The European Medicines Agency (EMA) has begun an evaluation of a conditional marketing authorization application for the Skycovion (GBP510) COVID-19 vaccine candidate from SK Chemicals GmbH.
Skycovion is a recombinant protein-based vaccine with adjuvant from GSK.
In its filing, SK Chemicals provided data on how efficacious the vaccine is at creating antibodies against wild-type COVID-19. In addition, the company shared safety and quality data with the EMA.
Skycovion won approval for the vaccine in South Korea in June.
After the Committee for Medicinal Products for Human Use (CHMP) reviews the application, the European Commission will make a legally binding decision.
A unique vaccine
Skycovion is a recombinant protein-based vaccine based on the genetically produced modified spike protein of the Wuhan stream of SARS-CoV-2. The vaccine uses nanoparticles to encode for the spike protein.
SK Chemicals is headquartered in Seoul, South Korea.
The company aims to make the vaccine available through the COVAX Facility.
The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, and the European Union’s Horizon 2020 Programme all contributed to the development of the Skycovion vaccine.
SK Chemicals jointly developed the vaccine in collaboration with the Washington School of Medicine.
An extended Phase 1/2 clinical trial demonstrated that the vaccine generates a high immune response to the Omicron variant BA.1.
The company is also seeking marketing authorization for the vaccine from the UK Medicines and Healthcare Products Regulatory Authority (MHRA).
“The repeated emergence of new COVID-19 variants are still threatening our daily lives,” said Ahn Jae-yong, CEO of SK bioscience, in a press release. “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.”
Looking to the future
The company intends to develop a combined flu/COVID-19 vaccine based on its Skycovion platform. It is also planning to develop a universal vaccine candidate that targets the Sarbecovirus group, including COVID-19.
In related news, the U.S. recently announced it plans on transitioning responsibility for COVID-19 vaccine distribution to the private market.