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European authorities begin review of Skycovion COVID-19 vaccine candidate

By Brian Buntz | August 19, 2022

SkycovionThe 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.


Filed Under: Infectious Disease
Tagged With: covid-19, SK Chemicals, Skycovion
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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