MFDS Begins Approval Review for Moderna COVID-19 Vaccine

mRNA Vaccine Developed on the Same Platform as Pfizer Vaccine

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The domestic approval process for Moderna's COVID-19 vaccine from the United States has begun. If the Moderna vaccine is approved, it will become the fourth COVID-19 vaccine in the country following AstraZeneca, Pfizer, and Janssen.

On the 12th, the Ministry of Food and Drug Safety announced that Green Cross had applied for import approval of the COVID-19 vaccine developed by Moderna in the United States. The Moderna vaccine is one of the vaccines announced in the government's procurement plan and was developed to be administered twice at 28-day intervals. It is an 'mRNA vaccine' that injects the antigen gene of the COVID-19 virus in the form of messenger RNA (mRNA), generating antigen proteins in the body to induce an immune response. It uses the same platform as Pfizer's Comirnaty, which was previously approved domestically.

The Ministry of Food and Drug Safety plans to carefully review the submitted quality, non-clinical, clinical, and GMP data and decide on approval after an advisory process. To evaluate the safety and efficacy of the COVID-19 vaccine, the Ministry will conduct a three-tier advisory process involving the COVID-19 Vaccine Safety and Efficacy Verification Advisory Group, the Central Pharmaceutical Review Committee, and the Final Inspection Committee.

Moderna's COVID-19 vaccine has received emergency use authorization in the United States, the United Kingdom, and has been conditionally approved in the European Union (EU), Canada, and Switzerland, requiring additional data submission after approval.

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