[Asia Economy Reporter Seo So-jung] The Central Pharmaceutical Affairs Deliberation Committee of the Ministry of Food and Drug Safety has issued an advisory opinion that Pfizer's COVID-19 vaccine can be approved for individuals aged 16 and older.
On the 26th, the Ministry of Food and Drug Safety announced that the Central Pharmaceutical Affairs Deliberation Committee comprehensively discussed and reviewed the safety and efficacy of Korea Pfizer's "Comirnaty" and advised that it could be approved.
Previously, the Central Pharmaceutical Affairs Deliberation Committee meeting was held at 2 p.m. the day before at the Ministry of Food and Drug Safety headquarters in Osong, Chungbuk. This meeting included 19 external experts: 13 standing members of the Biologics Subcommittee, a specialized subcommittee for vaccine safety and efficacy review; 5 verification advisory members; and 1 expert recommended by the Korean Medical Association. Additionally, 8 internal members from the Ministry’s COVID-19 Crisis Response Support Headquarters vaccine review teams?comprehensive review, clinical review, and quality review teams?attended.
Based on the preventive effects confirmed in clinical trials including those aged 16 and older, the Central Pharmaceutical Affairs Deliberation Committee expressed the opinion that it is reasonable to approve the vaccine for those aged 16 and above, consistent with the requested indications and efficacy.
Furthermore, considering that the immune response in adolescents aged 16 and older is not different from that of adults, it was recommended that the approval include a statement that "the efficacy and safety in adolescents aged 16 to 17 were extrapolated from adult data," aligning with the U.S. approval.
The Central Pharmaceutical Affairs Deliberation Committee stated, in agreement with the verification advisory group, that the safety profile (including adverse events observed in clinical trials) is at an acceptable level.
However, it was noted that individuals with a history of hypersensitivity, including anaphylaxis, require close monitoring after administration, and it was recommended that reported adverse events be clearly reflected in the approval documentation.
Regarding efficacy, the committee concurred with the verification advisory group that the submitted data confirmed the vaccine’s preventive effect, deeming it sufficient for approval. Pfizer’s vaccine efficacy is approximately 95%.
After approval, it was advised that safety continue to be monitored through a "Risk Management Plan," including anaphylaxis and lymphadenopathy, and that adverse events observed during clinical trials be continuously collected and evaluated.
The Ministry of Food and Drug Safety plans to hold a "Final Review Committee" to make the final decision on approval after reviewing expert opinions obtained from the COVID-19 Vaccine Safety and Efficacy Verification Advisory Group and the Central Pharmaceutical Affairs Deliberation Committee, as well as indications, dosage, recommendations, and additional submitted materials necessary for the final quality check of Comirnaty.
The Ministry operates a "triple" advisory process for COVID-19 vaccine approval, including the Verification Advisory Group, Central Pharmaceutical Affairs Deliberation Committee, and Final Review Committee.
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