MFDS Begins Preliminary Review of Janssen COVID-19 Vaccine

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jung] The Ministry of Food and Drug Safety announced on the 22nd that Janssen (Johnson & Johnson) has applied for a preliminary review before submitting a COVID-19 vaccine approval application.

Janssen's vaccine is one of the vaccines included in the government's procurement plan.

This is the third preliminary review application for non-clinical and quality data, following the Pfizer vaccine and the AstraZeneca vaccine.

The Ministry of Food and Drug Safety plans to conduct a preliminary review of the vaccine's toxicity, pharmacology, and quality data through the dedicated approval review team, the 'Virus Vector Vaccine Team.'

To prepare for domestic approval applications for COVID-19 vaccines, the Ministry has organized and is operating two dedicated approval review teams for expedited review: the Virus Vector Vaccine Team and the Nucleic Acid Vaccine Team.

Vaccine developers can submit data on quality, non-clinical, and clinical studies to the Ministry as soon as they are ready to receive a preliminary review before the approval application.

The Ministry expects that this process will secure sufficient time to thoroughly review the vaccine's safety and efficacy and minimize the review period after the approval application is submitted.