Prior to the Pfizer’s Corona 19 Vaccine Central Pharmacist Review Committee held at the Ministry of Food and Drug Safety in Osong-eup, Cheongju-si, Chungbuk on the 25th, experts and other review members are preparing a meeting. News 1
The Central Pharmacist Review Committee (Central Pharmacopoeia), the legal advisory body of the Ministry of Food and Drug Safety, recommended product permission for Pfizer’s Corona 19 vaccine’Cominatiju’. The recommended age for permission is 16 years of age or older, and it was determined that high school students can vaccinate.
Lee Dong-hee, head of the Food and Drug Administration of the Ministry of Food and Drug Safety, said in a briefing on the consultation results of the Pfizer’s Corona 19 Vaccine Central Pharmacy Review Committee on the 26th. We advised that we could give permission.”
Director Lee added, “Based on the preventive effect confirmed in the clinical results, including those over 16 years old, there was an opinion that it would be appropriate to grant permission to subjects over the age of 16 in the same way as the efficacy and effect of the application.”
The explanation is that it considered the availability of adult clinical trial data because the immune response of adolescents over 16 years old is not different from that of adults.
The safety was also judged at an acceptable level. However, opinions gathered that people with a history of hypersensitivity including anaphylaxis (past medical history) need close observation after administration.
Director Lee explained, “Through the risk management plan after approval, it is appropriate to continuously observe the safety of anaphylaxis and lymphadenopathy, and to continuously collect and evaluate information on abnormal cases that appeared during clinical trials.”
The Ministry of Food and Drug Safety is operating a’triple’ advisory procedure for external experts leading to the verification advisory group, the central medicine trial, and the final inspection committee for objective approval of the COVID-19 vaccine and treatment.
Earlier at the verification advisory group meeting, experts also saw that the Pfizer vaccine has a sufficient preventive effect in all clinical trial subjects, including the elderly over the age of 65. They also thought that this vaccine could be administered to 16-17 years old.
Pfizer Vaccine only leaves the final review committee procedure. The final inspection committee decides whether to finalize approval based on the opinions of experts from the verification advisory group and the Central Pharmacopoeia, and the results of clinical trials. The Ministry of Food and Drug Safety predicts that approval will be issued in the first week of next week as early as possible.
This procedure is in accordance with Pfizer Korea’s application for an item license from the State of Comati on the 25th of last month, and is separate from the Pfizer vaccine of COVAX facility, an international vaccine joint purchase project that will be vaccinated from the 27th of this month. The COVAX-Pfizer Corona 19 vaccine went through a separate procedure: approval for special importation.
Yu Hwan-gu reporter [email protected]
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