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May 2, 2022

SK bioscience-GSK’s Covid-19 vaccine meets Phase III trial’s coprimary goals

The companies have submitted a BLA for SKYCovione to the Korean MFDS on obtaining positive Phase III results.

SK bioscience and GlaxoSmithKline (GSK) have reported that their recombinant, protein-based, Covid-19 vaccine candidate, SKYCovione (GBP510/GSK adjuvant) met the coprimary goals in the Phase III clinical trial.

A self-assembled nanoparticle vaccine candidate, SKYCovione acts on the receptor-binding domain of the Spike protein of the SARS-CoV-2 virus.

The vaccine candidate is also adjuvanted with the pandemic adjuvant of GSK.

Furthermore, the companies have submitted a biologics license application (BLA) for SKYCovione to the Korean Ministry of Food and Drug Safety (KMFDS) following the results.

An advanced purchase agreement is in place with Korea CDC to deliver ten million doses of the vaccine.

In August last year, the companies commenced the Phase III trial to evaluate the safety and immunogenicity of the vaccine.

SK bioscience carried out a Phase III clinical trial enrolling 4,037 adult subjects aged over 18 years in Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea. 

According to the findings, the vaccine was found to have enhanced neutralising antibody titres compared with AstraZeneca’s Covid-19 vaccine, Vaxzevria. 

In addition, the SKYCovione vaccine was demonstrated to have a clinically favourable safety profile with most of the adverse reactions following vaccination being found to be mild or moderate.

Two weeks following the second dose, this vaccine also had 2.93 times superior neutralising antibody response against the SARS-CoV-2 parental strain versus the control vaccine. 

Nearly 98.06% of subjects in the SKYCovione arm were seroconverted compared to 87.30% in the control arm.

GSK Vaccines president Roger Connor said: “As the Covid-19 pandemic continues to evolve, a variety of vaccines will be needed to meet the health needs across the globe, including temperature stable vaccines like the SK/GSK vaccine candidate. 

“These immunogenicity and safety data confirm the important role that our adjuvant technologies play in vaccine development.”

SK bioscience plans to seek an emergency use listing (EUL) from the World Health Organization (WHO) and additional authorisations from various regulatory authorities globally.

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