MFDS Begins Approval Review for Pfizer COVID-19 Vaccine

Phase 3 Clinical Trials Currently Underway in Six Countries Including the United States and Germany

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 25th that Korea Pfizer Pharmaceutical has applied for marketing authorization for the novel coronavirus disease (COVID-19) vaccine 'Comirnaty' and that the approval review has commenced.

The product for which approval was applied is an mRNA vaccine jointly developed by Pfizer in the United States and BioNTech in Germany. It is a vaccine that induces an immune response by injecting the antigen gene of the COVID-19 virus in the form of mRNA, which then produces antigen proteins within the body. Although the manufacturing period is short, allowing for mass production in a short time, it requires an ultra-low temperature cold chain system due to its poor stability. Another vaccine developed using the mRNA vaccine platform is Moderna's vaccine from the United States.

The expected target population for the Pfizer COVID-19 vaccine is individuals aged 16 and older. After the first dose, an additional dose is administered three weeks later, and the storage condition is between -60 to -90℃ for six months.

Pfizer is currently conducting Phase 3 clinical trials in six countries including the United States, Germany, and Brazil. The trials have been conducted on individuals aged 12 and older, including those aged 65 and above. Currently, 28 regulatory agencies worldwide have granted emergency use authorization or conditional approval. Notably, the European Union confirmed a 95% preventive efficacy based on clinical trial results involving about 40,000 people and granted conditional approval on December 21 of last year.