[Press Release, Dec 22, 2020 / unofficial translation ]

MFDS begins rolling reviews of Janssen’s (Johnson & Johnson’s) COVID-19 vaccine

□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announced that Janssen (Johnson & Johnson) applied for a rolling review of its COVID-19 vaccine on Dec. 22.
○ The vaccine is one of the vaccines which the Korean government proclaimed to purchase in the future. The manufacturer requested a rolling review of submitted non-clinical and quality data.
○ Accordingly, “viral vector vaccine team,” which is a task force team* for approval, will carefully evaluate the toxicity, pharmacology and quality data of the vaccine prior to the submission.
* MFDS has been operating two task force teams (viral vector vaccine team and nucleic acid vaccine team) to expedite the approval process of COVID-19 vaccines for domestic use.
□ Vaccine developers can submit quality, non-clinical, and clinical data to MFDS as soon as they become available to request for a rolling review before the formal submission of application.
○ MFDS expects that such processes would help to ensure enough time for the Ministry to conduct thorough reviews on the safety and efficacy of vaccines and reduce the review period starting from the application date to 40 days at shortest.

□ MFDS said it is committed to doing its utmost to swiftly supply safe and effective vaccines to the people of Korea.