Corona 19 vaccine and syringe placed in front of Pfizer’s logo. yunhap news
Pfizer’s new coronavirus infection (Corona 19) vaccine, which is expected to start inoculation next month, will be the first external verification team on the 22nd. Pfizer vaccine, like AstraZeneca vaccine, receives final product approval after consulting three times.
The Ministry of Food and Drug Safety announced on the 19th that it will hold a meeting on the 22nd of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ for Pfizer’s Corona 19 vaccine’Cominatiju’. The results will be released on the 23rd.
The verification advisory group is a procedure for the Ministry of Food and Drug Safety to seek advisory opinions on clinical, non-clinical, quality, and other fields from various experts before the Central Pharmacy Review Committee (Central Pharmacy Review Committee), which is the legal advisory body of the Ministry of Food and Drug Safety. Previously, there was only the Central Pharmaceutical Affairs Commission, but in order to thoroughly verify the Corona 19 vaccine and treatment drug developed in a short period of time, new procedures such as a verification advisory group and a final inspection committee were created before and after the Central Pharmacy Commission. External experts, such as infectious medicine specialists, participate in the three consultations, and the Ministry of Food and Drug Safety decides whether to finalize the approval based on the results of this consultation. Previously, AstraZeneca vaccine and Celltrion treatment (Rekirona) received product approval through the same procedure.
Cominati is an mRNA vaccine jointly developed by Pfizer, a US pharmaceutical company, and Bioentech, a German pharmaceutical company. On the 25th of last month, it applied for an item permission from the Ministry of Food and Drug Safety and is currently undergoing examination. The mRNA vaccine induces an immune response by injecting an antigen gene into the human body in the form of RNA to produce an antigen protein in the body.
Jinjoo Kim reporter [email protected]
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