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Conditions for the presentation of vaccines over 16 years of age, report of the final result of a clinical trial, etc. to demonstrate safety and efficacy.
The Ministry of Food and Drug Safety held a final inspection committee that included external experts on the 5th and presented a report on the final results of the Corona 19 ‘Cominati’ vaccine clinical trials, which Pfizer Korea Co., Ltd he requested permission. for an imported item in January. The permission of the article was decided on condition of that.
‘Cominati’ is the first vaccine licensed in Korea as an mRNA vaccine, and has received conditional approval or emergency use approval from 59 countries, including Europe (EMA), the United States, Japan, and the WHO.
The Ministry of Food and Pharmaceutical Safety added the ‘Corona 19 Treatment / Vaccine Safety and Efficacy Verification Advisory Group’ (hereinafter the verification advisory group) and the ‘Final Inspection Committee’ was additionally formed to prepare a triple consultation procedure.
The Ministry of Food and Drug Safety (KFDA) reviewed the vaccine’s efficacy and effectiveness, safety and effectiveness, and measures to ensure safety after approval based on submitted data, such as clinical trials of ‘Cominatiju ‘in the verification of February 22 (Monday). advisory group, February 25 (Thursday) We received advice from the Central Pharmacy Review Committee, and the meeting of the ‘Final Inspection Committee’ was held at 10 am on the 5th (Friday) at the Ministry of Food Safety and Medications to make a final decision on whether to approve the vaccine.
Today’s meeting, which is the final step in the Corona 19 vaccine approval process, was attended by three outside experts, including Chairman Yoo-hwan of the Central Pharmacy Review Committee, and five insiders, including the chief of the Food and Drug Administration. .
As a result of the exhaustive review of the KFDA examination results and the content of the two previous consultations, the Final Inspection Committee decided to approve the article on the condition of presenting the final report of the clinical trials for the ‘Province of Cominati ‘after approval. .
This is an in-depth review of the data required for approval review, including clinical trials, and comprehensive review of manufacturing and quality control standard (GMP) evaluations, recognizing safety and efficacy.
The Safety-Related Final Review Committee concluded that the majority of the reported safety-related adverse events were anticipated adverse events related to the administration of the vaccine and were generally good.
As a result of reviewing the results of the clinical trials presented in the same way as the results of the two previous consultations, the final review committee on effectiveness and performance determined that the preventive effect of the vaccine was sufficient.
The final review committee decided that it would be appropriate to grant permission to those over 16 years of age in the same way as the results of the two previous consultations regarding the suitability 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, and abnormal cases arising from clinical trials and post-approval use are continually 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 article 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 and it was announced that it will be implemented in accordance with the vaccination strategy and priorities set by the promotion team of the response to vaccination.
KFDA approval was based on non-clinical, clinical, and quality data submitted by Pfizer Pharmaceuticals Korea, and included in The New England Journal of Medicine (NEJM) in November 2020. Published phase 3 clinical data is also included. Based on the results of the study, both in subjects who did not have Corona 19 (the first primary endpoint) and those who did or did not have Corona 19 (the second secondary endpoint), ‘Cominatiju’ showed a preventive effect of 95 %. In both cases, the effect was measured 7 days after the completion of the second vaccination and the preventive effect was constant regardless of age, sex, race and ethnic composition.
Dong-wook Oh, President and CEO of Pfizer Korea, said: “The Comatinity permit is a historic moment for the end of the deadly coronavirus outbreak and contains Pfizer’s promise and dedication to provide a coronavirus vaccine to the humanity”. we are grateful for the efforts of regulatory authorities to carefully review and accelerate the corona 19 vaccine to protect against the infectious disease crisis. “
Sean Marett, Commercial Director and Managing Director of Sales and Marketing at Biontech, a joint developer from Comatin Province, 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 issue to resolve the Corona 19 pandemic ”.
‘Cominati’ is a vaccine developed by Pfizer based on Bioentech’s own 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 is copyrighted in the United States, Europe, the United Kingdom, Canada, and other countries.
Previously, 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 lots). Under this contract, Pfizer Pharmaceutical Korea is expected to supply the vaccine in 2021.
In addition, Pfizer and Bioentech signed a contract for the advance purchase of up to 40 million doses of vaccine with the COVAX Facility, an international vaccine supply organization in January). It has been provided, and since last February, vaccination has been done mainly by doctors. staff treating corona patients 19.
