over vaccines. It has been about a year and seven months since the first foreign-made COVID-19 vaccine was given to the general public in the UK on December 8, 2020.
It was made known that the national standard materials for making a vaccine demanded the blood plasma from individuals who had recovered from COVID-19. Accordingly, the members of Shincheonji Church of Jesus, the Temple of the Tabernacle of the Testimony, who were responsible for more than 90% of donated plasma at the time, have received belated appreciation for their efforts.
✦ The first vaccine that establishes a healthy and secure system
According to the Ministry of Food and Drug Safety (MFDS) on the 1st, SK Bioscience's 'Skycobe One Multi' has obtained approval as the first domestic COVID-19 preventive vaccine. The MFDS held three advisory meetings and reviewed the prevention effectiveness and safety of the vaccine.
At a briefing on the 29th of last month, Minister of Food and Drug Safety (MFDS) Director Yoo-kyung Oh said, “SK Bioscience has decided to approve the COVID-19 vaccine, for which it has applied for a manufacturing and sales licence. We have become a country that has developed a cure to coronavirus, and we have built a healthy and secure system that can pre-emptively respond to future outbreaks of infectious disease.”
According to an official from the Korea Disease Control and Prevention Agency (KCDC), the national standard materials for vaccine had a significant impact until the first domestic vaccine was born. The national standard for vaccine refers to the serum for which neutralising antibodies for vaccine efficacy are measured. This is plasma containing antibodies from cured people and is used to evaluate efficacy in vaccine clinical trials in the development stage.
The World Health Organization (WHO) sells a certain amount of national standard materials for vaccines for use in vaccine development clinical trials in each country. However, since this amount is only 1ml per year, it is not enough to be used in clinical trials. Therefore, this amount is not used in clinical trials, but is given as a reference point for the making of national standard substances within each country. It is known that 120 to 150 capsules per vial (1.5 ml) were required for only the Phase 3 clinical trial of Skycobe One Multi.
For this reason, a large amount of national standard materials was needed. Moreover, the clinical trial infrastructure was insufficient not only now but also at the time of domestic vaccine development. This is because it was difficult to obtain a subject with a comparative antibody titer. Most people already had immunity due to vaccination. As a result, several domestic pharmaceutical companies halted clinical trials for the treatment and development of a COVID-19 vaccine.
✦ Total plasma donors: 4096
In this situation, donated blood plasma was used. Most of this plasma was donated by members of Shincheonji Daegu Church. As of December 15, 2020, 91.3% of all plasma donors - that is, 3,741 out of 4,096 donors - were Shincheonji members who participated across three rounds of group and individual donations.
The donated plasma was used to develop a treatment for COVID-19 and the research of mutant viruses. However, as the development of plasma treatment stopped in May of last year, plasma was no longer used, leaving about 120 people (50 ml per person, total 60 litres) of plasma.
The Korea Disease Control and Prevention Agency obtained permission from donors to use residual plasma as the national standard material for the development of vaccine clinical trials. In addition, it plans to use it for clinical trials and basic research into the development of vaccines and medical treatment carried out by domestic pharmaceutical companies.
“The amount of international standard material (plasma) supplied by the World Health Organization was limited enough to be used in clinical trials related to domestic treatment and vaccine development,” said Jun-woo Lee, a researcher at the Korea National Institute of Health of the Korea Disease Control and Prevention Agency. “Thanks to those who actively donated plasma, we were able to make the national standard material, which was invaluable in evaluating the efficacy of samples in domestic COVID-19 vaccine clinical trials.”
He added, “I am very grateful to Shincheonji Church for allowing their remaining plasma to be used for the development of a treatment and vaccine for COVID-19, despite their many difficulties at that time.”
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