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■熊本の製薬会社開発ワクチン、12歳未満向け治験も検討 [健康ダイジェスト]

 明治ホールディングス傘下のKMバイオロジクス(熊本市)は25日、開発する新型コロナウイルスワクチンの子供向け臨床試験(治験)を2022年春にも始めると発表しました。これまで国内でワクチン接種の対象になっていない乳幼児や12歳未満向けも検討します。18歳以上向けでは、早期に国の承認が得られれば2022年中にも供給するとしました。
 KMバイオロジクスの永里敏秋社長は25日の記者説明会で、「小児向けは国内でも十分に治験ができる。できるだけ早く承認をとりたい」と話しました。
 国内ですでに利用されているアメリカのファイザー製とアメリカのモデルナ製、イギリスのアストラゼネカ製の3種類のワクチンは、12歳未満を接種の対象としていません。12歳未満でも接種できるようになれば、同居する家族の感染リスク低減にもつながるとみられます。
 KMバイオロジクスが開発するコロナワクチンは、「不活化ワクチン」というタイプ。弱毒化したウイルスを用いる手法でインフルエンザ予防などでも利用されており、乳幼児なども接種しています。子供向けワクチンの実用化の時期は現状では未定としています。
 同日、18歳以上向けのワクチンについて、「早ければ2022年中の供給を目指す」と明らかにしました。同社によれば、2022年夏ごろに承認申請し、早ければ2022年末から供給を始める計画。厚生労働省が安全性を確認して条件付きで早期承認するなど、一定の条件を満たしたケースを想定しています。
 まずは追加接種(ブースター接種)での実用化を目指す方針で、2021年中にもファイザー製やモデルナ製のメッセンジャーRNA(mRNA)ワクチン、アストラゼネカ製のウイルスベクターワクチンをすでに2回打った人を対象に治験を始める見通し。
 22日には、早期の供給に向けて、治験を中期段階に進めると発表しました。18歳以上の健康な成人2000人を対象とし、2回接種した際の有効性や安全性を調べるとしています。国内で実施し、初回から27日の間隔を空けて2回目を接種して免疫の状態などを調べます。
 すでに実用化されたワクチンとの比較試験も、2022年からアジアなど海外で実施する計画です。製造体制も整備中で、2022年3月末までに年1500万回分の生産を目指します。

 2021年10月25日(月)




nice!(2)  コメント(3) 
共通テーマ:健康

nice! 2

コメント 3

Leeisolf

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by Leeisolf (2021-10-26 21:08) 

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by CharleswaX (2021-11-08 06:10) 

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