英国におけるCOVID-19 パンデミックにおける積極的なワクチン安全監視の実施と結果:規制の観点
Jenny Wong1, Katherine Donegan1, Kendal Harrison1
1Medicines and Healthcare products Regulatory Agency (MHRA), Safety and Surveillance, 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.
Drug safety
|September 3, 2025
まとめ
イエローカードワクチンモニター (YCVM) は,多くのユーザーで予想される反応を発見し,COVID-19 ワクチンの安全性を積極的に追跡しました. このシステムは規制の警戒を強めたが,特に少数民族の採用は必要である.
科学分野:
- 薬剤監視と医薬品の安全性
- ワクチンモニタリング
- 公衆衛生の監視
背景:
- イギリスの医薬品およびヘルスケア製品規制局 (MHRA) は,COVID-19ワクチンの副作用の積極的な監視のためにイエローカードワクチンモニター (YCVM) を設立しました.
- YCVMは,臨床試験で不足している集団におけるワクチンの安全性を特徴づけることを目的とした.
研究 の 目的:
- YCVMプラットフォームに登録された個人の人口プロフィールを調査する.
- YCVM プラットフォームを通じて,COVID-19 ワクチン接種後に報告された疑わしい副作用を分析する.
主な方法:
- 層格化されたランダムサンプリングを使用して,個人を登録し,ワクチンおよび経験した副作用に関する情報を提供するよう招待しました.
- 2020年11月から2022年12月までのYCVM登録者の人口統計と副作用データを調査分析で特徴づけました.
- 妊婦と授乳中の女性を詳細に分析し,また,月経障害と tinnitus を規制評価のために特定した.
主要な成果:
- 36, 604人が登録され,30281人がワクチン接種を報告し,52. 1%が少なくとも1つの有害反応を経験し,そのほとんどは急性であった.
- 妊婦および授乳中の女性では安全性に関する懸念は認められませんでした.
- 月経障害の報告はメディアの注目によって影響を受け,耳鳴りデータは規制措置を支持した.
結論:
- YCVMによる積極的な監視は,COVID-19ワクチンの安全性モニタリングのための貴重な補完的なデータ源として機能します.
- YCVMでは少数民族の採用を強化する必要があります.
- 開発された技術は規制の警戒を向上させ,小規模な集団における新製品のモニタリングの可能性を秘めています.
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