[엠디데일리] On the 26th, Chairman Yoo-hwan of the Central Pharmacy Review Committee said, “When synthesizing the opinions of the Central Pharmacy Review Committee, we gathered opinions that Korea Pfizer Pharmaceutical Co., Ltd. can approve the corona 19 vaccine coma.”
The Ministry of Food and Drug Safety announced the same contents as a result of holding a meeting of the Central Pharmacy Review Committee on the 25th at the headquarters of the Ministry of Food and Drug Safety in Osong, Chungbuk, with 19 people including external vaccine experts and 8 members of the Ministry of Food and Drug Safety.
The Central Pharmacy Review Committee discussed with the members whether or not the safety and effectiveness of this drug was recognized through the data submitted by Pfizer Pharmaceuticals in Korea for an application for permission for an item in Cominati.
As a result of the discussion, the necessity of the domestic Corona 19 prevention purpose of the applied item was acknowledged, and the product approval was advised when synthesizing the consultation results of the safety and effectiveness verification advisory group for the Corona 19 vaccine.
In this regard, Chairman Oh explained, “Based on the preventive effect identified in the clinical trial results, including the adequacy of the application effect and the adequacy of the application, it was the opinion that it would be appropriate to grant permission to target persons 16 years of age or older in the same manner as the efficacy and effect of the application.” .
In addition, he said, “In Korea, it is recommended to state that the efficacy and safety in adolescents aged 16 to 17, as in the United States, can be approved by extrapolating from adult data.”
Regarding the safety and acceptability, it was reported that “the safety profile such as abnormal cases that occurred in clinical trials is an acceptable level, but for people with a history of hypersensitivity, including anaphylaxis, close monitoring is required after administration.” It was recommended that the cases be clearly reflected in permission matters.
Chairman Oh said, “As the overall views on the effectiveness of the vaccine were confirmed in the data submitted on the preventive effect of the vaccine, we judged that the preventive effect for approval was sufficient.”
He added, “As for the way to secure safety after permission, it was appropriate to continuously monitor the safety such as anaphylaxis and lymphadenopathy through a risk management plan over a long period of time, and to continuously collect and evaluate information for abnormal cases that appear during clinical trials. “He added.
According to the announcement on the day, the Ministry of Food and Drug Safety will hold a final inspection committee to decide whether to approve or not after reviewing additional submitted materials necessary for final inspection, such as quality data of’Cominatiju’.
In addition, he emphasized that it will collect various experts’ opinions in the process of reviewing the approval of COVID-19 treatments and vaccines to secure objectivity and transparency, and to proceed so that thorough approval and review can be accomplished.
Reporter Lee Young-bok 48yblee
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