The Ministry of Food and Drug Safety’s Central Pharmacy Review Committee recommended the approval of the item for the Corona 19 vaccine’Cominatiju’ developed by Pfizer/Bioentech. It was also suggested that the efficacy and safety of adolescents aged 16 to 17 are not different from those of adults, so it is reasonable to include them in the age of approval.
Director Lee Dong-hee of the Korea Food and Drug Administration (KFDA) revealed the results of the Central Pharmacist Review Committee (hereinafter referred to as “Central Medicines Review”) meeting of the Ministry of Food and Drug Safety through a briefing on the 26th.
On the 25th, the Ministry of Food and Drug Safety held a meeting of the Central Pharmacopoeia at the headquarters in Osong, North Chungcheong Province, and approved the adequacy of the efficacy and effectiveness of the application (over 16 years of age), the safety and effectiveness of the vaccine, for the application of’Cominatiju’, which Pfizer Korea applied for permission After consulting the experts’ comprehensive views on overall licensing matters, including ways to secure safety.
This Central Pharmacopoeia meeting was held with 19 external experts, including 13 standing members of the Biological Drug Subcommittee, which is a specialized subcommittee for deliberation on the safety and effectiveness of vaccines, 5 verification advisory groups, and 1 expert recommended by the Korean Medical Association. 19 Eight members, including the general review team, clinical review team, and quality review team, of the’Crisis Response Support Division’ vaccine review team attended.
As a result of discussing whether or not the safety and effectiveness of this drug is recognized through the data submitted for the product approval application of’Cominati Province’, the Central Pharmacopoeia said, “The need for the purpose of preventing Corona 19 in Korea was recognized, and the safety of the Corona 19 vaccine. · When synthesizing the results of the advisory group’s effectiveness verification, it is possible to approve the item.”
In particular, based on the preventive effect confirmed in the results of clinical trials involving 16 years of age or older, he presented an opinion that “it is reasonable to grant approval for subjects 16 years of age or older in the same manner as the efficacy and effect of the application.”
However, considering the fact that the immune response of adolescents over 16 years old is not different from that of adults, so that the clinical trial data of adults are available,’Effectiveness and safety in adolescents aged 16 to 17 are extrapolated from the data of adults’ in Korea as in the United States. It was recommended to include in the permission information.
As with the opinion of the previous verification advisory group, the Central Pharmacopoeia said, “The safety profile (trend), such as abnormal cases that occurred in clinical trials, is acceptable, but close monitoring after administration is necessary for those with a history of hypersensitivity, including anaphylaxis.” Was an opinion, and it was recommended that the reported abnormal cases should be clearly reflected in permission matters.
In addition, the effectiveness of the vaccine was confirmed in the submitted data, so it was judged that the preventive effect for approval was sufficient.
The Central Pharmacist said, “It is appropriate to ensure overall safety, and it is reasonable to continuously monitor the safety such as anaphylaxis and lymphadenopathy through a risk management plan after approval, and to continuously collect and evaluate information on abnormal cases that appear during clinical trials.” .
The Ministry of Food and Drug Safety synthesizes expert opinions, efficacy/effects (proposal), usage/dose (proposal), and recommendations obtained from the verification advisory group and this Central Pharmacopoeia consultation, and provides a final check on the quality data of’Cominatiju’. After reviewing the required additional submitted materials, the’Final Inspection Committee’ will be held to make a final decision on approval.