COVID-19 Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection During Delta-Dominant and Omicron-Dominant Periods in Japan: A Multicenter Prospective Case-control Study (Factors Associated with SARS-CoV-2 Infection and the Effectiveness of COVID-19 Vaccines Study)

被引：57

作者：

Arashiro, Takeshi ^{[1
,2
,3
,4
]}

Arima, Yuzo ^{[1
]}

Muraoka, Hirokazu ^{[5
]}

Sato, Akihiro ^{[6
]}

Oba, Kunihiro ^{[7
]}

Uehara, Yuki ^{[8
]}

Arioka, Hiroko ^{[9
]}

Yanai, Hideki ^{[10
]}

Kuramochi, Jin ^{[11
]}

Ihara, Genei ^{[12
]}

Chubachi, Kumi ^{[13
]}

Yanagisawa, Naoki ^{[14
]}

Nagura, Yoshito ^{[15
]}

Kato, Yasuyuki ^{[16
]}

Ueda, Akihiro ^{[17
]}

Numata, Akira ^{[18
]}

Kato, Hideaki ^{[19
]}

Ishii, Koji ^{[20
]}

Ooki, Takao ^{[20
]}

Oka, Hideaki ^{[21
]}

Nishida, Yusuke ^{[21
]}

Stucky, Ashley ^{[1
]}

Smith, Chris ^{[3
,4
]}

Hibberd, Martin ^{[3
]}

Ariyoshi, Koya ^{[4
]}

Suzuki, Motoi ^{[1
]}

机构：

[1] Natl Inst Infect Dis, Ctr Surveillance Immunizat & Epidemiol Res, Tokyo, Japan

[2] Natl Inst Infect Dis, Dept Pathol, Tokyo, Japan

[3] London Sch Hyg & Trop Med, Fac Infect & Trop Dis, London, England

[4] Nagasaki Univ, Sch Trop Med & Global Hlth, Nagasaki, Japan

[5] Clin Tamachi, Tokyo, Japan

[6] KARADA Internal Med Clin, Tokyo, Japan

[7] Showa Gen Hosp, Dept Pediat, Tokyo, Japan

[8] St Lukes Int Hosp, Dept Clin Lab, Tokyo, Japan

[9] St Lukes Int Hosp, Dept Gen Internal Med, Tokyo, Japan

[10] Japan AntiTB Assoc, Fukujuji Hosp, Kiyose, Japan

[11] Kuramochi Clin, Interpk, Utsunomiya, Tochigi, Japan

[12] Machida Ekimae Naika Clin, Tokyo, Japan

[13] Chubachi Internal Resp Med Clin, Tokyo, Japan

[14] Yanagisawa Clin, Tokyo, Japan

[15] Shinjuku Home Clin, Tokyo, Japan

[16] Int Univ Hlth & Welf, Dept Infect Dis, Narita Hosp, Chiba, Japan

[17] Japanese Red Cross Med Ctr, Dept Infect Dis, Tokyo, Japan

[18] Ikebukuro Metropolitan Clin, Tokyo, Japan

[19] Yokohama City Univ Med, Infect Prevent & Control Dept, Yokohama, Kanagawa, Japan

[20] Saitama Sekishinkai Hosp, Saitama, Japan

[21] Saitama Med Ctr, Dept Gen Internal Med & Infect Dis, Saitama, Japan

来源：

CLINICAL INFECTIOUS DISEASES | 2023年 / 76卷 / 03期

关键词：

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); coronavirus disease 2019 (COVID-19); test-negative design; vaccine effectiveness; SARS-CoV-2; variants; BNT162B2; STATES;

D O I：

10.1093/cid/ciac635

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background Although several coronavirus disease 2019 (COVID-19) vaccines initially showed high efficacy, there have been concerns because of waning immunity and the emergence of variants with immune escape capacity. Methods A test-negative design case-control study was conducted in 16 healthcare facilities in Japan during the Delta-dominant period (August-September 2021) and the Omicron-dominant period (January-March 2022). Vaccine effectiveness (VE) against symptomatic severe acute respiratory syndrome coronavirus 2 infection was calculated for 2 doses for the Delta-dominant period and 2 or 3 doses for the Omicron-dominant period compared with unvaccinated individuals. Results The analysis included 5795 individuals with 2595 (44.8%) cases. Among vaccinees, 2242 (55.8%) received BNT162b2 and 1624 (40.4%) received messenger RNA (mRNA)-1273 at manufacturer-recommended intervals. During the Delta-dominant period, VE was 88% (95% confidence interval [CI], 82-93) 14 days to 3 months after dose 2 and 87% (95% CI, 38-97) 3 to 6 months after dose 2. During the Omicron-dominant period, VE was 56% (95% CI, 37-70) 14 days to 3 months since dose 2, 52% (95% CI, 40-62) 3 to 6 months after dose 2, 49% (95% CI, 34-61) 6+ months after dose 2, and 74% (95% CI, 62-83) 14+ days after dose 3. Restricting to individuals at high risk of severe COVID-19 and additional adjustment for preventive measures (ie, mask wearing/high-risk behaviors) yielded similar estimates, respectively. Conclusions In Japan, where most are infection-naive, and strict prevention measures are maintained regardless of vaccination status, 2-dose mRNA vaccines provided high protection against symptomatic infection during the Delta-dominant period and moderate protection during the Omicron-dominant period. Among individuals who received an mRNA booster dose, VE recovered to a high level. In this test-negative case-control study in Japan, 2-dose messenger RNA (mRNA) coronavirus disease 2019 vaccines provided high and moderate protection against symptomatic infection during the Delta- and Omicron-dominant period, respectively. Among mRNA booster recipients, vaccine effectiveness recovered to a high level in the short-term.

引用

页码：E108 / E115

页数：8

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