SK Bioscience gets final approval for SKYCovione

Ministry of Food and Drug Safety holds final inspection committee to make final decision

Permission for the item COVID-19 Vaccine No.

 

1 developed and manufactured in Korea is imminent.

 

As a result of discussing SKYCovione's safety and effectiveness, the Central Pharmaceutical Review Committee said that it was recognized for the purpose of preventing COVID-19 based on the immunogenic clinical results compared to Vaxzevria, which was already approved, and that the item could be approved.

 

The MFDS (Director Oh Yoo-kyung) explained the progress of item approval for the COVID-19 vaccine SKYCovione (GBP510) developed and manufactured by SK Bioscience in Korea at 10 a.m.

 

on the 27th.

 

SK Bioscience applied for a preliminary review of quality data on April 15, and an application for item permission was received on April 29.

 

A meeting of the Central Pharmaceutical Affairs Review Committee was held at 4 p.m.

 

on the 26th to advise on the safety and effectiveness of SKYCovione.

 

Based on the submitted data such as clinical trial data for SKYCovione, the committee acknowledged the safety and effectiveness of the drug and discussed whether the item permission was appropriate.

 

In particular, experts' comprehensive opinions were exchanged on overall permits, such as overall views on the effectiveness and safety of vaccines and measures to secure safety after approval.

 

As a result of discussing whether SKYCovione's safety and effectiveness were recognized, safety such as abnormal cases that occurred in clinical trials was judged to be acceptable.

 

However, there was an opinion that the predicted adverse reactions in the local and systemic areas were more likely to be caused by vaccinations such as fatigue, muscle pain, headache, chills, fever, joint pain, nausea, vomiting, and diarrhea in adults younger than the first dose.

 

Unforeseen adverse events related to vaccine administration (4 weeks after administration) occurred in about 13.3% (402/3029 patients) of the vaccine group, the main symptoms were injection site hyperplasia, dizziness, pain, etc., and the control group was about 14.6% (145/996).

 

The serious abnormalities were similar to 0.5% (15 cases, 15 cases) in the vaccine group and 0.5% (5 cases, 9 cases) in the control group, and there was 1 rapid progressive glomerulonephritis, which cannot be excluded from vaccine administration, but it was recovering at the time of submission of clinical trial data.

 

In the immunogenicity results comparing already approved Vaxzevria with a control vaccine, neutralization antibodies formed 2.93 times after 14 days of administration every four weeks over the age of 18, and serum conversion rate was 98.06% in the vaccine group and 87.30% in the control group.

 

It was suggested that the overall safety security plan is appropriate, and it is reasonable to observe and evaluate abnormal cases of special interest similar to existing vaccines as a risk management plan after approval.

 

The Ministry of Food and Drug Safety said, "When compiling the opinions of the committee, it was agreed that SKYCovione could be approved." The MFDS received advice from the COVID-19 treatment, vaccine safety, and effectiveness verification advisory group on June 21 to enhance the expertise and objectivity of the COVID-19 vaccine licensing review process.

 

The effectiveness for permission is recognizable, and safety during clinical trials is acceptable, and abnormal cases of special interest should be observed and information should be collected after permission.

 

The MFDS will review SKYCovione's submission data, comprehensively judge expert opinions, efficacy, effectiveness, dosage, and recommendations obtained from the advice of the COVID-19 vaccine safety and effectiveness committee, and hold a final inspection committee to make a final decision.