bioscience will accelerate to apply for emergency use listing (EUL) to the
World Health Organization (WHO)
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, today announced that the Company has submitted an application for a Conditional Marketing Authorization (CMA) of the COVID-19 vaccine, ‘SKYCovion™’ to the European Medicines Agency (EMA), following U.K. submission. SK bioscience also plans to quickly apply for Emergency Use Listing (EUL) to the World Health Organization (WHO). If the EUL is obtained, SKYCovion™ will be made available to the COVAX Facility for procurement and equitable allocation worldwide, if required.
SKYCovion™ is a self-assembled nanoparticle vaccine
targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the
parental SARS-Cov-2, jointly developed with the Institute for Protein Design
(IPD) at the University of Washington School of Medicine with combination of
GSK’s pandemic adjuvant. The development of SKYCovion™ has been supported by
funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic
Preparedness Innovations (CEPI) with support from the European Union (EU)’s
Horizon 2020 Programme.
SKYCovion™ is based on recombinant protein vaccine
technology which has been used for development of current vaccines including
influenza, and HPV vaccines. The results of the global Phase III clinical trial
showed that SKYCovion™ induces neutralizing antibody responses and had an
acceptable safety and the reactogenicity profile compared to the control
vaccine, AstraZeneca’s Vaxzevria™, used in the study. The results of extended
phase I/II clinical trials also showed that there was a high immune response to
the Omicron variant BA.1 after a booster of SKYCovion™. The clinical trial was
conducted in cooperation with 16 institutions, including Center for Vaccine of
Korea National Institute of Health, International Vaccine Institute (IVI), and
Korea University Guro Hospital.
Ahn Jae-yong, CEO
of SK bioscience, said, "The repeated emergence of new COVID-19 variants
are still threatening our daily lives,” adding, "Our aspiration remains to
fulfill our role and responsibility as a global vaccine hub by entering
overseas markets for self-developed vaccines and developing new platforms to
respond to the pandemic."
bioscience plans to develop a combination vaccine candidate that applies for
both flu and COVID-19 at once using the SKYCovion™ platform, and a universal
vaccine candidate effective against the Sarbecovirus group that includes
COVID-19 and its variants to prepare for endemic COVID-19.