The final inspection committee is held and the product is approved as a condition of submitting the final report
The Ministry of Food and Drug Safety (Director Kang-Rip Kim) decided to approve the product for Pfizer’s Corona 19 Vaccine Cominati, subject to the submission of the final clinical trial results.
The Ministry of Food and Drug Safety held a final inspection committee at 10 am today (5th) to make a final decision on whether to approve the corona 19 vaccine item.
The meeting was attended by three external experts, including Chairman Yoo-hwan of the Central Pharmacopoeia, and five members, including the head of the Ministry of Food and Drug Safety.
The final inspection committee decided on product approval under the condition of comprehensively reviewing the results of the KFDA examination and the contents of the previous two consultations, and submitting the final results of clinical trials for Cominati Province after approval.
Most of the adverse events reported on the safety of Cominati were predicted adverse events related to vaccine administration, and were judged to be generally good.
However, for those with a history of hypersensitivity, including anaphylaxis, it is necessary to closely monitor after permission, and it is planned to reflect additionally on permission matters for abnormal cases reported in the future.
It was judged that the preventive effect of coma is sufficient, and as a result of clinical trials, 8 vaccine groups and 162 control groups were each confirmed as corona 19, showing a preventive effect of about 95%.
The final review committee said ▲The clinical trial was designed to confirm safety and effectiveness in subjects over 16 years of age, and the preventive effect was confirmed. It is possible and ▲ considering the fact that a number of countries such as the United States, Europe (EU), the United Kingdom, and Japan have allowed them to be 16 years of age or older, he advised that it is reasonable to grant permission to those aged 16 or older.
However, it was decided to continue to monitor the safety of anaphylaxis and lymphadenopathy through the risk management plan even after approval, and to continuously collect and evaluate abnormal cases arising from clinical trials in progress and use after approval.
Copyright © Unauthorized reproduction and redistribution of medical news is prohibited.