Medicine:Skycovione
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | Protein subunit |
| Clinical data | |
| Other names | GBP510, 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. Should the trial confirm GBP510's efficacy and safety, the vaccine is expected to be approved in the first half of 2022.[10][11][12][13]
In April 2022, results of the phase III trial confirmed the vaccine to be safe and effective.[14] It elicited approximately three times more antibodies than the Oxford–AstraZeneca COVID-19 vaccine. Should the vaccine be approved by health regulators, it will be distributed via the COVAX program. The South Korean Government has ordered 10 million doses for domestic use.[15]
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.[16] The vaccine needs an additional safety review because "the number of participants in Skycovione's trial was only one-tenth of other vaccine trials".[17]
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.[18] Unused doses of the vaccine are likely to be discarded.[19]
References
- ↑ "EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine". 18 August 2022. https://www.ema.europa.eu/en/news/ema-starts-review-conditional-marketing-authorisation-application-skycovion-covid-19-vaccine.
- ↑ "Two nanoparticle vaccines enter clinical trials – Institute for Protein Design". https://www.ipd.uw.edu/2021/06/two-nanoparticle-vaccines-enter-clinical-trials/.
- ↑ "CEPI funds Phase 3 trial of UW Medicine COVID-19 vaccine". 24 May 2021. https://newsroom.uw.edu/news/cepi-funds-phase-3-trial-uw-medicine-covid-19-vaccine.
- ↑ "SK COVID-19 Vaccine "GBP510" CEPI "Wave2" (next-generation vaccine)ed as the first development support target". SK Bioscience. 10 December 2020. https://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=37.
- ↑ "CEPI and SK bioscience extend collaboration to develop 'next generation' COVID-19 vaccine". Coalition for Epidemic Preparedness Innovations. 9 December 2020. https://cepi.net/news_cepi/cepi-and-sk-bioscience-to-develop-next-generation-covid-19-vaccine/.
- ↑ "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.
- ↑ "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.
- ↑ "SK Bioscience's COVID-19 Vaccine Uses Nanoparticle Technology of University of Washington". Business Korea. 11 June 2021. http://www.businesskorea.co.kr/news/articleView.html?idxno=69418.
- ↑ 9.0 9.1 9.2 "'Government to approve SK Bioscience's Covid-19 vaccine this week'". 2022-06-27. http://www.koreabiomed.com/news/articleView.html?idxno=13993.
- ↑ "SK Bioscience advances first South Korean-developed COVID-19 vaccine to late-stage testing". https://www.bioworld.com/articles/510281-sk-bioscience-advances-first-south-korean-developed-covid-19-vaccine-to-late-stage-testing?v=preview.
- ↑ "SK Bioscience Starts to Administer COVID-19 Vaccines to Subjects in Phase 3 Trial". 31 August 2021. http://www.businesskorea.co.kr/news/articleView.html?idxno=75316.
- ↑ SK Bioscience Co., Ltd. (2021-10-14). A Phase III, Randomized, Active-controlled, Observer-blind, Parallel-group, Multi-center Study to Assess the Immunogenicity and Safety of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine Adjuvanted With AS03 (GBP510) in Adults Aged 18 Years and Older. International Vaccine Institute, GlaxoSmithKline, Coalition for Epidemic Preparedness Innovations. https://clinicaltrials.gov/ct2/show/NCT05007951. Retrieved 9 November 2021.
- ↑ "IVI and SK bioscience Complete Recruitment for Phase III Clinical Trial of SKBS' COVID-19 Vaccine". 18 January 2022. https://www.ivi.int/ivi-and-sk-bioscience-complete-recruitment-for-phase-iii-clinical-trial-of-skbs-covid-19-vaccine/.
- ↑ "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.
- ↑ "COVID-19 vaccine with IPD nanoparticles seeks full approval – Institute for Protein Design". https://www.ipd.uw.edu/2022/04/covid-19-vaccine-with-ipd-nanoparticles-seeks-full-approval/.
- ↑ "SK Bioscience gets final approval for Korea's 1st COVID-19 vaccine". 2022-06-29. https://www.koreatimes.co.kr/www/tech/2022/06/779_331885.html.
- ↑ "SK Bioscience's Covid-19 vaccine needs additional safety review". 9 August 2022. http://www.koreabiomed.com/news/articleView.html?idxno=14354.
- ↑ "Production of S. Korea's first COVID-19 vaccine suspended". The Korea Herald. November 23, 2022. https://www.koreaherald.com/view.php?ud=20221123000652.
- ↑ "Unused doses of S. Korea's first homegrown vaccine likely to be discarded". Yonhap News Agency. November 23, 2022. https://en.yna.co.kr/view/AEN20221123006100320.
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