Corona 19 vaccination (data photo: 2020.12.15)ⒸAP/Newsis
A preliminary review of the products of AstraZeneca, Janssen (Johnson & Johnson), and Pfizer, a foreign pharmaceutical company that developed a novel coronavirus infection (Corona 19) vaccine, is currently in progress. In addition, an application for approval for use of the antibody treatment agent being developed by Celltrion, a domestic company, will be made during this month.
The Ministry of Food and Drug Safety announced on the 27th that it will shorten the approval review period from 180 days to 40 days, explaining the approval process for new vaccines and treatments currently being developed at home and abroad.
In the case of a foreign company’s Corona 19 vaccine clinical trial, a number of companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase 3 clinical trials. As of the 25th, the Pfizer vaccine has been approved for emergency use in eight countries, including the United States and the United Kingdom, and conditionally licensed in the European Union and Switzerland. The Modena vaccine has been approved for emergency use in the United States. Three vaccines developed by foreign pharmaceutical companies are currently undergoing preliminary review by the Ministry of Food and Drug Safety.
It was found that five companies, including the International Vaccine Research Institute, SK Bioscience, Celid, Jinwon Life Science, and Genexine, are conducting initial clinical trials for the domestic Corona 19 vaccine.
In the case of COVID-19 treatment, Lily and Regeneron are conducting phase 3 clinical trials for antibody treatments, and they have been approved for emergency use in the United States. In Korea, 15 products were found to be undergoing clinical trials. The Ministry of Food and Drug Safety confirmed that Celltrion’s antibody treatment was “planned to apply for use within this month.”
For new drugs, the final approval is decided by combining the review results of experts in each field and the advisory opinions of external experts such as the Central Pharmacy Review Committee if necessary. The Ministry of Food and Drug Safety announced that it aims to shorten the existing treatment period by 180 days or more and process it within 40 days through a preliminary review of each item for Corona 19 vaccines and treatments, and a prompt approval review by a dedicated approval review team.
Reporter Ko Hee-cheol
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