■モデルナ製ワクチン、混入異物はステンレススチール ３ロット番号163万回分を自主回収へ

　日本に出荷されたアメリカの製薬大手モデルナ製の新型コロナウイルスワクチンの一部から異物が見付かり、全国で３ロット番号約160万回分の使用を見合わせている問題で、厚生労働省は製造工程でステンレススチールが混入したとするモデルナ側の調査結果を公表しました。
　モデルナのヨーロッパにおける委託生産拠点であるスペインのロビ・ファーマ・インダストリアル・サービスの製造ラインにおける部品の設置ミスが原因とみられ、使用を見合わせているワクチンは２日以降すべて自主回収されます。
　８月中旬以降、全国の複数の接種会場で、モデルナのワクチンの未開封の容器の一部に、粒子状の異物が混入しているのが見付かりました。
　厚労省は、同時期に同じ工程で製造され、全国901の会場に配送された合わせて163万回分のワクチンの使用を見合わせています。
　厚労省によりますと１日、モデルナ側から、異物はステンレススチール製の製造部品の破片だったとする調査結果が報告されました。
　製造工程で、部品同士が設置ミスによって接触し、摩擦で削り取られて混入したということです。
　国内での販売・流通を手掛ける武田薬品工業は厚労省と対応を協議し、使用を見合わせているワクチンを２日からすべて自主回収することを決めました。
　一方、混入したステンレススチールの破片はごく少量で、人工関節やペースメーカーなどの医療機器にも使用されている物質のため、接種しても健康に重大な影響を与える可能性は低いとしています。
　このほか沖縄県と群馬県、東京都、神奈川県でもモデルナのワクチンの容器から異物が見付かっていますが、いずれも容器のふたのゴム片で製造工程や開封時に混入した可能性が高く、安全性に問題はないとする調査結果が公表されています。
　アメリカの製薬大手モデルナは、日本での販売・流通を手掛ける武田薬品工業と連名でコメントを発表しました。
　この中で、「注射針を通過できる大きさの粒子状金属が仮に筋肉内に注入されてしまった場合、接種された局所における反応を引き起こす可能性があるが、注射部位以外での副反応を起こす可能性は低いと考えられている。今後は、製造工程での目視による総点検の徹底など再発防止に努める」としています。
　また、８月、実際に異物の混入が確認されたロット番号ではないものの混入の可能性が否定できないとして使用を見合わせているワクチンを接種された30歳代の男性２人が死亡したことについて、「接種との因果関係は不明で、現時点では相互の関係なく偶発的に起きたと考えられる。最終的な判断は厚生労働省による正式な調査結果が出るのを待ちたい」としています。

　２０２１年９月３日（金）

タグ：健康創造塾 ニュース 健康ダイジェスト

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