Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study,The BMJ

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Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study
The BMJ ( IF 93.6 ) Pub Date : 2021-08-20 , DOI: 10.1136/bmj.n1943
Hannah Chung ₁ , Siyi He ₁ , Sharifa Nasreen ₁ , Maria E Sundaram _{1,

2} , Sarah A Buchan _{1,

2,

3,

4} , Sarah E Wilson _{1,

2,

3,

4} , Branson Chen ₁ , Andrew Calzavara ₁ , Deshayne B Fell _{1,

5,

6} , Peter C Austin _{1,

7} , Kumanan Wilson _{5,

8,

9} , Kevin L Schwartz _{1,

2,

3} , Kevin A Brown _{1,

2,

3} , Jonathan B Gubbay _{3,

10} , Nicole E Basta ₁₁ , Salaheddin M Mahmud ₁₂ , Christiaan H Righolt ₁₂ , Lawrence W Svenson _{13,

14,

15,

16} , Shannon E MacDonald _{15,

17} , Naveed Z Janjua _{18,

19} , Mina Tadrous _{1,

20,

21} , Jeffrey C Kwong _{2,

3,

4,

22,

23,

24} ,

Affiliation

ICES, Toronto, ON, Canada.
Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Public Health Ontario, ON, Canada.
Centre for Vaccine Preventable Diseases, University of Toronto, Toronto, ON, Canada.
School of Epidemiology and Public Health, University of Ottawa, ON, Canada.
Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada.
Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.
Bruyère and Ottawa Hospital Research Institutes, Ottawa, ON, Canada.
Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Department of Epidemiology, Biostatistics, and Occupational Health, School of Population and Global Health, McGill University, Montreal, QC, Canada.
Vaccine and Drug Evaluation Centre, Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada.
Analytics and Performance Reporting Branch, Alberta Health, Edmonton, AB, Canada.
Division of Preventive Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
School of Public Health, University of Alberta, Edmonton, AB, Canada.
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.
British Columbia Centre for Disease Control, Vancouver, BC, Canada.
School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
Women's College Hospital, Toronto, ON, Canada.
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
ICES, Toronto, ON, Canada
Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.
University Health Network, Toronto, ON, Canada.

Objective To estimate the effectiveness of mRNA covid-19 vaccines against symptomatic infection and severe outcomes (hospital admission or death). Design Test negative design study. Setting Ontario, Canada between 14 December 2020 and 19 April 2021. Participants 324 033 community dwelling people aged ≥16 years who had symptoms of covid-19 and were tested for SARS-CoV-2. Interventions BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine. Main outcome measures Laboratory confirmed SARS-CoV-2 by reverse transcription polymerase chain reaction (RT-PCR) and hospital admissions and deaths associated with SARS-CoV-2 infection. Multivariable logistic regression was adjusted for personal and clinical characteristics associated with SARS-CoV-2 and vaccine receipt to estimate vaccine effectiveness against symptomatic infection and severe outcomes. Results Of 324 033 people with symptoms, 53 270 (16.4%) were positive for SARS-CoV-2 and 21 272 (6.6%) received at least one dose of vaccine. Among participants who tested positive, 2479 (4.7%) were admitted to hospital or died. Vaccine effectiveness against symptomatic infection observed ≥14 days after one dose was 60% (95% confidence interval 57% to 64%), increasing from 48% (41% to 54%) at 14-20 days after one dose to 71% (63% to 78%) at 35-41 days. Vaccine effectiveness observed ≥7 days after two doses was 91% (89% to 93%). Vaccine effectiveness against hospital admission or death observed ≥14 days after one dose was 70% (60% to 77%), increasing from 62% (44% to 75%) at 14-20 days to 91% (73% to 97%) at ≥35 days, whereas vaccine effectiveness observed ≥7 days after two doses was 98% (88% to 100%). For adults aged ≥70 years, vaccine effectiveness estimates were observed to be lower for intervals shortly after one dose but were comparable to those for younger people for all intervals after 28 days. After two doses, high vaccine effectiveness was observed against variants with the E484K mutation. Conclusions Two doses of mRNA covid-19 vaccines were observed to be highly effective against symptomatic infection and severe outcomes. Vaccine effectiveness of one dose was observed to be lower, particularly for older adults shortly after the first dose. The study dataset is held securely in coded form at ICES. While legal data sharing agreements between ICES and data providers (eg, healthcare organisations and government) prohibit ICES from making the dataset publicly available, access might be granted to those who meet prespecified criteria for confidential access, available at [www.ices.on.ca/DAS][1] (email das@ices.on.ca). The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the computer programs might rely upon coding templates or macros that are unique to ICES and are therefore either inaccessible or require modification. [1]: http://www.ices.on.ca/DAS

中文翻译：

BNT162b2 和 mRNA-1273 covid-19 疫苗在加拿大安大略省针对症状性 SARS-CoV-2 感染和严重 covid-19 结果的有效性：测试阴性设计研究

目的评估 mRNA covid-19 疫苗对抗症状感染和严重后果（入院或死亡）的有效性。设计测试负面设计研究。时间设定在加拿大安大略省，时间为 2020 年 12 月 14 日至 2021 年 4 月 19 日。参与者为 324 033 名年龄≥16 岁的社区居民，他们有 covid-19 症状，并接受了 SARS-CoV-2 检测。干预措施 BNT162b2 (Pfizer-BioNTech) 或 mRNA-1273 (Moderna) 疫苗。主要结果指标实验室通过逆转录聚合酶链反应 (RT-PCR) 确认了 SARS-CoV-2，以及与 SARS-CoV-2 感染相关的住院和死亡情况。根据与 SARS-CoV-2 和疫苗接种相关的个人和临床特征对多变量逻辑回归进行调整，以估计疫苗针对症状感染和严重后果的有效性。结果在 324 033 名出现症状的人中，53 270 人 (16.4%) 呈 SARS-CoV-2 阳性，21 272 人 (6.6%) 至少接种了一剂疫苗。在检测结果呈阳性的参与者中，有 2479 人（4.7%）入院或死亡。接种一剂后 ≥14 天观察到的疫苗对抗症状感染的有效性为 60%（95% 置信区间 57% 至 64%），从一剂后 14-20 天时的 48%（41% 至 54%）增加至 71%（ 63% 至 78%）在 35-41 天。两次接种后 ≥7 天观察到的疫苗有效性为 91%（89% 至 93%）。接种一剂后 ≥14 天观察到的疫苗对入院或死亡的有效性为 70%（60% 至 77%），从 14-20 天时的 62%（44% 至 75%）增加至 91%（73% 至 97%））在≥35天时观察到，而在两次接种后≥7天观察到的疫苗有效性为98％（88％至100％）。对于年龄≥70 岁的成年人，观察到接种一剂后不久的疫苗有效性估计值较低，但 28 天后所有间隔的疫苗有效性估计值与年轻人相当。接种两次疫苗后，观察到针对具有 E484K 突变的变体的高疫苗有效性。结论观察到两剂 mRNA covid-19 疫苗对症状感染和严重后果非常有效。据观察，一剂疫苗的有效性较低，特别是对于第一剂后不久的老年人。研究数据集以编码形式安全地保存在 ICES 中。虽然 ICES 和数据提供商（例如医疗保健组织和政府）之间的合法数据共享协议禁止 ICES 公开提供数据集，但可以向符合预先指定的保密访问标准的人员授予访问权限，该标准可在 [www.ices.on. ca/DAS][1]（电子邮件 das@ices.on.ca）。作者可根据要求提供完整的数据集创建计划和底层分析代码，并理解计算机程序可能依赖于 ICES 特有的编码模板或宏，因此无法访问或需要修改。 [1]：http://www.ices.on。钙/DAS

更新日期：2021-08-20

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