The Third Domestic Vaccine Approval Process Begins... Janssen Vaccine

Janssen (Johnson & Johnson) COVID-19 Vaccine [Image source=AFP Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Following AstraZeneca and Pfizer COVID-19 vaccines, the Janssen (Johnson & Johnson) vaccine has become the third to begin the approval process in South Korea.

The Ministry of Food and Drug Safety announced on the 27th that Janssen (Johnson & Johnson) has applied for approval of its COVID-19 vaccine (code name: Ad26.COV2S).

This vaccine is the one the government announced it would import for 6 million people in the second quarter. Unlike other vaccines that require two doses, it is effective with just one dose. It is a 'viral vector vaccine' manufactured by inserting the gene for the COVID-19 virus surface antigen into an adenovirus vector, using the same platform as the previously approved AstraZeneca vaccine.

The Vaccines and Related Biological Products Advisory Committee, an advisory body to the U.S. Food and Drug Administration (FDA), recommended emergency use authorization on the 26th (local time) as the third COVID-19 vaccine for use in the United States.

The Ministry of Food and Drug Safety has been conducting a preliminary review of non-clinical and quality data for the Janssen vaccine since December last year. It will carefully examine the submitted quality, non-clinical, clinical, and GMP data, and after triple advisory reviews by the COVID-19 vaccine safety and efficacy verification advisory group, the Central Pharmaceutical Review Committee, and the final inspection committee, it will confirm the product's safety and efficacy to decide on approval.

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