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[의학신문·일간보사=안치영 기자] As early as the middle of this month, 117,000 doses of Pfizer vaccine will be introduced into Korea through special import.
The Korea Centers for Disease Control and Prevention (CEO Jeong Eun-kyung) reflected the results of an expert advisory meeting (hereinafter referred to as’advisory meeting’) held in conjunction with the Ministry of Food and Drug Safety (hereinafter referred to as’Food and Drug Administration’) on the 2nd. It has announced that it will apply for special importation to the Ministry of Food and Drug Safety for 117,000 doses of the Corona 19 Pfizer vaccine, which will be supplied through.
In accordance with Article 85-2 of the Pharmaceutical Affairs Act, in the case of a national emergency such as a pandemic of infectious diseases, the head of the relevant ministry may request the manufacture and import of preventive and therapeutic drugs without domestic product license.
At the advisory meeting, experts agreed on the need for special imports, taking into account the fact that the COVAX Pfizer vaccine was approved for use by major countries such as WHO and FDA, and that the Korean Food and Drug Administration also participated in the WHO safety, efficacy, and quality evaluation through a cooperative review.
Currently, Pfizer’s vaccine has been approved for emergency use (EUL) by WHO, and is known to have received emergency use approval (EUA) from the United States (FDA) and conditional approval from Europe (EMA).
On the 2nd, the Korean Agency for Disease Control and Prevention applied for a special import of COVAX Pfizer vaccine to the Ministry of Food and Drug Safety, and as soon as the special approval procedure of the Ministry of Food and Drug Safety is completed, a supply-related contract with Pfizer and a delivery contract with UNICEF, It plans to expedite relevant administrative procedures such as customs clearance.
The Agency for Disease Control and Prevention said, “We will continue to prepare for vaccination so that the Pfizer vaccine can be vaccinated as soon as it arrives in Korea.”
Reporter Chi-Young Ahn [email protected]
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