ヴァリチェッラワクチンの許可後の安全性監視
R P Wise1, M E Salive, M M Braun
1Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, FDA CBER HFM-225, Rockville, MD 20852-1448, USA. rpwise@cber.fda.gov
JAMA
|September 9, 2000
まとめ
Varicellaワクチンは一般的に安全であり,ほとんどの有害事象は軽微です. 重篤なリスクは稀ですが,いくつかのイベントやワクチン使用教育を改善するためにさらなる研究が必要です.
科学分野:
- 免疫学 免疫学とは
- ワクチン学 ワクチン学
- 公衆衛生は公衆衛生である.
背景:
- 1995年以来,ワクチンの使用に関する認可後の広範な監視により,希少な有害事象の検出が可能です.
- 臨床試験は,稀なリスクを特定するためのサンプルサイズに制限があります.
研究 の 目的:
- Varicellaワクチンに関連した潜在的な危険とまれな出来事を特定するために.
- 報告された有害事象の臨床的および疫学的重要性を評価する.
主な方法:
- 認可後のケース・シリーズ研究では,米国ワクチン有害事象報告システム (VAERS) に報告された疑わしい有害事象を分析した.
- 1995年3月17日から1998年7月25日まで収集されたデータ.
- 分析には,有害事象のカウント,比率,および100,000用量あたりの報告率が含まれていました.
主要な成果:
- 6574件の有害事象報告が受けられました (10万回の投与量につき67.5件).
- 報告の約4%が重症で,そのうち14人が死亡しました. 発疹や注射部位での反応が一般的であった.
- ワクチンの失敗の可能性とヘルペス・ゾスターの症例を分析し,ワクチンまたは野生型の疹ゾスターウイルス (VZV) に関連しているケースもありました.
結論:
- 報告されている大抵の水ワクチンの有害事象は軽微であり,深刻なリスクは稀に発生する.
- 最も深刻なイベントの因果関係は未確認であり,さらなる調査が必要である.
- Varicellaの血清学的解釈と,ワクチンとVaricella zosterの免疫グロブリンを区別することに関して,教育の改善が必要である.
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