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06【参考資料１】新型コロナワクチンに関する資料 (81 ページ)
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| 出典情報 | 厚生科学審議会 予防接種・ワクチン分科会（第44回 2／22）《厚生労働省》 |
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Open 5, e2237140 (2022). https://doi.org:10.1001/jamanetworkopen.2022.37140
51
Kurhade, C. et al. Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1, and
XBB.1 by parental mRNA vaccine or a BA.5-bivalent booster. Nat Med (2022).
https://doi.org:10.1038/s41591-022-02162-x
52
新城雄士ら. 新型コロナワクチンの有効性を検討した症例対照研究の暫定報告（第五
報）：オミクロン対応 2 価ワクチンの有効性 , <https://www.niid.go.jp/niid/ja/2019ncov/2484-idsc/11688-covid19-9999.html> (2022).
53
Link-Gelles, R. et al. Effectiveness of Bivalent mRNA Vaccines in Preventing
Symptomatic SARS-CoV-2 Infection - Increasing Community Access to Testing Program,
United States, September-November 2022. MMWR Morb Mortal Wkly Rep 71, 15261530 (2022). https://doi.org:10.15585/mmwr.mm7148e1
54
UKHSA. COVID-19 vaccine surveillance report Week 2. (2023).
55
Agency, U. H. S. COVID-19 vaccine surveillance report Week 48. (2022).
56
Hause, A. M. et al. Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster
Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022.
MMWR
Morb
Mortal
Wkly
Rep
71,
1401-1406
(2022).
https://doi.org:10.15585/mmwr.mm7144a3
57
独立行政法人医薬品医療機器総合機構. 特例承認に係る報告書（コミナティ RTU 筋注
_
フ
ァ
イ
ザ
ー
株
式
会
社
）
,
<https://www.pmda.go.jp/drugs/2022/P20220912001/672212000_30400AMX00016_
A100_1.pdf> (2022).
58
FDA.
FACT SHEET_PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
(ORIGINAL AND OMICRON BA.4/BA.5) BOOSTER DOSE FOR 12 YEARS OF AGE
AND OLDER, <https://www.fda.gov/media/161327/download> (
59
Jing Zou, C. K., Sohil Patel, Nicholas Kitchin, Kristin Tompkins, Mark Cutler, David
Cooper, Qi Yang, Hui Cai, Alexander Muik, Ying Zhang, Dung-Yang Lee, Ugur Sahin,
Annaliesa S. Anderson, William C. Gruber, Xuping Xie1, Kena A. Swanson, Pei Yong Shi.
(Preprint) Improved Neutralization of Omicron BA.4/5, BA.4.6, BA.2.75.2, BQ.1.1, and
XBB.1 with Bivalent BA.4/5 Vaccine. bioRxiv (2022).
60
Ronen Arbel, A. P., Ruslan Sergienko, Michael Friger, Tanya Beckenstein, Shlomit Yaron,
Ariel Hammerman, Natalya Bilenko, Doron Netzer. Effectiveness of the Bivalent mRNA
Vaccine in Preventing Severe COVID-19 Outcomes: An Observational Cohort Study.
Preprint.
61
(2023).
Chalkias, S. et al. A Bivalent Omicron-Containing Booster Vaccine against Covid-19. N
Engl J Med 387, 1279-1291 (2022). https://doi.org:10.1056/NEJMoa2208343
62
Chalkias, S. et al. Safety and Immunogenicity of Omicron BA.4/BA.5 Bivalent Vaccine
81
51
Kurhade, C. et al. Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1, and
XBB.1 by parental mRNA vaccine or a BA.5-bivalent booster. Nat Med (2022).
https://doi.org:10.1038/s41591-022-02162-x
52
新城雄士ら. 新型コロナワクチンの有効性を検討した症例対照研究の暫定報告（第五
報）：オミクロン対応 2 価ワクチンの有効性 , <https://www.niid.go.jp/niid/ja/2019ncov/2484-idsc/11688-covid19-9999.html> (2022).
53
Link-Gelles, R. et al. Effectiveness of Bivalent mRNA Vaccines in Preventing
Symptomatic SARS-CoV-2 Infection - Increasing Community Access to Testing Program,
United States, September-November 2022. MMWR Morb Mortal Wkly Rep 71, 15261530 (2022). https://doi.org:10.15585/mmwr.mm7148e1
54
UKHSA. COVID-19 vaccine surveillance report Week 2. (2023).
55
Agency, U. H. S. COVID-19 vaccine surveillance report Week 48. (2022).
56
Hause, A. M. et al. Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster
Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022.
MMWR
Morb
Mortal
Wkly
Rep
71,
1401-1406
(2022).
https://doi.org:10.15585/mmwr.mm7144a3
57
独立行政法人医薬品医療機器総合機構. 特例承認に係る報告書（コミナティ RTU 筋注
_
フ
ァ
イ
ザ
ー
株
式
会
社
）
,
<https://www.pmda.go.jp/drugs/2022/P20220912001/672212000_30400AMX00016_
A100_1.pdf> (2022).
58
FDA.
FACT SHEET_PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
(ORIGINAL AND OMICRON BA.4/BA.5) BOOSTER DOSE FOR 12 YEARS OF AGE
AND OLDER, <https://www.fda.gov/media/161327/download> (
59
Jing Zou, C. K., Sohil Patel, Nicholas Kitchin, Kristin Tompkins, Mark Cutler, David
Cooper, Qi Yang, Hui Cai, Alexander Muik, Ying Zhang, Dung-Yang Lee, Ugur Sahin,
Annaliesa S. Anderson, William C. Gruber, Xuping Xie1, Kena A. Swanson, Pei Yong Shi.
(Preprint) Improved Neutralization of Omicron BA.4/5, BA.4.6, BA.2.75.2, BQ.1.1, and
XBB.1 with Bivalent BA.4/5 Vaccine. bioRxiv (2022).
60
Ronen Arbel, A. P., Ruslan Sergienko, Michael Friger, Tanya Beckenstein, Shlomit Yaron,
Ariel Hammerman, Natalya Bilenko, Doron Netzer. Effectiveness of the Bivalent mRNA
Vaccine in Preventing Severe COVID-19 Outcomes: An Observational Cohort Study.
Preprint.
61
(2023).
Chalkias, S. et al. A Bivalent Omicron-Containing Booster Vaccine against Covid-19. N
Engl J Med 387, 1279-1291 (2022). https://doi.org:10.1056/NEJMoa2208343
62
Chalkias, S. et al. Safety and Immunogenicity of Omicron BA.4/BA.5 Bivalent Vaccine
81