"First Domestic COVID-19 Vaccine" ... 2.9 Times More Effective Than AZ and Secures Safety

SK Bioscience's 'Skycovione Multi'
Adverse Reactions Like Muscle Pain More Common in Younger People Than Elderly

With the imminent birth of a COVID-19 vaccine developed, produced, and supplied entirely by a domestic company, the long-emphasized 'vaccine sovereignty' during the pandemic over the past two years has finally been secured. Through vaccine localization, not only has the technological capability and global competitiveness of the domestic pharmaceutical and bio industries been proven, but it has also become possible to produce independently and secure supply amid concerns about the resurgence of COVID-19 and the spread of new variant viruses.

Earlier, the Ministry of Food and Drug Safety announced at the end of April that it had begun the product approval review for SK Bioscience's COVID-19 vaccine, anticipating that if the submitted data were appropriate, approval could be expected as early as June. SK Bioscience has also been confident of approval within the first half of the year based on the results of clinical trials conducted so far.

According to the Central Pharmaceutical Affairs Deliberation Committee on the 27th, SK Bioscience's 'Skycovione Multi' was judged to have higher efficacy compared to AstraZeneca's Vaxzevria, which had been previously approved, used as a comparator vaccine.

In the immunogenicity evaluation, when administered twice to adults at a 4-week interval, the neutralizing antibody titer capable of neutralizing the COVID-19 virus and preventing infection was 2.93 times higher than that of the control group. The seroconversion rate was also confirmed to be 98.06% in the vaccine group, which was 10.76% higher than the 87.30% in the control group.

Considering adverse events occurring during clinical trials, safety was judged to be at an acceptable level and generally similar to the comparator vaccine.

However, it was noted that predicted adverse reactions at local and systemic sites occurred more frequently in younger adults than in the elderly after the first dose rather than the second, suggesting the need for guidance during the first vaccination. Predicted adverse reactions include fatigue, myalgia, headache, chills, fever, arthralgia, nausea/vomiting, and diarrhea. There was one serious adverse drug reaction possibly related to the vaccine?rapidly progressive glomerulonephritis?which was in recovery at the time of clinical trial data submission.

Oh Il-hwan, chairman of the Central Pharmaceutical Affairs Deliberation Committee, explained, "As a result of the review, it was deemed appropriate to observe and evaluate additional cases of special interest adverse reactions similarly to existing vaccines as part of the risk management plan after approval of SK Bioscience's Skycovione. It was recognized as necessary for domestic COVID-19 prevention, and considering the advisory results from the COVID-19 vaccine safety and efficacy verification advisory group, a consensus was reached that product approval is possible."

The Ministry of Food and Drug Safety plans to hold a ‘Final Review Committee’ meeting to make the final decision on the approval of Skycovione Multi by comprehensively considering expert opinions from the Central Pharmaceutical Affairs Deliberation Committee, efficacy and effectiveness, dosage and administration, and recommendations.

Seo Kyung-won, director of the National Institute of Food and Drug Safety Evaluation, said, "SK Bioscience's Skycovione is the first COVID-19 vaccine for which our Ministry of Food and Drug Safety is conducting the world's first approval review, and it is the first domestically developed COVID-19 vaccine produced entirely in Korea from raw materials to finished products." He added, "We plan to make the final approval decision within June and aim for the World Health Organization (WHO) emergency use authorization considering global supply."