Skycovione

Last updated

Skycovione
Vaccine description
Target SARS-CoV-2
Vaccine type Protein subunit
Clinical data
Other namesGBP510, Skycovion [1]
Routes of
administration 		Intramuscular

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] [7] [8] It is South Korea's first homegrown COVID-19 vaccine [9] 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. [10] 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. [11]

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. [9] 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. [9]

On June 29, 2022, Skycovione was approved for use in South Korea. [12] The vaccine needs an additional safety review because "the number of participants in Skycovione's trial was only one-tenth of other vaccine trials". [13]

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. [14] Unused doses of the vaccine are likely to be discarded. [15]

In September 2023, SK Bioscience withdrew the application for marketing authorization in the EU. [16] Note: "Page or document not found" now (2024.01.19)

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References

  1. ↑ "EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine". European Medicines Agency (EMA). 18 August 2022. Archived from the original on 19 August 2022. Retrieved 19 August 2022.
  2. ↑ "Two nanoparticle vaccines enter clinical trials – Institute for Protein Design". 2 June 2021. Archived from the original on 19 September 2021. Retrieved 18 August 2021.
  3. ↑ "CEPI funds Phase 3 trial of UW Medicine COVID-19 vaccine". 24 May 2021. Archived from the original on 5 September 2021. Retrieved 5 September 2021.
  4. ↑ "SK COVID-19 Vaccine "GBP510" CEPI "Wave2" (next-generation vaccine)ed as the first development support target". SK Bioscience. 10 December 2020. Archived from the original on 28 July 2021. Retrieved 28 July 2021.
  5. ↑ "CEPI and SK bioscience extend collaboration to develop 'next generation' COVID-19 vaccine". Coalition for Epidemic Preparedness Innovations. 9 December 2020. Archived from the original on 28 July 2021. Retrieved 28 July 2021.
  6. ↑ "Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19)". ClinicalTrials.gov . 11 February 2021. NCT04750343. Retrieved 22 April 2021.
  7. ↑ "Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)". ClinicalTrials.gov . 8 February 2021. NCT04742738. Retrieved 22 April 2021.
  8. ↑ Moon-hee C (11 June 2021). "SK Bioscience's COVID-19 Vaccine Uses Nanoparticle Technology of University of Washington". Business Korea. Archived from the original on 28 July 2021. Retrieved 28 July 2021.
  9. 1 2 3 "'Government to approve SK Bioscience's Covid-19 vaccine this week'". KBR. 27 June 2022. Archived from the original on 1 July 2022. Retrieved 28 June 2022.
  10. ↑ "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" (Press release). SK bioscience. 18 October 2021. Archived from the original on 11 August 2022. Retrieved 20 August 2022.
  11. ↑ "COVID-19 vaccine with IPD nanoparticles seeks full approval – Institute for Protein Design". 29 April 2022. Archived from the original on 29 April 2022. Retrieved 29 April 2022.
  12. ↑ "SK Bioscience gets final approval for Korea's 1st COVID-19 vaccine". The Korea Times . 29 June 2022. Archived from the original on 30 June 2022. Retrieved 30 June 2022.
  13. ↑ "SK Bioscience's Covid-19 vaccine needs additional safety review". KBR. 9 August 2022. Archived from the original on 21 August 2022. Retrieved 20 August 2022.
  14. ↑ "Production of S. Korea's first COVID-19 vaccine suspended". The Korea Herald. 23 November 2022.
  15. ↑ "Unused doses of S. Korea's first homegrown vaccine likely to be discarded". Yonhap News Agency. 23 November 2022.
  16. ↑ "Skycovion: Withdrawn application". European Medicines Agency. 14 September 2023. Retrieved 16 September 2023.


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