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July 14, 2022

SK bioscience Covid-19 vaccine active against BA.1 variant in Phase I/II trial

SKYCovione was jointly developed with the University of Washington School of Medicine’s Institute for Protein Design.

SK bioscience has reported that the first Korean developed vaccine for Covid-19, SKYCovione, demonstrated cross-neutralising activity against Omicron variant BA.1.

The development was observed following administration of booster shot approximately seven months after the primary series.

A Phase I/II clinical trial was carried out in 81 healthy adult subjects who received a booster SKYCovione dose seven months after the second dose.

In this trial, it was observed that the neutralising antibody titres against the Omicron variant were 25 times the titres right after the second dose, and 72 times seven months after the same dose.

Authorised by the Korean Ministry of Food and Drug Safety (KMFDS), SKYCovione was developed through worldwide network cooperation led by SK bioscience.

It was jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine and contains the pandemic adjuvant from GlaxoSmithKline (GSK).

Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) provided funding for SKYCovione development.

Based on all clinical trial data available, the vaccine was found to have an acceptable safety profile.

Following injection, most of the adverse reactions that occurred were mild or moderate and transient.

SK Bioscience CEO Jaeyong Ahn said: “As the world slowly recovers its daily life after the long Covid-19 pandemic, new variants are constantly threatening humanity.

“We will make utmost efforts to prepare for the endemic by accelerating the development of polyvalent vaccines and universal vaccine based on various platforms in addition to conducting various clinical trials of SKYCovione.”

The company is also conducting clinical trials of booster dose for participants in the recent Phase III clinical trial as well as for those who have been vaccinated with other approved vaccines in Korea.

In August last year, SK bioscience announced a global Phase III clinical trial of its Covid-19 vaccine candidate, GBP510, which yielded positive interim results in a Phase I/II trial.

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