The development site of ‘SKYCovione’, Korean Covid-19 vaccine developed by SK Bioscience (SK Bio) was open to the media.
SK Bio invited the media to the Andong L House on August 10th, and opened the production plant of SKYCovione to journalists.
SKYCovione is the ‘Korea’s first’ Covid-19 vaccine using synthetic antigens, under development led by SK Bio, which has financial support from the Bill & Melinda Gates Foundation (BMGF) and the Coalition for Epidemic Preparedness Innovations (CEPI), and applies the antigen technology of the Institute for Protein Design at University of Washington School of Medicine and the adjuvant AS03 of GlaxoSmithKline.
The company explained, “We undertook this vaccine development in February 2020 when the Covid-19 pandemic began, with our social responsibility of responding to virus threatening humans under the mission ‘We Promote Human Health, from Prevention to Cure’.”
In December of the same year, as SK Bio was selected for the ‘Wave2’ (next-generation COVID-19 vaccine) project, which was operated by CEPI with a funding from the BMGF to support differentiated COVID-19 vaccine candidates, the company received a total development cost of US$213.7 million (245 billion won) and commenced global clinical trials.
In August last year, the company entered global phase 3 clinical trials for the first time among COVID-19 vaccines developed in Korea.
Comparative clinical trials with existing COVID-19 vaccines on 4,037 adults aged 18 or older in Korea and 5 countries including Thailand, Vietnam, New Zealand, Ukraine and the Philippines showed an advantage over the control vaccines in immunogenicity and safety.
Based on the clinical trial results, the company obtained product approval from the Korean Ministry of Food and Drug Safety in June, and recently completed an application for conditional product approval from the British Medicines & Healthcare products Regulatory Agency.
SK Bio plans to register on the WHO emergency use list and obtain approval for use in other countries to enter the global market.
An official from SK Bioscience said, “SKYCovione is expected to give new vaccine options to those who are not vaccinated due to concerns over the safety of the COVID-19 vaccine with new technology. Furthermore, we also expect it to contribute to efforts in encouraging vaccination not only in Korea but also around the world, including underdeveloped countries as it can be refrigerated at 2 to 8 degrees Celsius and stored for a long time”.
He added, "We plan to contribute to national policy to prepare for an endemic era without the impact of global supply-demand volatility by providing Korea with an option of a new coronavirus vaccine and securing the vaccine sovereignty”.
Meanwhile, SK Bio will enter phase 3 clinical trials for those aged 12 to 17 to expand the scope of SKYCovione's vaccinations to the youth.
[WIKI KOREA=Kim Sun, Reporter]