MFDS Initiates Preliminary Review of Pfizer COVID-19 Vaccine

Advance Review Application Also Submitted for AstraZeneca Vaccine

Image source=London AFP Yonhap News Agency

[Asia Economy Reporter Kim Heung-soon] The Ministry of Food and Drug Safety (MFDS) has begun a preliminary review of Pfizer Pharmaceutical's novel coronavirus disease (COVID-19) vaccine.

On the 18th, the MFDS announced that Pfizer applied for a preliminary review of non-clinical and clinical (phases 1, 2, and 3) data before submitting the COVID-19 vaccine approval application. On the same day, AstraZeneca also applied for an additional preliminary review of quality data before applying for vaccine approval. This follows their previous preliminary review application for non-clinical data on October 6, with additional data submitted this time.

Accordingly, the MFDS plans to thoroughly examine the data from Pfizer and AstraZeneca. Currently, the MFDS operates two 'dedicated approval review teams' for expedited review in preparation for domestic approval applications of COVID-19 vaccines. The viral vector vaccine team reviews vaccines from AstraZeneca and Johnson & Johnson, while the nucleic acid vaccine team handles vaccines from Pfizer and Moderna.

Vaccine developers can submit quality, non-clinical, and clinical data to the MFDS as soon as they are prepared to receive a preliminary review before the approval application. Through this process, the MFDS expects to secure sufficient time to thoroughly assess the safety and efficacy of the vaccines and reduce the review period after the approval application by up to 40 days.

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