As the new coronavirus infectious disease (Corona 19) 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 applied for 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 outside experts including Chairman Yoo-hwan of the Central Pharmaceutical Affairs Review Committee and five insiders, including the head of the Food and Drug Administration, attended the meeting. .
The final inspection committee comprehensively reviews the results of the KFDA’s review and the contents of the two previous consultations of the’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ and the’Central Pharmacy Review Committee’, and conditional approval for’Cominati’. Decided.
The KFDA approval was based on data on non-clinical, clinical, and quality 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. have. In this study, two doses of Comeati showed consistent 95% prophylactic effect regardless of age, sex, race, and ethnic composition.
According to the approval of the Ministry of Food and Drug Safety, the domestic vaccination of’Cominati’ will be implemented according to the vaccination strategy and priorities established by the Korea Centers for Disease Control and Prevention’s Corona 19 Vaccination Response Promotion Team.
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 additionally signed in February this year, for a total of 13 million people. It has signed a supply contract of (26 million doses). Under this contract, Pfizer Pharmaceutical Korea is expected to supply the vaccine within 2021.
Separately, Pfizer and Bioentech signed a vaccine pre-purchase agreement with COVAX Facility, an international vaccine supply organization, with a maximum dose of 40 million doses in January. ), and vaccination has been conducted mainly by domestic medical workers since last February.
Dong-wook Oh, President and CEO of Pfizer Korea, said, “Cominati’s permission is a historic moment for ending the deadly coronavirus outbreak, and it contains Pfizer’s promise and dedication to provide a vaccine against the coronavirus to humanity.” “We are grateful for the efforts of the regulators to carefully review the Corona 19 vaccine and proceed quickly to protect it from the crisis,” he said.
Sean Marett, Chief Business Officer and General Manager of Sales and Marketing at BioEntech, a joint developer in Comati, said, “We are very pleased that our mRNA vaccine has been licensed in Korea.” It is an important matter in resolving the Corona 19 pandemic.”