Skycovione Explained

Type:vaccine
Target:SARS-CoV-2
Vaccine Type:protein
Routes Of Administration:Intramuscular
Synonyms:GBP510, Skycovion[1]

Skycovione is a COVID-19 vaccine candidate developed by SK Bioscience and the Institute for Protein Design of the University of Washington,[2] [3] [4] [5] [6] It is South Korea's first homegrown COVID-19 vaccine[7] and utilizes GSK's AS03 adjuvant technology.

The phase III clinical trial involves 4,037 participants. In April 2022, results of the phase III trial confirmed the vaccine to be safe and effective.[8] It elicited approximately three times more antibodies than the Oxford–AstraZeneca COVID-19 vaccine. The South Korean Government has ordered 10 million doses for domestic use.[9]

The Korean Ministry of Food and Drug Safety released the results of their review on SK Bioscience's Skycovione on June 27, 2022, and said the data was sufficient for approval. According to the Korean Ministry of Food and Drug Safety, vaccine-related adverse events occurred in 13.3% of the vaccine group. In the control group, the adverse event rate was about 14.6%, which was not different from the vaccine group. Serious adverse events occurred in 0.5% in the vaccine group and 0.5% in the control group. There was one adverse event of glomerulonephritis which could not be excluded from vaccine association.

On June 29, 2022, Skycovione was approved for use in South Korea.[10] The vaccine needs an additional safety review because "the number of participants in Skycovione's trial was only one-tenth of other vaccine trials".[11]

In November 2022, the production of SKYCovione was indefinitely suspended because of short demand of the vaccine. South Korean government purchased 10 million doses of SKYCovione of which 600,000 doses released into hospitals. However, only 3,787 shots of them have been administered as of November.[12] Unused doses of the vaccine are likely to be discarded.[13]

In September 2023, SK Bioscience withdrew the application for marketing authorization in the EU.[14] Note: "Page or document not found" now (2024.01.19)

Notes and References

  1. News: EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine . European Medicines Agency (EMA) . 18 August 2022 . 19 August 2022 . 19 August 2022 . https://web.archive.org/web/20220819000216/https://www.ema.europa.eu/en/news/ema-starts-review-conditional-marketing-authorisation-application-skycovion-covid-19-vaccine . live .
  2. Web site: Two nanoparticle vaccines enter clinical trials – Institute for Protein Design. 2 June 2021 . 2021-08-18. 19 September 2021. https://web.archive.org/web/20210919215345/https://www.ipd.uw.edu/2021/06/two-nanoparticle-vaccines-enter-clinical-trials/. live.
  3. Web site: CEPI funds Phase 3 trial of UW Medicine COVID-19 vaccine. 24 May 2021. 5 September 2021. 5 September 2021. https://web.archive.org/web/20210905014211/https://newsroom.uw.edu/news/cepi-funds-phase-3-trial-uw-medicine-covid-19-vaccine. live.
  4. Web site: SK COVID-19 Vaccine "GBP510" CEPI "Wave2" (next-generation vaccine)ed as the first development support target . SK Bioscience . 28 July 2021 . 10 December 2020 . 28 July 2021 . https://web.archive.org/web/20210728045806/https://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=37 . live .
  5. Web site: CEPI and SK bioscience extend collaboration to develop 'next generation' COVID-19 vaccine . Coalition for Epidemic Preparedness Innovations . 28 July 2021 . 9 December 2020 . 28 July 2021 . https://web.archive.org/web/20210728045806/https://cepi.net/news_cepi/cepi-and-sk-bioscience-to-develop-next-generation-covid-19-vaccine/ . live .
  6. News: Moon-hee C . SK Bioscience's COVID-19 Vaccine Uses Nanoparticle Technology of University of Washington . 28 July 2021 . Business Korea . 11 June 2021 . 28 July 2021 . https://web.archive.org/web/20210728045805/http://www.businesskorea.co.kr/news/articleView.html?idxno=69418 . live .
  7. Web site: 2022-06-27 . 'Government to approve SK Bioscience's Covid-19 vaccine this week' . 2022-06-28 . KBR . 1 July 2022 . https://web.archive.org/web/20220701160200/http://www.koreabiomed.com/news/articleView.html?idxno=13993 . live .
  8. SK bioscience and GSK's Adjuvanted COVID-19 Vaccine Candidate Meets Coprimary Objectives in a Phase III Study; Biologics License Application Submitted for SKYCovione (GBP510/GSK adjuvant) in South Korea . SK bioscience . 18 October 2021 . 20 August 2022 . 11 August 2022 . https://web.archive.org/web/20220811031614/https://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=125& . live .
  9. Web site: COVID-19 vaccine with IPD nanoparticles seeks full approval – Institute for Protein Design . 29 April 2022 . 2022-04-29 . 29 April 2022 . https://web.archive.org/web/20220429220233/https://www.ipd.uw.edu/2022/04/covid-19-vaccine-with-ipd-nanoparticles-seeks-full-approval/ . live .
  10. Web site: 2022-06-29 . SK Bioscience gets final approval for Korea's 1st COVID-19 vaccine . 2022-06-30 . . 30 June 2022 . https://web.archive.org/web/20220630085351/https://www.koreatimes.co.kr/www/tech/2022/06/779_331885.html . live .
  11. Web site: SK Bioscience's Covid-19 vaccine needs additional safety review . KBR . 9 August 2022 . 20 August 2022 . 21 August 2022 . https://web.archive.org/web/20220821043504/http://www.koreabiomed.com/news/articleView.html?idxno=14354 . live .
  12. Web site: Production of S. Korea's first COVID-19 vaccine suspended . November 23, 2022 . .
  13. Web site: Unused doses of S. Korea's first homegrown vaccine likely to be discarded . November 23, 2022 . .
  14. Web site: 2023-09-14 . Skycovion: Withdrawn application . 2023-09-16 . European Medicines Agency . en.

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