The Ministry of Food and Drug Safety (MFDS) released the results of expert deliberation on SK Bioscience’s new coronavirus (corona 19) vaccine ‘Skycobi One Multi-Zoo (development name: GBP510)’. As a result of reviewing the submitted data, it is explained that the product conforms to the approval of the product.
However, it is expected that the fairness controversy will arise as the decision to approve the drug is actually being formalized before going through the final inspection committee, which is the last stage of the triple advisory process for the COVID-19 treatment and vaccine.
On the 27th, the Ministry of Food and Drug Safety (Director Yoo-kyung Oh) disclosed the status of the Skycobe One multi-drug product approval review through an online briefing. The Ministry of Food and Drug Safety held the Central Pharmacist Review Committee on the 26th.
Yoohwan Oh, chairman of the Central Pharmacopoeia (Catholic University of Medicine), who attended the briefing, said, “After discussing whether to recognize the safety and effectiveness of this drug, based on the immunogenicity clinical results compared to the previously licensed Vaxzebria, it was When the necessity was recognized and the results of the consultations of the COVID-19 vaccine safety and effectiveness verification advisory group were combined, it was concluded that product approval was possible.”
Chairman Yoo Hwan said, “We judged safety issues such as adverse events in clinical trials to be at an acceptable level. The incidence of predicted cases due to inoculation was high, such as muscle pain, headache, chills, fever, joint pain, nausea/vomiting, and diarrhea. It is the opinion that guidance is necessary for the first vaccination.”
Accordingly, the Ministry of Food and Drug Safety reviewed the submitted data for Skycobi One Multi-drug, and provided expert opinions, efficacy and effect (plan), usage and dosage (plan), After comprehensively judging recommendations, he said that the ‘Final Inspection Committee’ will be held to make a final decision on whether to grant permission.
However, the problem is that the Ministry of Food and Drug Safety has effectively formalized the decision to approve Skycobi One Multi-juice along with the announcement of the results of this central review.
In response to a reporter’s question about the final approval date, Suh Kyung-won, director of the Food and Drug Administration, said, “It is difficult to say the final approval date. It is because the final inspection committee has not yet been held.
This is a glimpse into the fact that the Ministry of Food and Drug Safety has actually decided to approve Skycobi One multi-juice.
When asked about the specific date of the final approval, Director Seo Kyung-won also expressed his will to advance the approval schedule, saying, “I talked about the final approval, including the holding of the final inspection committee.”
Director Suh Kyung-won said, “Skycobi One Multi is meaningful in that it is the first self-developed COVID-19 vaccine in Korea, from raw materials to finished products.”
However, in order for Skycobi One Multi to be used for domestic vaccination even after obtaining product approval, the clinical results of the current booster vaccination (booster shot) must be proven.
When asked whether Skycobi One multi-injection can be used as a vaccine for the fourth dose in preparation for a second wave of COVID-19 this fall, Director Seo Kyung-won answered, “This is an area that needs discussion with the Korea Centers for Disease Control and Prevention.”
Director Seo Kyung-won said, “Clinical trials are ongoing to see if additional vaccinations (booster shots) are possible. In the case of efficacy against omicron mutation, it was confirmed that the effect was similar to that of the existing coronavirus when the third inoculation was administered.”
Meanwhile, at this meeting of the Central Pharmacist Review Committee, 11 standing members of the Biological Pharmaceuticals Subcommittee, a specialized subcommittee for reviewing the safety and effectiveness of vaccines, 4 advisors to verify the safety and effectiveness of the COVID-19 vaccine, and 1 expert recommended by the Korean Medical Association 16 external experts were in attendance.
In addition, seven people including the general review team, clinical review team, non-clinical review team, and quality review team of the vaccine review team of the ‘Corona 19 Crisis Response Support Headquarters’ inside the Ministry of Food and Drug Safety attended.
The Ministry of Food and Drug Safety (MFDS) additionally formed a ‘Covid-19 Vaccine Safety and Efficacy Verification Advisory Group’ and a ‘Final Inspection Committee’ when reviewing the approval of a COVID-19 vaccine or treatment, and is undergoing a three-fold advisory process.
According to the announcement on the same day, unpredicted adverse events related to vaccine administration (investigation for 4 weeks after administration) occurred in about 13.3% (402/3,029 patients) of the vaccine group, and the main symptoms were pruritus at the injection site, dizziness, and pain. etc. The control group occurred in about 14.6% (145/996 patients), so there was no difference.
The reported ‘serious adverse events’ were similar in 0.5% of the vaccine group (15 patients, 15 cases) and 0.5% of the control group (5 patients, 9 cases). There was one case of rapidly progressive glomerulonephritis.
Regarding the occurrence of rapidly progressive glomerulonephritis, Chairman Yoo Hwan said, “He was recovering at the time of submission of clinical trial data,” and “we are continuously checking.”
In terms of effectiveness, in the immunogenicity results comparing the licensed Vaxzebria strain as a control vaccine, the neutralizing antibody titer was formed 2.93 times after 14 days of administration twice at an interval of 4 weeks or older over the age of 18, and the seroconversion rate was 98.06% in the vaccine group; It was confirmed as 87.30% of the control group.
Accordingly, the Central Pharmacopoeia judged that the immunogenicity results for approval were acceptable, and recommended that the vaccine preventive effect data be submitted after approval.
