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参考資料15 COVID-19 vaccine safety update; Primary series in young children and booster doses in older children and adults, ACIP September 1, 2022 (37 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000208910_00052.html |
| 出典情報 | 第85回厚生科学審議会予防接種・ワクチン分科会副反応検討部会、令和４年度第14回薬事・食品衛生審議会薬事分科会医薬品等安全対策部会安全対策調査会（合同開催）（10／7）《厚生労働省》 |
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Summary: mRNA COVID-19 vaccine safety of booster doses in people
ages 5 years and older
▪ Safety findings are generally consistent with those observed for primary series
vaccination
▪ Evidence suggests an increased risk for myocarditis following 1st booster dose
• Myocarditis is a rare event following mRNA COVID-19 booster vaccination
‒ CDC has verified 131 myocarditis case reports to VAERS in people ages ≥5 years after
123,362,627 million mRNA COVID-19 booster vaccinations
• Risk primarily observed in adolescent and young adult males
• No statistical signal for myocarditis to date in children ages 5–11 years following 1st booster
▪ In VAERS data, reporting rates of myocarditis are lower following 1st booster
dose vs. dose 2 of primary series (and lower following dose 1 vs. dose 2 of primary series)
▪ In VSD analyses, myocarditis/pericarditis incidence following 1st booster dose
and dose 2 of the primary series are similar, though case counts are small and
confidence intervals around point estimates are wide
37
ages 5 years and older
▪ Safety findings are generally consistent with those observed for primary series
vaccination
▪ Evidence suggests an increased risk for myocarditis following 1st booster dose
• Myocarditis is a rare event following mRNA COVID-19 booster vaccination
‒ CDC has verified 131 myocarditis case reports to VAERS in people ages ≥5 years after
123,362,627 million mRNA COVID-19 booster vaccinations
• Risk primarily observed in adolescent and young adult males
• No statistical signal for myocarditis to date in children ages 5–11 years following 1st booster
▪ In VAERS data, reporting rates of myocarditis are lower following 1st booster
dose vs. dose 2 of primary series (and lower following dose 1 vs. dose 2 of primary series)
▪ In VSD analyses, myocarditis/pericarditis incidence following 1st booster dose
and dose 2 of the primary series are similar, though case counts are small and
confidence intervals around point estimates are wide
37