[현장생중계]Pfizer Vaccine Announcement of Approval (March 5)

[김강립 / 식품의약품안전처 처장]

The Corona 19 Vaccine Authorization Review Team, composed of expert reviewers, intensively reviewed the materials necessary for authorization, such as non-clinical, clinical, and quality.

In the non-clinical trial review, efficacy tests to determine the effectiveness of vaccines in animals, pharmacokinetic tests on absorption, distribution, metabolism, and excretion of drugs, and toxicity tests to confirm toxicity due to drugs were evaluated.

In the clinical trial review, a total of two data were submitted, including one clinical trial conducted in Germany and one multinational clinical trial conducted in six countries including the United States. The immunogenicity was evaluated through clinical trials conducted in Germany and the United States.

Quality audit is a document on the implementation status of manufacturing quality management standards of overseas manufacturing plants in order to evaluate whether facilities and management systems that can consistently produce product quality are in place along with data on manufacturing methods, standards, test methods, etc. We conducted an evaluation.

The Ministry of Food and Drug Safety went through a triple consultation procedure of the central pharmacist review matters of the verification advisory group and the final inspection committee in order to increase the expertise and objectivity of the approval review process for the Corona 19 vaccine.

Meanwhile, on February 22, we received advice from the verification advisory group and on February 25 from the Central Pharmacy Review Committee. At 010 am today, a final inspection committee was held to decide whether or not to approve items in the state.

In today’s meeting, the final stage of the COVID-19 vaccine approval process, three external experts, including Chairman Yu-hwan of the Central Pharmacy Review Committee, and five people from the Food and Drug Administration attended.

The final inspection committee comprehensively reviewed the review results of the Ministry of Food and Drug Safety, and the contents of the previous two consultations, and recognized the safety and effectiveness of Cominati Province, and decided to approve the item under the condition of submitting the final report of clinical trials after approval .

First, let me tell you the results of the safety review. The final review committee judged that most of the adverse events reported in relation to safety were predicted adverse events related to vaccine administration and were generally good.

In general, the most common abnormal cases were injection site pain and fever, and most of the symptoms were mild to moderate and recovered within a few days after vaccination.

After vaccination, a drug-related hypersensitivity reaction occurred in one case of hives, and drug-related anaphylactic reactions were not reported in clinical trials.

[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]