![[약업신문]Pfizer Corona 19 vaccine’Cominati’ final product approval approval](http://www.yakup.com/images/common/yakup.jpg "[약업신문]Pfizer Corona 19 vaccine’Cominati’ final product approval approval")
Conditions for submission of vaccinations over 16 years of age, clinical trial final result report, etc. to prove safety and effectiveness
The Ministry of Food and Drug Safety held a final inspection committee including external experts on the 5th, and submitted a report on the final results of clinical trials for the Corona 19 vaccine’Cominati’, which Pfizer Korea Co., Ltd. applied for permission for an imported item in January. The item permission was decided on the condition of that.
‘Cominati’ is the first vaccine to be licensed in Korea as an mRNA vaccine, and it has received conditional approval or emergency use approval from 59 countries including Europe (EMA), the United States, and Japan, and WHO.
The Ministry of Food and Drug Safety added the’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as The verification advisory group) and the’Final Inspection Committee’ were additionally formed to prepare a triple consultation procedure.
The Ministry of Food and Drug Safety (KFDA) reviewed the efficacy and effectiveness of the vaccine, safety and effectiveness, and measures to secure safety after approval based on the data submitted such as clinical trials of’Cominatiju’ on February 22 (Mon) verification advisory group, February 25 (Thursday) We received advice from the Central Pharmacy Review Committee, and the’Final Inspection Committee’ meeting was held at 10 am on the 5th (Fri) at the Ministry of Food and Drug Safety to make a final decision on whether or not to approve the vaccine.
At today’s meeting, which is the final step in the approval process for the Corona 19 vaccine, three outside experts, including Chairman Yoo-hwan of the Central Pharmacy Review Committee, and five insiders, including the head of the Food and Drug Administration, attended.
As a result of comprehensively reviewing the results of the KFDA examination and the contents of the previous two consultations, the Final Inspection Committee decided to approve the item under the condition of submitting the final report of clinical trials for’Cominati Province’ after approval. did.
This is an in-depth review of the data necessary for approval review, including clinical trials, and comprehensively reviewing manufacturing and quality control standards (GMP) evaluations, acknowledging safety and effectiveness.
Safety-related Final Review Committee concluded that most of the reported adverse events related to safety were predicted adverse events related to vaccine administration and were generally good.
As a result of reviewing the results of clinical trials submitted in the same manner as the results of the previous two consultations, the final review committee on effectiveness and performance determined that the vaccine’s preventive effect was sufficient.
The final review committee decided that it would be appropriate to give permission to those over 16 years of age in the same way as the results of the previous two consultations regarding the appropriateness of efficacy and effectiveness for those over 16 years of age.
The final inspection committee is appropriate to ensure the overall safety, and after approval, through the’Risk Management Plan’, the safety of anaphylaxis and lymphadenopathy is continuously observed, and abnormal cases arising from clinical trials and use after approval are continuously collected and evaluated. Decided to do.
On the other hand, Pfizer Korea is today (5th), as the Sascoronavirus-2 mRNA vaccine (Tojina Meran, code name: BNT162b2)’Cominati’ has obtained an item license from the Ministry of Food and Drug Safety, so the inoculation in Korea is limited to Corona 19 by the Korea Centers for Disease Control and Prevention. It was announced that it will be implemented according to the vaccination strategy and priorities established by the vaccination response promotion team.
The approval of the KFDA was based on data on non-clinical, clinical, and quality submitted by Pfizer Pharmaceuticals Korea, and included in The New England Journal of Medicine (NEJM) in November 2020. The published phase 3 clinical data is also included. According to the study results, in both subjects who did not develop Corona 19 (the first primary endpoint) and those who have or did not have Corona 19 (the second secondary endpoint),’Cominatiju’ showed a 95% preventive effect. In both cases, the effect was measured 7 days after the completion of the second vaccination, and the preventive effect was consistent regardless of age, sex, race, and ethnic composition.
Dong-wook Oh, President and CEO of Pfizer Korea, said, “The permission of Comatinity is a historic moment for the end of the deadly coronavirus outbreak, and contains Pfizer’s promise and dedication to provide a vaccine against the coronavirus to humanity.” We are grateful for the efforts of the regulatory authorities to carefully review and expedite the corona 19 vaccine to protect against the infectious disease crisis.”
Sean Marett, Chief Business Officer and General Manager of Sales and Marketing at Biontech, a joint developer of the province of Comatin, said, “We are very pleased that our mRNA vaccine has been licensed in Korea, and the number of countries that approve the use of Comatin is steadily increasing. It is an important matter in resolving the Corona 19 pandemic.”
‘Cominati’ is a vaccine developed by Pfizer based on Bioentech’s self-developed mRNA technology, and has obtained conditional approval, emergency use approval, or temporary approval in more than 50 countries. Pfizer Pharmaceuticals Korea is eligible for marketing licenses in Korea, and Bioentech has copyrights in the United States, Europe, the United Kingdom, Canada and other countries.
Earlier, the government and Pfizer Pharmaceutical Korea signed a supply contract for 10 million people (20 million times) in Coma in December 2020, and an additional contract for 3 million people (6 million times) in February 2021, for a total of 13 million. It has signed a supply contract for justification (26 million batches). Under this contract, Pfizer Pharmaceutical Korea is expected to supply the vaccine within 2021.
In addition, Pfizer and Bioentech signed a contract for pre-purchase of up to 40 million doses of vaccine with COVAX Facility, an international vaccine supply organization in January. ) Has been supplied, and since last February, vaccination has been conducted mainly by medical staff who treat corona19 patients.