The Ministry of Food and Drug Safety is widely collecting opinions from authoritative experts in various fields in order to secure expertise and objectivity in the approval process of the Corona 19 vaccine, and this time, extensive consultation was made on Pfizer’s Corona 19 vaccine’Cominati .
The Ministry of Food and Drug Safety (Director Kang-rip Kim) held a meeting of the’Central Pharmacy Review Committee’ at the headquarters of the Food and Drug Administration in Osong, Chungbuk on the 25th to advise on the safety and effectiveness of Pfizer Pharmaceutical Co., Ltd.’s’Cominatiju’.
This central pharmacy review committee meeting was held with 19 external experts including 13 standing members of the Biological Medicines 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. Eight members attended the’Corona 19 Crisis Response Support Division’, including the general review team, clinical review team, and quality review team of the vaccine review team.
In accordance with Article 18 of the’Pharmaceutical Affairs Act’ regarding the safety and effectiveness of newly used drugs, the’Central Pharmacist Review Committee’ is being operated to seek advice.In consideration of the severe situation of the Corona 19 pandemic,’Corona 19 Vaccine/treatment safety/effectiveness verification advisory group’ and’final inspection committee’ were additionally formed to go through a triple consultation process.
At this meeting of the Central Pharmacy Review Committee, whether it is appropriate to approve the product by acknowledging the safety and effectiveness of this drug based on submitted data such as clinical trial data for’Cominatiju’, the efficacy and effectiveness of the application (16 years of age or older) will be evaluated. We consulted the experts’ comprehensive views on overall licensing matters, such as appropriateness, opinions on the safety and effectiveness of vaccines, and ways to secure safety after approval.
In addition, the Central Pharmacy Review Committee discussed whether the safety and effectiveness of this drug was recognized through the data submitted by Pfizer Korea Co., Ltd. for the application for product permission of’Cominati’. The necessity was acknowledged, and it was advised that the product could be approved when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group.
Based on the preventive effect confirmed in the results of clinical trials including 16 years of age or older, the opinion was that it would be appropriate to grant permission for subjects 16 years of age or older in the same manner as the application efficacy and effect.
Considering that the immune response of adolescents over 16 years old is not different from that of adults, and considering the availability of adult clinical trial data, it is said that’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.
Consistent with the opinion of the verification advisory group,’the safety profile (propensity) such as abnormal cases that occurred in clinical trials is acceptable, but it is an opinion that close monitoring after administration is necessary for people with a history of hypersensitivity, including anaphylaxis. It was recommended that the above cases be clearly reflected in permission matters.
As with the opinion of the verification advisory group, the effect was confirmed in the submitted data on the preventive effect of the vaccine, so it was judged that the preventive effect for approval was sufficient.
The overall safety security plan was appropriate, and it was appropriate to continuously monitor the safety of anaphylaxis and lymphadenopathy through the’risk management plan’ after approval, and to continuously collect and evaluate information about abnormal cases that appeared during clinical trials.
In synthesizing the opinions of the Central Pharmacy Review Committee, opinions were gathered that Pfizer Korea Co., Ltd.’s’Cominatiju’ could be approved as an item.
The Ministry of Food and Drug Safety is synthesizing expert opinions, efficacy and effects (proposal), usage and dosage (proposal), recommendations, etc. obtained through consultations with the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ and the’Central Pharmacy Review Committee’. After reviewing the additional submitted data necessary for the final inspection, such as the quality data of’Cominati Province’, the’Final Inspection Committee’ will be held to make a final decision on whether to permit or not.
Along with this, he announced that he will make efforts to ensure objectivity and transparency by collecting various experts’ opinions in the approval process of COVID-19 treatment and vaccines, while ensuring thorough approval and review. Reporter Kang Kyung-nam
