[Press Release Feb. 27, 2021 / Unofficial Translation]


MFDS Begins Review of Janssen Korea’s COVID-19 Vaccine


□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that on February 27, Janssen Korea (Johnson & Johnson) filed for marketing authorization of its COVID-19 vaccine (Ad26.COV2S).
○ Janssen Korea’s single dose regimen vaccine is one of the COVID-19 vaccines that the Korean government planned to import.
- The vaccine is a viral vector vaccine, as is that of AstraZeneca Korea, manufactured by inserting the spike protein gene of a pathogenic virus into adenovirus platform.

○ The MFDS will decide whether to grant marketing authorization for Janssen Korea’s COVID-19 vaccine, after meticulously reviewing submissions - including clinical, nonclinical and quality data, and the GMP report - and the three-tier advisory review in the meetings of the Advisory Committee for the Safety and Efficacy Assessment of COVID-19 Vaccine, the Central Pharmaceutical Advisory Committee and the Final Evaluation Committee.
* The rolling review on nonclinical and quality data of Janssen Korea’s COVID-19 vaccine is currently ongoing (since Dec. 22, 2020).

○ The Janssen COVID-19 vaccine is the third COVID-19 vaccine for which the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) recommended Emergency Use Authorization (EUA) as of on Jan. 26, 2021, local time.

□ The MFDS will continuously put its utmost effort into swiftly providing safe and effective COVID-19 vaccines to the people of Korea.