[현장연결] AstraZeneca Corona 19 Vaccine First Approval in Korea… Including 65 years or older
The Ministry of Food and Drug Safety announces the results of the AstraZeneca Corona 19 Vaccine Final Inspection Committee meeting.
Let’s listen to it.
[김강립 / 식품의약품안전처장]
The Ministry of Food and Drug Safety held a final inspection committee including an external expert today and decided to approve the product under the condition of submitting the results of additional clinical trials for AstraZeneca Korea Co., Ltd. COVID19 vaccine strain applied for permission on January 4, 2021 I did it.
AstraZeneca Vaccine is a virus vector vaccine that carries the corona 19 virus surface antigen gene into an adenovirus that only infects chimpanzees, produces it in culture, and delivers it into human cells.
The delivered corona antigen gene synthesizes antigen proteins in the body to induce the production of neutralizing antibodies, and when the corona 19 virus enters the human body, the virus is removed.
The efficacy and effect of this product is to prevent Corona 19 in people 18 years of age or older, and the dosage is 0.5mm each intramuscular injection twice within a period of 4 to 12 weeks.
This vaccine is manufactured by consigning Korea AstraZeneca to SK Bioscience, a domestic pharmaceutical company, and is the first Corona 19 vaccine to be licensed in Korea. Conditional approval or emergency use approval is obtained from 50 governments around the world including EMA of the European Medicines Agency. I have received it.
On January 4, 2021, the Ministry of Food and Drug Safety received an application for product permission for AstraZeneca vaccine, and it has been thoroughly reviewed based on scientific evidence, putting safety first.
The safety and effectiveness verification period has been secured as much as possible by reviewing the data that can be reviewed before the application for permission for this product is received.
The evaluation team dedicated to the approval of the Corona 19 vaccine, composed of the highest expert reviewers within the Ministry of Food and Drug Safety, was intensively reviewed.
In particular, in terms of quality, we evaluated the quality equivalence between the products consigned to SK Bioscience and products produced in Europe.
In addition, in order to evaluate whether the quality of this product is equipped with facilities and management systems that can be consistently produced, on-site investigations were conducted, and in order to confirm the safety of clinical trial subjects and the reliability of the test results, a survey of the clinical trial sponsor was also conducted. It has been done without a hitch.
The Ministry of Food and Drug Safety went through a triple consultation procedure of the Verification Advisory Group, the Central Pharmacist Review Committee, and the Final Inspection Committee in order to increase the expertise and objectivity of the corona19 vaccine approval process.
Meanwhile, on January 31st, we consulted with the Verification Advisory Group and the Central Pharmacy Review Committee on February 4th, and held a final inspection committee to decide whether to approve the AstraZeneca vaccine at 10 am today.
In today’s meeting, the final stage of the COVID-19 vaccine approval process, three external experts, including Chairman Yu-hwan of the Central Pharmacy Review Committee, and five people from the Food and Drug Administration attended.
The final inspection committee comprehensively reviewed the results of the KFDA review and the previous two consultations, and respected the advisory opinions of the Central Pharmacy Review Committee, under the condition of submitting the results of clinical trials in the United States after approval. You have decided to approve
This is an in-depth review of the data necessary for the approval review including clinical trials and comprehensively reviewing the results of on-site investigations, acknowledging the safety and effectiveness.
First, let me tell you the results of the safety review.
The Final Inspection Committee judged that most of the adverse events reported in relation to safety were predicted adverse events related to vaccine administration and were generally good.
The safety evaluation was conducted on 23,745 subjects over 18 years of age in four clinical trials in the UK, Brazil, and South Africa. In general, very common abnormal cases were pain at the injection site, hot sensation, and most of the symptoms were mild. Moderately disappeared within a few days after vaccination.
There were no adverse events such as anaphylaxis reactions and worsening corona symptoms, which may appear as hypersensitivity reactions after vaccine administration.
There were no significant drug-related adverse events in the elderly over the age of 65, and the incidence of predicted or unpredicted adverse events was similar or low compared to the adult population.
Based on these results, the Final Inspection Committee determined that the overall safety of the vaccine was good.
However, there was an opinion that monitoring is necessary after permission for the occurrence of nervous system-related abnormalities, including transverse myelitis, and plans to additionally reflect such abnormal cases as reported in the future.
Next, I will tell you the results of the evaluation on effectiveness.
The preventive effect was evaluated on 8,895 people 18 years of age or older who were negative for the COVID-19 virus in two clinical trials, including the UK and Brazil, and 27 people in the vaccine group and 71 people in the control group were diagnosed with COVID-19 in the vaccine group and the control group. It was found to be about 62%, which is the result of satisfying domestic and international standards related to the evaluation of the effectiveness of the COVID-19 vaccine such as WHO.
The final review committee accepted the results of the two previous consultations on the appropriateness of the vaccine administration dose and administration interval, and decided to authorize the standard dose and administration interval, which confirmed effectiveness in the planned clinical trial.
Regarding the use of senior citizens aged 65 or older, the same efficacy and effect as the results of consultations so far have been approved for those over the age of 18, including those over 65.
However, it has been decided to add a statement in the precautions for use that the use for the elderly over 65 should be decided carefully.
This means that there is no problem in terms of safety and immune response to the elderly over 65 years of age, but the number of elderly clinical participants is limited to 660, so the doctor should sufficiently determine the benefits of vaccination according to the condition of the subject when vaccination for the elderly. is.
In addition, the Central Pharmacist Review Committee recommended that the Korea Centers for Disease Control and Prevention Vaccination Committee discuss measures for vaccination over 65 years of age.
As with the opinion of the verification team and the Central Pharmacy Review Committee regarding vaccination of pregnant and nursing mothers, vaccination is possible if the benefit from the use of the vaccine exceeds the risk, but it was determined that vaccination during pregnancy is not recommended as a preventive measure.
For nursing mothers, it is not known whether this drug is secreted into breast milk.
The Ministry of Food and Drug Safety has concentrated all its capabilities to thoroughly verify the safety and effectiveness and approved the Corona 19 vaccine for the first time in Korea.
The Ministry of Food and Drug Safety will ensure that the results of ongoing clinical trials can be submitted as quickly as possible even after the product is approved, and cooperate with relevant ministries to reinforce the inspection system for abnormal cases after vaccination, and through thorough monitoring and a rapid response system for abnormal cases. We will do our best to ensure that people receive the vaccine with confidence.
Thank you.
Yonhap News TV article inquiries and reports: katok/line jebo23
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