'Omicron Included'... MFDS Begins Approval Review for Pfizer's Next-Generation Vaccine

Pfizer COVID-19 Vaccine [Image Source=Reuters Yonhap News]

[Asia Economy Reporter Chunhee Lee] The Ministry of Food and Drug Safety announced on the 29th that it has begun reviewing the import approval application for the COVID-19 bivalent vaccine ‘Comirnaty 2주 0.1㎎/㎖’ submitted by Pfizer Korea.

This vaccine is a bivalent vaccine using messenger RNA (mRNA) technology that expresses antigens for both the original COVID-19 virus and the Omicron BA.1 variant. The indicated use is 'prevention of COVID-19 caused by the SARS-CoV-2 virus in individuals aged 12 and older,' developed for use as an additional dose following primary vaccination.

The Ministry of Food and Drug Safety will promptly and thoroughly review the clinical, non-clinical, quality, and GMP data submitted with the application, and consult vaccine experts including infectious disease specialists regarding the safety and efficacy of the vaccine before deciding on approval. To expedite the review process, a preliminary review application submitted by Pfizer Korea on the 5th is currently underway.

The Ministry is also reviewing the bivalent vaccine ‘Moderna Spikevax 2주,’ developed by Moderna using the same method of expressing antigens for the original COVID-19 virus and the BA.1 variant. Moderna Korea applied for a preliminary review on the 20th of last month and submitted an import approval application on the 29th.

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