If approved, SK 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 dedicated to promoting human health from prevention to cure
across the globe, announced that the company applied for a Conditional
Marketing Authorization (CMA) of the joint-developed COVID-19 vaccine, ‘SKYCovion™’ to the UK Medicines and Healthcare Products Regulatory Authority
SKYCovion™ has been submitted to an application for rolling review by the MHRA
since March. SK bioscience additionally applied the recently secured Phase III
clinical data of SKYCovion™ for a formal conditional approval.
Following UK submission, SK bioscience also plans
to quickly apply for conditional approval to the European Medicines Agency
(EMA), 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.
Jaeyong Ahn, CEO of SK bioscience said, “With this
submission, we have taken a further step to make available a jointly developed
Korean COVID-19 vaccine with high immunogenicity and safety around the world.
Starting with the UK application, we hope to introduce Korea´s technology to
the global vaccine market and achieve our global health aspirations.”
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 the Coalition for
Epidemic Preparedness Innovations (CEPI), with support from the European
Union’s Horizon 2020 Programme.
The results of the Phase III clinical trial,
collected in 4,037 adults over 18-year-old, showed that SKYCovion™ induced
neutralizing antibody responses, against the SARS-CoV-2 parental strain. The
clinical trial was conducted in cooperation with 16 institutions, including
Korea University Guro Hospital and IVI (International Vaccine Institute), a
non-profit international organization.
SKYCovion™ also showed cross-neutralizing activity against
Omicron variant BA.1 when administered as a booster. The results of the Phase
I/II clinical trial, conducted with 81 healthy adults who received a booster
dose of SKYCovion™ 7 months after the second dose of SKYCovion™, showed that
the neutralizing antibody titres against the Omicron variant BA.1 were 25 times
the titers observed two weeks after two primary doses.
SK bioscience is currently conducting heterologous
and homologous booster clinical trials of SKYCovion™. Further, SK bioscience plans
to conduct a research study to assess the preventive effect of SKYCovion™
against subvariants of Omicron by utilizing the SKYCovion™’s platform.
Separately, SK bioscience initiated the development
of a universal vaccine candidate effective for the entire Sarbecovirus group to
establish a broader protection system against COVID-19 variants and SARS in the