6カ月～5歳の小児におけるModerna社製およびPfizer社-BioNTech社製のCOVID-19ワクチン使用に関するAdvisory Committee on Immunization Practicesの暫定推奨 ― アメリカ、2022年6月

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ホーム IMICライブラリ MMWR抄訳 2022年（Vol.71)6カ月～5歳の小児におけるModerna社製および･･･

MMWR抄訳

2022/07/01Vol. 71 / No. 26

MMWR71(26):859－868
Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months–5 Years — United States, June 2022

6カ月～5歳の小児におけるModerna社製およびPfizer社-BioNTech社製のCOVID-19ワクチン使用に関するAdvisory Committee on Immunization Practicesの暫定推奨 ― アメリカ、2022年6月

2022年6月17日、FDAは生後6カ月～5歳の小児に対するmRNA-1273(Moderna社製)COVID-19ワクチンの緊急使用許可の修正を発表し、投与方法を2回[各回25µg(0.25mL)]、接種間隔は4週間とした。また、生後6カ月～4歳児に対するBNT162b2(Pfizer社-BioNTech社製)COVID-19ワクチンの使用は3回[各回3µg(0.2mL)]、1回目と2回目の接種間隔は3週間、2回目と3回目の接種間隔は8週間以上とした。6月18日、Advisory Committee on Immunization Practices(ACIP)はCOVID-19予防として、生後6カ月～5歳児に対するModerna社製ワクチン、生後6カ月～4歳児に対するPfizer社-BioNTech社製ワクチンの使用に関する推奨をそれぞれ発表した。Moderna社製COVID-19ワクチンは第Ⅱ/Ⅲ相二重盲検プラセボ対照比較試験にて、対象の生後6カ月～5歳児6,388名がワクチン(25µg)群またはプラセボ(生理食塩水)群に3：1の割合で無作為に割り付けられ、それぞれ28日間の間隔をあけて2回接種された。2回接種後14日以降のワクチンの効力は37.8％と報告された。COVID-19の原因ウイルスであるSARS-CoV-2感染の既往がない生後6カ月～23カ月および2～5歳児に対するModerna社製COVID-19ワクチン2回接種(各回25µg)の免疫反応は、少なくとも18～25歳の若年成人に対する同ワクチン2回接種(各回100µg)後に認められた反応と同等であり、50％中和抗体価の幾何平均比(GMR)は生後6～23カ月齢で1.28、2～5歳では1.01といずれも非劣性基準を満たした。Pfizer社-BioNTech社製COVID-19ワクチンは第Ⅱ/Ⅲ相二重盲検無作為化プラセボ対照比較試験にて、対象の生後6カ月～4歳児4,526名がワクチン(3µg)またはプラセボ(生理食塩水)群に2：1の割合で無作為に割り付けられ、3週間の間隔でそれぞれ2回接種し、2022年2月1日のプロトコル修正により2回目接種の56日後以降に3回目接種が行われ、1,456名(ワクチン群992名、プラセボ群464名)が接種した。3回接種後7日以降のワクチンの効力は80.0％であった。immunobridging分析では、SARS-CoV-2感染の既往がない生後6カ月～4歳児に対するPfizer社-BioNTech社製COVID-19ワクチン3回接種(各回3µg)の免疫反応は、少なくとも16～25歳の人に対する同ワクチン2回接種(各回30µg)後に認められた反応と同等であり、50％中和抗体価のGMRは生後6～23カ月齢にて1.19、2～4歳にて1.30といずれも非劣性基準を満たした。Grading of Recommendations, Assessment, Development and Evaluation(GRADE)アプローチによるエビデンス評価では、COVID-19予防の直接的効果による評価に関して、Moderna社製ワクチンはタイプ1(高い確実性)、Pfizer社-BioNTech社製ワクチンはタイプ4(非常に低い確実性)、免疫ブリッジングによる評価ではともにタイプ2(中程度の確実性)とされた。Evidence to Recommendation(EtR)フレームワークのデータ調査では、生後6カ月～5歳児に対するCOVID-19ワクチンの使用は支持され、ACIPはCOVID-19ワクチン接種の有益性は潜在的なリスクを上回ると判断し、生後6カ月～5歳児に対するModerna社製COVID-19ワクチンのプライマリ2回接種、生後6カ月～4歳児に対するPfizer社-BioNTech社製COVID-19ワクチンのプライマリ3回接種を暫定的に推奨した。2022年6月12日時点で、アメリカでは生後6カ月～4歳児にて約200万人の感染、2万人の入院、200人のCOVID-19による死亡が報告されている。ワクチン接種は生後6カ月～5歳児をCOVID-19から防護するために重要である。

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