ワクチンについて、「安全性が確認された」という言葉を見たり聞いたりすることがあります。しかし、「安全性が確認された」と「安全である」という言葉は同じではありません。この違いは、インフルエンザワクチンPandemrixやコロナワクチンにも見られるように、非常に重要な問題を含んでいます。本記事では、この言葉の違いとミスリーディングの問題について考えます。
Pandemrixの教訓
Pandemrixは2009年のH1N1インフルエンザパンデミック時に、迅速に開発されました。このワクチンは緊急承認され、主にヨーロッパで約3,100万人に接種されました。しかし、その後、特に北欧諸国でナルコレプシーのリスクが報告されました。経緯は、European Medicines Agencyの文書や論文「The Rotavirus Vaccine Story: From Discovery to the Eventual Control of Rotavirus Disease」などで詳しく述べられています。
- 試験の規模と結果:
- 第III相試験には約5,000人の成人が参加し、接種後の抗体価の上昇が確認されました。
- 接種後の局所的な痛み（25%以上）や軽度の発熱（10%以上）が最も一般的な副反応として報告されました。
- しかし、非常にまれな事象（例: ナルコレプシー）は、この試験規模では検出されませんでした。
- 承認後の影響:
- フィンランドでは、Pandemrix接種者のナルコレプシー発症リスクが接種しなかった人と比べて約13倍増加したというデータが報告されています（1/16,000の発生率）。
- Pandemrixには、独自アジュバント「AS03」が使用されており、一部の研究では、AS03が自己免疫反応を引き起こし、特に特定の遺伝的背景を持つ人々でナルコレプシーの発症リスクを増加させる可能性が示唆されています。
- 他の北欧諸国でも同様の傾向が確認され、使用は中止されました。
このケースは、「限られた条件で安全性が確認された」としても、その条件外でのリスクが見逃される可能性があることを示しています。
Meiji Seikaファルマの新型コロナワクチンに潜む課題
同様の問題は、現在開発中のワクチンにも当てはまります。たとえば、Meiji Seikaファルマが開発したコロナワクチンでは、審査報告書にあるように、添加剤としての使用前例がないATX-126や、筋肉内投与での使用前例がないソルビン酸カリウムが含まれています。
これらの物質が「安全」であると結論づけることは難しく、現時点で可能なのは「特定の条件下で安全性が確認された」という限定的な評価だけです。Pandemrixの例と同様、実際の運用に入って初めて未知のリスクが発見される可能性があります。自己増殖型に関わるリスクだけではありません。
「安全性の確認」と「安全」の違い
ワクチン研究者や製薬会社は、慎重に言葉を選び、「安全である」とは断言せず、「安全性を確認した」と述べることが一般的です。これは科学的に正確であり、倫理的にも正しいアプローチです。しかし、この言葉が一般の人々に伝わる過程で、しばしば「安全である」と解釈されることがあります。
ここで難しいのは、一般の人々に科学的な不確実性を含む「条件付きの安全性」を理解してもらうことです。Pandemrixや他のワクチンの例は、安全性評価がいかに複雑で、かつ不完全であるかを示しています。しかし、それを正直に伝えれば、ワクチン接種をためらう人が増え、結果として社会全体にリスクをもたらす可能性があります。
条件付きの安全性のみが示されることで、不確かな情報が拡散する余地が生まれます。Meiji Seikaファルマはこのような状況に対して、「あなたのことを良く知るかかりつけ医やお近くの医療機関にご相談下さい」としています。
また、東洋経済オンラインの記事で、Meiji Seika ファルマ社長は、
「打つ、打たないは本人の自由です」だと、リスクを超えて打つ人は誰もいなくなる。「打つべきです、ただ、一定の率で重い副反応はありますよ」として、その後はご自身で考えてもらう。
と述べた旨が書かれています。
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