On the morning of the 25th,’Pfizer’ vaccination mock training was held at the vaccination center at Keimyung University Daegu Dongsan Hospital in Jung-gu, Daegu, with vaccination officers and hospital officials in each district of Daegu. Medical staff are vaccinating training participants. News 1
An expert advisory opinion came out that Pfizer’s new coronavirus infection (Corona 19) vaccine’Cominatiju’ can be licensed for use at the age of 16 or older in Korea.
The Ministry of Food and Drug Safety announced on the 26th that this conclusion was reached at a meeting of the Central Pharmacist Review Committee (Central Pharmacopoeia), the second expert advisory procedure in the phase of Pfizer vaccine use approval.
The Ministry of Food and Drug Safety previously held a meeting at the headquarters of the Food and Drug Administration in Osong, Chungbuk, at 2 pm on the 25th. The Central Pharmacopoeia is a legal advisory body for approval review by the Ministry of Food and Drug Safety.
The Central Pharmacist said, “As a result of discussing whether or not the safety and effectiveness of this drug is recognized through the data submitted by Pfizer for the application for product permission in the state of Cominati, the need for the purpose of preventing Corona 19 in Korea was recognized, and the safety and effectiveness of the Corona 19 vaccine. When synthesizing the results of the verification advisory group’s consultation, it was concluded that product approval is possible.”
He added, “Based on the preventive effect confirmed in the results of clinical trials including 16 years of age or older, it is reasonable to approve the approval for subjects 16 years of age or older in the same way as the efficacy and effect of the application.” However, in consideration of the fact that the immune response of adolescents aged 16 and older is not different from that of adults, clinical trial data of adults are available, the efficacy and safety in adolescents aged 16-17 are extrapolated from the data of adults in Korea and the United States. It was recommended to write in the permission information that it was (statistically expanded and applied values outside the range as available data).
Corona 19 Pfizer vaccine distribution and transportation process. Graphic = Kim Eun-kyo [email protected]
Regarding safety, “Abnormal cases that occurred in clinical trials are acceptable. However, for those with a history of hypersensitivity, including anaphylaxis (a sudden systemic reaction caused by an antigen-antibody immune reaction), close monitoring after administration was concluded. It is recommended that the reported abnormal cases be clearly reflected in the permission matters.
Pfizer’s vaccine is about 95% effective in preventing COVID-19. The Central Pharmacopoeia concluded that this effect was confirmed in the data submitted on the preventive effect of the vaccine, and that the preventive effect for approval was sufficient.
Reporter Chun Gyeong-hwan = Yoo-hwan, chairman of the Central Pharmacy Review Committee, announced the results of the’Cominatiju’ vaccine verification meeting (Cheongju = Yonhap News). The results of the Central Pharmacy Review Committee meeting, which verified the stability and effectiveness of’Natiju’, are being announced. 2021.2.26 [email protected] (End) 〈Copyright (c) Yonhap News, Unauthorized Reprint-Redistribution Prohibited〉
In addition, in order to ensure safety in the administration process after approval, the safety of anaphylaxis and lymphadenopathy (symptoms caused by lymph node enlargement) are continuously observed through the’Risk Management Plan’ after approval, and information is continuously collected and evaluated for abnormal cases that appear during clinical trials. He said it should.
Lee Dong-hee, head of the Food and Drug Safety Assessment Director of the Ministry of Food and Drug Safety, said, “The experts’ opinions, efficacy, effects, usage, dose, and recommendations obtained from the consultation with the COVID-19 vaccine safety and effectiveness verification advisory group and the Central Pharmacopoeia are summarized, After reviewing the additional materials required for the inspection, a final inspection committee will be held to make a final decision on whether to grant permission.”
Meanwhile, the US Food and Drug Administration (FDA) approved on the 25th (local time) that the Pfizer vaccine could be stably stored for 2 weeks at minus 25 to minus 15 degrees Celsius rather than cryogenic freezing. This is the result of Pfizer’s review and submission of additional data on FDA storage temperatures. In-sook Park, head of the Bio-Pharmaceutical Review Manager of the Ministry of Food and Drug Safety, said, “We are currently reviewing the Pfizer vaccine, and the storage temperature (Pfizer) applied for domestic approval is -90~60℃. We have not yet submitted data on general freezing storage. No. I will review it when it is submitted later.”
Reporter Esther [email protected]
