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As the new coronavirus (Corona 19) infectious disease vaccine ‘Cominati’ jointly developed by Pfizer and BioEntech received conditional approval from the Ministry of Food and Drug Safety, a total of 13 million vaccines will be supplied to Korea in sequence.
On the 5th, the Ministry of Food and Drug Safety approved the COVID-19 vaccine ‘Cominati (ingredient name Land Nameran)’, which Pfizer Korea requested permission as an imported item, as a condition of submitting a final report on the clinical trial. results.
On the morning of the same day, the Ministry of Food and Drug Safety held a final inspection committee and finally discussed whether to approve the product for ‘Cominati’, and three external experts, including Chairman Yoo-hwan of the Central Review Committee of Pharmaceutical Affairs and The meeting was attended by five experts, including the head of the Food and Drug Administration.
The final inspection committee thoroughly reviews the results of the KFDA review and the content of the two prior consultations of the ‘Crown 19 Treatment / Vaccine Safety and Efficacy Verification Advisory Group’ and the ‘Crown Central Committee on Review of Pharmacies ‘, and the conditional approval of’ Cominati Decidido.
The KFDA approval was based on non-clinical, clinical, and quality data submitted by Pfizer Pharmaceuticals Korea, including data on phase 3 clinical trials published in the New England Journal of Medicine (NEJM) in November last year. In this study, two doses of Comeati showed a constant 95% prophylactic effect regardless of age, sex, race, and ethnic composition.
In accordance with the approval of the Ministry of Food and Drug Safety, the domestic vaccination of ‘Cominati’ will be implemented in accordance with the vaccination strategy and priorities established by the Corona 19 Vaccination Response Team of the Centers for Control and Korea Disease Prevention.
Pfizer Pharmaceutical Korea signed a supply contract with the Korean government for 10 million people (20 million doses) for ‘Cominati’ in December last year, and 3 million people (6 million doses) were also signed in February this year, for a total of 13 million people has signed a supply contract for (26 million doses). Under this contract, Pfizer Pharmaceutical Korea is expected to supply the vaccine in 2021.
Separately, Pfizer and Bioentech signed a vaccine advance purchase agreement with COVAX Facility, an international vaccine supply organization, with a maximum dose of 40 million doses in January), and vaccination has been performed primarily by domestic medical workers. since last February.
Dong-wook Oh, President and CEO of Pfizer Korea, said: “The Cominati permit is a historic moment to end the deadly coronavirus outbreak and contains Pfizer’s promise and dedication to provide a coronavirus vaccine to the humanity”. for the efforts of regulators to carefully review the Corona 19 vaccine and to proceed quickly to protect it from the crisis, “he said.
Sean Marett, Commercial Director and General Manager of Sales and Marketing for BioEntech, a joint developer at Comati, said: “We are very pleased that our mRNA vaccine has been licensed in Korea.” It is an important issue to solve the Corona 19. pandemic problem. “
