South Korea’s homegrown Covid-19 vaccine candidate developed by SK bioscience has received an approval recommendation from an expert advisory panel, making a step closer to commercial launch, according to the Ministry of Food and Drug Safety on Monday.

The vaccine codenamed GBP510 is ready for rollout with independent technology for all production value streams from raw materials to filling and packaging.

Approval of the vaccine candidate also known as SKYCovione was recommended during a meeting of the ministry’s Central Pharmaceutical Review Committee held on Sunday based on safety and efficacy data from all three phases of its clinical trial.

SKYCovione’s recommended dosage is two doses given four weeks apart. This recombinant-protein vaccine jointly developed with the Institute for Protein Design at the University of Washington can be stored at 2 to 8 Celsius degrees unlike mRNA vaccines that require very low temperature storage.

In a Phase 3 clinical trial in some 4,000 adults in six countries, including South Korea, SKYCovione demonstrated superiority to AstraZeneca’s comparator vaccine in terms of immunogenicity and seroconversion. The safety profile was comparable to that of AstraZeneca’s with expected adverse reactions such as fatigue, muscle pain, headache, chills, fever, joint pain, nausea/vomiting, and diarrhea. The expert panel recommended a regulatory follow-up on those side effects after marketing approval.

The ministry said it will soon decide whether to approve the vaccine candidate based on the panel’s opinions.

By Pulse

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