[엠디데일리] The Ministry of Food and Drug Safety’s verification advisory group said on the 23rd that Pfizer’s Corona 19 vaccine coma has a protective effect of 94% or more regardless of age and underlying disease.
On the 23rd, the Ministry of Food and Drug Safety explained the progress of the item approval of Pfizer’s Corona 19 vaccine’Cominatiju’ at the meeting room of the Ministry of Food and Drug Safety in Cheongju, Chungbuk.
On the 22nd, the Ministry of Food and Drug Safety previously held a COVID-19 vaccine safety and effectiveness verification advisory meeting with seven participants including infectious medicine specialists, vaccine specialists, and clinical statistics specialists on the results of clinical trials in Pfizer, Korea.
On this day, the verification advisory group said ▲The clinical trial was designed to confirm safety and effectiveness in subjects over 16 years of age, and the preventive effect was confirmed ▲The point that it is judged that the immune response of adolescents aged 16-17 will not be different from that of adults ▲Adult clinical trial The availability of test data ▲Considering that a number of countries such as the United States, Europe, the United Kingdom, and Japan have allowed them to be 16 years of age or older, they expressed an opinion that it is reasonable to permit those over the age of 16.
In addition, regarding the adverse events that occurred in clinical trials, the safety profile, that is, the trend, was judged to be acceptable in clinical trials, but he suggested that careful monitoring after vaccination is necessary for those with a history of anaphylaxis.
In particular, the verification advisory group determined that the effectiveness was confirmed in the data submitted on the preventive effect of the vaccine, and the immune response was also maintained higher than the antibody in the plasma of the cured person during natural infection, so the preventive effect was sufficient.
In addition, he suggested that it is appropriate to continuously monitor the safety of anaphylaxis and other abnormalities through the risk management plan after approval, and to continuously collect and evaluate information about abnormal cases that appeared during clinical trials.
Accordingly, the Ministry of Food and Drug Safety is planning to conduct a review of quality data related to Pfizer’s coma in Korea, and to synthesize expert opinions and recommendations obtained through this verification advisory meeting and the review results.
On the other hand, the Ministry of Food and Drug Safety is scheduled to receive advice from the Central Pharmacy Review Committee, the legal advisory body of the Ministry of Food and Drug Safety, on the safety, effectiveness, and matters to be considered when permitting the requested item, and the results will be disclosed on the 26th.
Reporter Lee Young-bok 48yblee
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