Janssen COVID-19 Vaccine, First Expert Advisory on the 28th

[Asia Economy Reporter Hyunseok Yoo] The Ministry of Food and Drug Safety (MFDS) announced on the 26th that the first expert advisory meeting for the approval and review of the Janssen COVID-19 vaccine will be held on the 28th. The results will be disclosed at 10:20 a.m. on the following day, the 29th.

The MFDS follows a triple external expert advisory process consisting of a verification advisory group, the Central Pharmaceutical Affairs Deliberation Committee, and the final inspection committee to ensure objective and transparent approval and review of COVID-19 treatments and vaccines.

Janssen, the pharmaceutical division of Johnson & Johnson, officially applied for the approval of the COVID-19 vaccine to the MFDS on the 27th of last month. This product is a "virus vector vaccine" manufactured by inserting the gene of the COVID-19 virus surface antigen into an adenovirus template that infects only chimpanzees. It is the only COVID-19 vaccine to be introduced domestically that was developed for single-dose administration.

The MFDS began a preliminary review of the non-clinical trial and quality data of the vaccine from December 22 of last year, prior to Janssen’s formal application for approval.

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