[서울신문] Pfizer’s vaccine was first consulted by the Ministry of Food and Drug Safety on the 22nd, concluded whether approval was granted in the first week of March

AFP Yonhap News” style=”padding:0px;margin:0px”>Pfizer Biontech's COVID-19 vaccine image.  AFP Yonhap News

Click to view the original.

▲ Image of Pfizer Biontech’s Corona 19 vaccine.
AFP Yonhap News

The Ministry of Food and Drug Safety will receive the first advice from an external expert verification advisory group on the safety and effectiveness of Pfizer’s vaccine on the 22nd.

The Ministry of Food and Drug Safety announced on the 19th that it will hold a meeting of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ on the 22nd and disclose the results of the consultation on the 23rd. Until final product approval, two more procedures, including the Central Pharmacy Review Committee and the Final Inspection Committee, have to be passed. The Ministry of Food and Drug Safety is reviewing the non-clinical, clinical, and quality data submitted at the time of application for approval, and plans to complete the product approval within the first week of March.

This vaccine is a ribonucleic acid (mRNA) vaccine developed jointly by Pfizer of the United States and Bioentech of Germany. The preventive effect shown in clinical trials was about 95%, the highest among the five corona 19 vaccines that were decided to be imported into Korea.

Separately, the initial volume of the Pfizer vaccine, which was brought in from the end of this month to the beginning of next month through the Multinational Vaccine Alliance, was approved for special import on the 3rd. Special import is the import of drugs that are not approved in Korea when the head of a related agency, such as the Director of the Korea Centers for Disease Control and Prevention, requests a special case to respond to the public health crisis. The initial volume of 585,000 people will be vaccinated first by medical staff working at hospitals dedicated to infectious diseases.

Reporter Lee Hyun-jung [email protected]

Source