SK Bioscience COVID-19 Vaccine 'GBP510' Sequential Review Application to UK MHRA

UK Regulatory Authority Targets Conditional Approval
EMA and WHO Approval Applications Also Planned for First Half
Expanded Vaccination Scope Through Additional Clinical Trials
"Preparing for the 'Next Pandemic' with Platform Technology"

[Asia Economy Reporter Lee Gwan-joo] SK Bioscience announced on the 16th that it has submitted sequential review documents for the expedited approval of its self-developed COVID-19 vaccine 'GBP510' to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

MHRA's sequential review is a system introduced to accelerate the evaluation of promising vaccines and therapeutics. Before applying for final approval, data on efficacy, safety, and quality are submitted sequentially for rapid review. The sequential review documents submitted by SK Bioscience include quality data, non-clinical toxicity, efficacy tests, and clinical phase 1/2 data. Additional clinical phase 3 data currently underway will be submitted as soon as they are available. Along with this, SK Bioscience plans to submit GBP510 sequential review documents to the European Medicines Agency (EMA) within the first half of this year and obtain emergency use authorization (EUL) from the World Health Organization (WHO) as well as emergency use authorizations from overseas countries.

GBP510 is a synthetic antigen-type vaccine candidate jointly developed by SK Bioscience and the Institute for Protein Design (IPD) at the University of Washington School of Pharmacy in the United States, utilizing GlaxoSmithKline (GSK)'s adjuvant technology. Clinical phase 3 trials verifying safety and efficacy are currently underway domestically and internationally, and recently, additional clinical trials have been initiated to expand the vaccination range. The plan is to commercialize GBP510 while expanding its use as a booster shot and for children and adolescents. Since it is based on a synthetic antigen method that has been used for a long time in existing vaccines with proven safety and efficacy, it is expected to have less vaccine hesitancy, and its cold chain distribution at 2?8 degrees Celsius and long-term storage capability are expected to encourage vaccinations not only in Korea but also in underdeveloped countries.

Furthermore, SK Bioscience is conducting research to confirm the preventive effect of GBP510 against COVID-19 variants such as Omicron and is building a platform to respond to the 'next pandemic' using GBP510 development technology. Recently, it was confirmed that a booster shot in participants of the GBP510 clinical phase 1/2 trial showed preventive effects against the Omicron virus, and expanded research on this is underway. Additionally, vaccine development targeting 'sarbecovirus,' which includes COVID-19, severe acute respiratory syndrome (SARS) virus, and variants, has also begun.

Jae-yong Ahn, CEO of SK Bioscience, said, “As we enter the endemic era, the need for periodic vaccination and the development of new vaccines against variant viruses continues to be raised. Based on a platform that can overcome the current pandemic and future pandemics, we will expand R&D into various areas and lead the domestic and international vaccine industry.”

This content was produced with the assistance of AI translation services.