[엠디데일리] On the 2nd, the Korea Centers for Disease Control and Prevention announced on the 2nd that it will apply for a special import to the Ministry of Food and Drug Safety for 117,000 doses of Pfizer vaccine, which will be supplied through the Covax Facility after mid-February to prevent Corona 19.
This is in accordance with Article 85-2 of the Pharmaceutical Affairs Act (Special Cases concerning Preventive Treatment Drugs in the case of national emergencies, etc.) reflecting the results of expert advisory meetings jointly held by the Ministry of Food and Drug Safety and the Korea Disease Administration.
The advisory meeting consisted of 11 members, including vaccine and clinical experts, and experts recommended by the medical association.
In accordance with Article 85-2, Paragraph 1 of the Pharmaceutical Affairs Act, in the case of a national emergency such as an infectious disease pandemic, it is possible to manufacture and import preventive and therapeutic drugs without domestic product permission at the request of the head of the relevant department.
At the advisory meeting, experts said that the COVAX Pfizer vaccine was ▲ approved for use by major countries such as the World Health Organization (WHO) and the US Food and Drug Administration (FDA) ▲ The Korean Food and Drug Administration also participated in the WHO safety, efficacy, and quality evaluation as a cooperative review. Considering the points, etc., they agreed to the need for special income.
On the same day, the Agency for Disease Control and Prevention applied for a special import of COVAX Pfizer vaccine to the KFDA, and as soon as the KFDA’s special approval process 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.
In addition, preparations for vaccination will proceed without any problems so that the vaccine can be vaccinated immediately upon arrival in Korea.
Reporter Lee Young-bok 48yblee
<저작권자 © 엠디저널, 무단 전재 및 재배포 금지>