MFDS Begins Approval Review for AstraZeneca COVID-19 Vaccine (Update)

"Thorough Verification of Safety and Effectiveness... Target Review Within 40 Days"

The COVID-19 vaccine and syringe placed in front of the AstraZeneca logo (Jenicha Reuters=Yonhap News)

[Asia Economy Reporter Kim Heung-soon] On the 4th, the Ministry of Food and Drug Safety announced that it has received an application for product approval of the novel coronavirus disease (COVID-19) vaccine 'AZD1222' from Korea AstraZeneca and has begun the review process.

The vaccine applied for approval this time is a 'viral vector vaccine' manufactured by inserting the gene of the COVID-19 virus surface antigen into a chimpanzee adenovirus template. The Janssen (Johnson & Johnson) vaccine was also developed using this method.

The expected vaccination target for the AstraZeneca vaccine is individuals aged 18 and over, and the expected dosage regimen is two doses: the first dose followed by a second dose 4 to 12 weeks later. Storage conditions are 2 to 8℃.

Korea AstraZeneca simultaneously applied for 'manufacturing and marketing approval' for products outsourced to the domestic pharmaceutical company SK Bioscience and 'import approval' for products produced overseas, including Italy.

The Ministry of Food and Drug Safety stated that, including this approval application, it aims to shorten the existing processing period (over 180 days) for rapid approval and review of COVID-19 vaccines and therapeutics to within 40 days.

This content was produced with the assistance of AI translation services.