ホームIMICライブラリMMWR抄訳2022年(Vol.71)18歳以上の成人におけるModerna社製COVI・・・
MMWR抄訳
2022/03/18Vol. 71 / No. 11
MMWR71(11):416-421
The Advisory Committee on Immunization Practices’ Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines — United States, February 2022
18歳以上の成人におけるModerna社製COVID-19ワクチンの使用に関するAdvisory Committee on Immunization Practicesの推奨とmRNA COVID-19ワクチンのプライマリーシリーズ接種の間隔延長に関する検討 ― アメリカ、2022年2月
mRNA-1273(Moderna社製)COVID-19ワクチンは、脂質ナノ粒子に封入したヌクレオシド修飾mRNAワクチンで、COVID-19の原因ウイルスであるSARS-CoV-2の融合前構造に安定化されたスパイクタンパク質をコードしている。2020年12月に、このワクチンはFDAから緊急使用許可を認められ、Advisory Committee on Immunization Practices(ACIP)は18歳以上の人に対する使用の暫定推奨を発表し、CDCにより採択された。2020年12月19日~2022年1月30日に、アメリカでは約2億400万回のModerna社製COVID-19ワクチンが、4週間間隔で2回の筋肉内投与[各回100μg(0.5mL)]のプライマリーシリーズとして接種された。2022年1月31日に、FDAは18歳以上の人に対するModerna社製COVID-19ワクチン(Spikevax)の使用に関する生物製剤承認申請を承認した。2022年2月4日に、Moderna社製COVID-19ワクチンの使用に関する推奨についてのACIP COVID-19ワクチンワークグループの結論は、公開会議でACIPに提示された。ワークグループの審議は、エビデンスの質をランク付けするためのGrading of Recommendations, Assessment, Development and Evaluationアプローチを組み込んだEvidence to Recommendation Frameworkに基づいた。ACIPは、初期の臨床試験データに加えて、臨床試験での追加の経過期間、実臨床でのワクチン有効性研究、ワクチンの承認後安全性モニタリングを含む暫定推奨の発行から12カ月間に収集された新規の情報について検討し、臨床試験で使用されたオリジナルの間隔[BNT162b2(Pfizer社-BioNTech社製)COVID-19ワクチンは3週間、Moderna社製COVID-19ワクチンは4週間]に代わり、最初の接種から8週間あけて接種した場合の実臨床でのmRNAワクチンの有効性と安全性の比較も検討した。このエビデンスに基づいて、CDCは、8週間の間隔が一部の思春期齢および成人、特に12~39歳の男性に最適である可能性があるというガイダンスを提供した。暫定推奨の発行以降に収集された追加情報により、Moderna社製COVID-19ワクチンの症候性および無症候性のSARS-CoV-2感染、入院、死亡を予防する有益性は、ワクチン関連リスクを上回るという確実性が高まった。2022年2月4日に、ACIPは暫定推奨を、18歳以上の人に対し完全に承認されたModerna社製COVID-19ワクチン使用に関する標準推奨に変更した。
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