Pfizer’s novel coronavirus infection (Corona 19) vaccine’Cominati’ has received a domestic product license.
The Ministry of Food and Drug Safety held a final inspection committee including external experts and conducted a clinical trial on the Corona 19 vaccine’Cominatiju’, which Pfizer Korea Co., Ltd. applied for permission for an imported item on January 25, 2021. It was announced on the 5th that it had decided to grant permission as a condition to submitting the final report and the like.
In terms of safety, the final review committee judged that the reported adverse events were mostly predicted adverse events related to vaccine administration, and were generally good.
According to the results of multinational clinical trials conducted in the United States and other countries, 8 out of 18,198 people in the vaccine group and 8,325 people in the control group were confirmed to have COVID-19, showing a preventive effect of about 95%.
The final review committee decided that it would be appropriate to give permission to those over 16 years of age in the same way as the results of the previous two consultations regarding the appropriateness of efficacy and effectiveness for those over 16 years of age.
In addition, the overall safety security plan is appropriate, and it has been decided to continuously monitor the safety of anaphylaxis and lymphadenopathy through the’risk management plan’ after approval, and to continuously collect and evaluate abnormal cases arising from clinical trials and use after approval. .
As Pfizer’s Corona 19 vaccine is approved after 39 days of application, the timing and targets of Pfizer’s vaccine will be discussed and decided.
The Ministry of Food and Drug Safety said, “Even after the product is approved, we will do our best to ensure that the public can receive the vaccination with confidence through strict monitoring and prompt response, and strengthening the surveillance system for abnormal cases after vaccination in cooperation with the Korea Disease Control and Prevention Agency.”
[ 경기신문 = 오재우 기자 ]
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