Company submitted an application for CMA of SKYCovione™ to MHRA and EMA, followed by EUL to WHO.
approved, Company will accelerate an emergency use authorization with global
[2022, Sept 8] Seoul, South Korea- 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 Emergency Use Listing (EUL) application to the World
Health Organization for ‘SKYCovione™’, South Korea’s first homegrown COVID-19
The WHO EUL is a risk-based procedure for assessing
and listing unlicensed vaccines, therapeutics, and in vitro diagnostics with
the aim of expediting the availability of these products to people affected by
a public health emergency. As of August 2022, there are 11 COVID-19 vaccines
are listed on the EUL.
In July, the company also has applied for a Conditional
Marketing Authorization (CMA) of SKYCovione™ (SKYCovion™ in Europe) to the Medicine
and Healthcare products Regulatory Agency (MHRA) and the European Medicines
Agency (EMA). If approved by global regulatory authorities, SKYCovione™ will be
made available to COVAX for allocation worldwide, at its discretion.
SKYCovione™, a recombinant protein vaccine with
GSK’s pandemic adjuvant, can be stored between 2-8 degrees Celsius, making it
suitable to use in lower-middle-income countries where deep freeze facilities
are not available.
Jaeyong Ahn, CEO of SK bioscience said, "SKYCovione™,
selected as the first vaccine candidate for the project Wave 2 operated by the Coalition
for Epidemic Preparedness Innovations (CEPI) from the beginning of development,
is now ready for the global market,” adding, “We will secure the vaccine
sovereignty and respond to the COVID-19 endemic stage by accelerating the emergency
use authorization from global regulatory authorities.”
SKYCovione™ 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 SKYCovione™ 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 global Phase III clinical trial
showed that SKYCovione™ induced neutralizing antibody responses against the
SARS-CoV-2 parental strain and had a standard safety
and reactogenicity profile. In addition, SKYCovione™
also showed cross-neutralizing activity against Omicron variant BA.1 when
administered as a booster. The clinical trials were conducted in cooperation
with 16 institutions, including Korea University Guro Hospital and International
Vaccine Institute (IVI), and supported by Center for Vaccine Research at Korea
National Institute of Health.