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The Ministry of Food and Drug Safety announced on the 7th that it has decided to approve the product for the new coronavirus infection (Corona 19) vaccine’Covid-19 vaccine Janssenju’ developed by Janssen on the condition of submitting the final results of clinical trials.
‘Covid-19 Vaccine Janssen’ is a virus vector-based vaccine developed by Janssen in the United States.The corona 19 virus surface antigen gene is recombined and injected into human adenovirus to synthesize an antigen protein, and this protein is a neutralizing antibody. By inducing the production of COVID-19, it neutralizes and removes the virus when it invades the human body. Unlike other vaccines that require a total of 2 vaccinations, it is characterized by a single vaccination of 0.5 ml for the age group over 18 years of age. Storage conditions are also relatively simple, at -25 to 15 degrees Celsius below zero, so 35 countries including Europe (EMA), the United States, and Switzerland and WHO obtained conditional permission or emergency use approval.
The Ministry of Food and Drug Safety, through the’Central Pharmacy Review Committee’ and the’Corona 19 Treatment/Vaccine Safety/Effective Verification Advisory Group’ (hereinafter referred to as the Verification Advisory Group) among the triple advisory procedures established to increase the expertise and objectivity of the Corona 19 vaccine license review process. Already acknowledged the efficacy of the Janssen vaccine. At the final stage of the triple procedure held on the morning of the 7th, the final inspection committee said, “In-depth review of the data required for approval review including clinical trials, and evaluation of manufacturing and quality control standards were comprehensively reviewed to recognize safety and effectiveness. It was decided to approve the product under the condition of submitting the final test result report after permission.”
According to the results of review by the final inspection committee based on the clinical data submitted in the same manner as the results of the previous two consultations, the preventive effect was 66.9%, and it was judged that the preventive effect of the vaccine was acceptable. However, the final inspection committee decided to continuously monitor safety such as tinnitus and cerebral sinus thrombosis through the’Risk Management Plan’ after approval, and to continuously collect and evaluate abnormal cases arising from clinical trials and use after approval. The Ministry of Food and Drug Safety has thoroughly verified the safety and effectiveness of Janssen Korea’s’Covid-19 vaccine Jansenju’ through a triple consultation procedure. Plan.
/ Reporter Ji-hye Seo [email protected]
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