An illustration of a global pharmaceutical company Johnson & Johnson-Jansen’s COVID-19 vaccine. Reuters = Yonhap News
The new coronavirus infection (Corona 19) vaccine (codename Ad26.COV2S) of Janssen in the United States is going through the domestic approval process. The Ministry of Food and Drug Safety announced on the 27th that Janssen applied for a vaccine item license.
Can be distributed through general cold chain
Ministry of Food and Drug Safety, plans to examine data on quality, clinical, etc.
According to the Ministry of Food and Drug Safety, the Janssen vaccine only needs to be given once, unlike AstraZeneca and Pfizer vaccines that are currently being vaccinated in Korea. Distribution and storage are also an advantage. Cryogenic distribution facilities at -70 degrees Celsius level are not required. A normal cold chain of 2 to 8 degrees is sufficient. It can be stored for 2 years at -20 degrees Celsius. However, in clinical trials, the preventive effect was found to be 66~85%. It is relatively lower than that of Pfizer/Moder or vaccine (95%).
The Korean government has signed a purchase contract with Janssen for 6 million people. The volume is expected to come in sequentially from April.
From the first confirmation of Corona 19 to vaccination. Graphic = Reporter Jaemin Shin [email protected]
The approval of an item from the Ministry of Food and Drug Safety is a procedure to confirm the safety and effectiveness of a new drug. It consists of six steps, from reception to preliminary review → review → external expert consultation → final permission → national shipment approval. It takes less than 40 days. Expert consultation goes through a triple consultation process again. Starting with the safety and effectiveness verification advisory group, the central pharmacist review committee and the final inspection committee. In the case of Pfizer, the final inspection committee is ahead.
An official from the Ministry of Food and Drug Safety said, “We plan to closely review the quality, non-clinical, and clinical data submitted by Janssen to confirm the safety and effectiveness of the product.”
Meanwhile, the Vaccine Biological Drug Advisory Committee, an advisory body of the US Food and Drug Administration (FDA), recommended approval for emergency use of Janssen vaccine on the 26th (local time).
Reporter Minwook Kim [email protected]
