Stored at -25 to 15℃ for 24 months… Conditionally approved in 30 countries, emergency approval in the United States, etc.
Conditions for submission of the Ministry of Food and Drug Safety, the final report on clinical trial results, etc.
The Ministry of Food and Drug Safety announced that it has decided to approve the item for the Corona 19 vaccine (COVID-19 vaccine Jansenju) once inoculated on 7 days. Conditions for submitting the final report of clinical trial results were attached.
The Corona 19 vaccine, which has been approved for domestic imports, is the third following Korea AstraZeneca (Korea AstraZeneca COVID-19 vaccine stock) on February 10 and Pfizer Korea (Cominati) on March 5.
‘Covid-19 vaccine Janssen’ is a viral vector vaccine developed by Janssen, USA. The corona 19 virus surface antigen gene is recombined, put into human adenovirus, and injected into the body to synthesize an antigen protein. By inducing the production of neutralizing antibodies, this protein neutralizes and removes the virus when it enters the human body.
Corona 19 is prevented in those over 18 years of age, and 0.5 mL is given once. Storage conditions are at -25~15℃ for 24 months.
‘Covid-19 vaccine Jansenju’ was granted conditional approval in 30 countries including Europe (EMA, 27 countries), Switzerland, Canada and Saudi Arabia, and emergency use approval in 5 countries in the United States, Bahrain, Jordan, Qatar, and the African Union. .
■ Progress of approval review
Janssen Korea Co., Ltd. applied for permission for import items to the Ministry of Food and Drug Safety on February 27th.
The Ministry of Food and Drug Safety has secured the maximum safety and effectiveness verification period by reviewing data that can be reviewed in advance prior to receipt of an application for a license for imported products, and formed a’corona 19 treatment/vaccine approval review team’ with expert reviewers to conduct non-clinical and clinical trials.・It was revealed that it has intensively screened the materials necessary for permission, such as quality.
Non-clinical examination review is an efficacy test that looks at the effect of a vaccine in animals (viral neutralizing titer, immune response, symptoms, etc.), a pharmacokinetic test that looks at the distribution of drugs, and a toxicity test that confirms the toxicity caused by drugs (repeated dose toxicity, reproductive toxicity, etc.). Etc.).
Clinical trial review was conducted in the United States and Belgium (Phase 1 and 2): 1 clinical trial, Japan (Phase 1), 1 multi-country (Phase 2) such as Germany, and 8 countries including the United States (Phase 3, USA). A total of four cases were reviewed, including one multinational clinical trial conducted in Argentina, Brazil, South Africa, Peru, Chile, Colombia, and Mexico. For safety and effectiveness, we looked at phase 3 clinical trials conducted in the United States and elsewhere.
The quality review was evaluated through data review such as manufacturing method, standard and test method.
■ Progress of the triple advisory process
The Ministry of Food and Drug Safety passed the’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ meeting on March 28 and the’Central Pharmacy Review Committee’ on April 1 to enhance the expertise and objectivity of the Corona 19 vaccine approval process. On the 7th, the Ministry of Food and Drug Safety had held a’final inspection committee’ to decide whether to make a final decision. The final inspection committee was attended by three external experts, including the chairman of the Central Pharmacy Review Committee, Yoo-hwan, and five internal members including the head of the Ministry of Food and Drug Safety.
The final inspection committee decided to approve the product for’Covid-19 vaccine Jansenju’ under the condition of comprehensively reviewing the review results of the Ministry of Food and Drug Safety and submitting the final report of clinical trial results after approval.
The Ministry of Food and Drug Safety said, “The safety and effectiveness have been acknowledged by comprehensively reviewing the data necessary for clinical trials and permit review, as well as evaluation of manufacturing and quality control standards.”
■ Safety
The final check point explained that the safety-related abnormal cases reported were related to vaccine administration such as pain at the injection site, headache, fatigue, and muscle pain, and symptoms were mostly mild to moderate, and that they recovered within 2 to 3 days after vaccination.
Of the 43,783 subjects enrolled in the clinical trial, “significant abnormal cases” were reported in 0.4% (83 patients) in the vaccine group and 0.4% (96 patients) in the control group. Reaction’ is a total of 7 cases including Guillain-Barre syndrome, pericarditis, brachial neuromyositis, post-vaccination syndrome, hypersensitivity reaction, and 2 facial paralysis.
Based on these results, the final inspection committee judged that the overall safety of the vaccine was good.
■ Effectiveness
The final inspection committee said, “As a result of reviewing the clinical test data, it was judged that the preventive effect of the vaccine was acceptable.” However, it recommended that long-term immunogenicity be monitored.
As a result of clinical trials, after 14 days, 116 patients in the vaccine group and 348 patients in the control group were confirmed to have COVID-19, respectively, showing 66.9% preventive effect. After 28 days, 66 people in the vaccine group and 193 people in the control group showed a 66.1% preventive effect.[예방률(%)=100×(1-(백신접종군 중 확진자율)/(위약접종군 중 확진자율)]．
This preventive effect is the result of evaluating 39,321 people aged 18 years and older (19,630 people in the vaccine group and 19,691 people in the control group) who were 18 years of age or older who were negative for the Corona 19 virus in a multinational clinical trial conducted in the United States and the like.
■ Measures to secure safety after approval
The final inspection committee continued to observe safety such as tinnitus and cerebral sinus thrombosis through the’Risk Management Plan’ after approval, and continued to collect and evaluate abnormal cases arising from clinical trials and use after approval.
The Ministry of Food and Drug Safety added that even after the approval of the’Covid-19 vaccine Jansenju’, it will cooperate with the Korea Centers for Disease Control and Prevention to strengthen the surveillance system for abnormal cases after vaccination, and to do its best to ensure safe vaccination through thorough monitoring and prompt response.
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