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The Central Pharmacy Review Committee of the Ministry of Food and Drug Safety recommended the approval of the article for the Corona 19 ‘Cominatiju’ vaccine developed by Pfizer / Bioentech. It was also suggested that the efficacy and safety of adolescents aged 16 to 17 years are not different from those of adults, so it is reasonable to include them in the approval age.
Director Lee Dong-hee of the Korea Food and Drug Administration (KFDA) revealed the results of the meeting of the Central Pharmaceutical Review Committee (hereinafter referred to as “ Central Drug Review ”) of the Ministry of Safety of Food and Medicines through an information session on the 26.
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), the safety and efficacy of the vaccine, for the ‘Cominatiju’ application, which Pfizer Korea applied for permission after consulting the full views of the experts on general licensing issues, including ways to ensure safety.
This meeting of the Central Pharmacopoeia was held with 19 external experts, including 13 permanent members of the Subcommittee on Biological Medicines, which is a specialized subcommittee for deliberation on the safety and efficacy 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, from the ‘Crisis Response Support Division’ vaccine review team attended.
As a result of discussing whether or not the safety and efficacy of this medicine is recognized through the data submitted for the ‘Cominati Province’ product approval application, 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. · By synthesizing the results of the effectiveness verification of the advisory group, it is possible to approve the item ”.
In particular, based on the preventive effect confirmed in the results of clinical trials aged 16 years and over, he presented an opinion that “it is reasonable to grant approval for subjects aged 16 years or over in the same way as the and effect of the application “.
However, considering the fact that the immune response of adolescents over 16 years of age is not different from that of adults, so data from clinical trials in adults are available, ‘The effectiveness and safety in adolescents aged 16 to 17 years are extrapolated from adult data in Korea as well as in the United States. It was recommended to include in the permit information
As with the previous verification advisory group opinion, the Central Pharmacopoeia said: “The safety profile (trend), such as abnormal cases that occurred in clinical trials, is acceptable, but close follow-up is necessary after testing. administration for those with a history of hypersensitivity, including anaphylaxis “. It was an opinion and it was recommended that reported abnormal cases be clearly reflected in permitting issues.
Furthermore, the efficacy of the vaccine was confirmed in the data presented, so the preventive effect for approval was considered sufficient.
The central pharmacist said: “It is appropriate to ensure general safety and it is reasonable to continuously monitor safety, such as anaphylaxis and lymphadenopathy, through a risk management plan after approval, and to continuously collect and evaluate information on the abnormal cases that appear during tests. “
The Ministry of Food and Drug Safety synthesizes the expert opinions, efficacy / effects (proposal), use / dose (proposal) and recommendations obtained from the verification advisory group and this Central Pharmacopoeia consultation, and provides a final verification of the quality data of ‘Cominatiju’. After reviewing the additional materials required, the ‘Final Inspection Committee’ will be held to make a final decision on approval.
