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It only needs to be hit once… Ministry of Food and Drug Safety Janssen vaccine license review started

Janssen (Johnson & Johnson) Corona 19 Vaccine./ Photo = Yonhap News

The Ministry of Food and Drug Safety announced on the 27th that Janssen (Johnson & Johnson) has initiated a vaccine approval review for the novel coronavirus infection (Corona 19). Earlier, Janssen applied for a COVID-19 vaccine item license from the Food and Drug Administration.

The Ministry of Food and Drug Safety checks the safety and effectiveness of external experts such as the Verification Advisory Group, the Central Pharmacist Review Committee, and the Final Inspection Committee, and then decides whether to approve the Janssen vaccine. Janssen is already undergoing non-clinical and quality data review from December 22nd last year.

Janssen vaccine is a’viral vector vaccine’ manufactured by putting the corona 19 virus surface antigen gene into an adenovirus template. It is manufactured on the same platform as the AstraZeneca product that has already been inoculated in Korea, and has the advantage of easy storage and distribution as it can be stored at 2-8 degrees.

In addition, it is the only one of the five vaccines that come into Korea and can be effective even with one dose. Both AstraZeneca, Pfizer, and Modena vaccines require two doses. The preventive effect is in the 66-85% level. It is relatively low compared to Pfizer/Moder or vaccines, which show 95% effectiveness.

The government has signed a contract with Janssen to introduce 6 million vaccines. The vaccine will enter Korea in earnest from the second quarter of this year.

Meanwhile, the U.S. Food and Drug Administration (FDA) advisory body recommended urgent use of Janssen vaccine as the third Corona 19 vaccine in the U.S. on the 26th (local time).

Shin Hyun-ah, Hankyung.com reporter [email protected]

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