The Canadian National Vaccine Safety Network: surveillance of adverse events following immunisation among individuals immunised with the COVID-19 vaccine, a cohort study in Canada.
The Canadian National Vaccine Safety Network: surveillance of adverse events following immunisation among individuals immunised with the COVID-19 vaccine, a cohort study in Canada.
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DOI：
10.1136/bmjopen-2021-051254
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发表时间：
2022-01-20
期刊：
影响因子：
2.9
通讯作者：
Canadian Immunization Research Network
中科院分区：
文献类型：
--
作者：
Bettinger JA;Sadarangani M;De Serres G;Valiquette L;Vanderkooi OG;Kellner JD;Muller MP;Top KA;Isenor JE;McGeer A;Marty K;Canadian Immunization Research Network
COVID-19疫苗在紧急批准后需要加强安全监测。加拿大国家疫苗安全网络监测COVID-19疫苗的安全性，并为健康、自身免疫、免疫功能低下、怀孕和哺乳人群提供加强监测，并允许检测安全信号。在三项调查中收集了12岁及以上接种疫苗和未接种疫苗个体的在线参与者报告的健康事件：第1剂后1周，第2剂后1周和第1剂后7个月。通过电话跟踪医疗护理活动。按健康事件、疫苗类型、性别和10岁年龄组计算数量、百分比、每10000人的发病率和发病率比及其95% CI。每个研究中心都有研究伦理委员会对该项目的批准（UBC儿童与妇女、CIUSSS de l 'Estrie-CHUS、Health PEI、联合健康研究伦理委员会、卡尔加里大学和阿尔伯塔卫生服务、IWK Health、Unity Health多伦多和魁北克大学拉瓦尔研究伦理委员会）。邀请个人参加这种主动监测，并在进行每次调查之前给予电子同意。每周报告与公共卫生部门共享，并张贴在研究网站上。至少编写一份同行评审的手稿。
COVID-19 vaccines require enhanced safety monitoring after emergency approval. The Canadian National Vaccine Safety Network monitors the safety of COVID-19 vaccines and provides enhanced monitoring for healthy, auto-immune, immunocompromised, pregnant and breastfeeding populations and allows for the detection of safety signals. Online participant reporting of health events in vaccinated and unvaccinated individuals 12 years of age and older is captured in three surveys: 1 week after dose 1, 1 week after dose 2 and 7 months after dose 1. Medically attended events are followed up by telephone. The number, percentage, rate per 10 000 and incident rate ratios with 95% CIs are calculated by health event, vaccine type, sex and in 10-year age groups. Each study site has Research Ethics Board approvals for the project (UBC Children’s & Women’s, CIUSSS de l'Estrie—CHUS, Health PEI, Conjoint Health Research Ethics Board, University of Calgary and Alberta Health Services, IWK Health, Unity Health Toronto and CHU de Québec-Université Laval Research Ethics Boards). Individuals are invited to participate in this active surveillance and electronic consent is given before proceeding to each survey. Weekly reports are shared with public health and posted on the study website. At least one peer-reviewed manuscript is produced.
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BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
DOI：
10.1016/s0140-6736(20)32661-1
发表时间：
2021-01-09
期刊：
Lancet (London, England)
影响因子：
--
作者：
Voysey M;Clemens SAC;Madhi SA;Weckx LY;Folegatti PM;Aley PK;Angus B;Baillie VL;Barnabas SL;Bhorat QE;Bibi S;Briner C;Cicconi P;Collins AM;Colin-Jones R;Cutland CL;Darton TC;Dheda K;Duncan CJA;Emary KRW;Ewer KJ;Fairlie L;Faust SN;Feng S;Ferreira DM;Finn A;Goodman AL;Green CM;Green CA;Heath PT;Hill C;Hill H;Hirsch I;Hodgson SHC;Izu A;Jackson S;Jenkin D;Joe CCD;Kerridge S;Koen A;Kwatra G;Lazarus R;Lawrie AM;Lelliott A;Libri V;Lillie PJ;Mallory R;Mendes AVA;Milan EP;Minassian AM;McGregor A;Morrison H;Mujadidi YF;Nana A;O'Reilly PJ;Padayachee SD;Pittella A;Plested E;Pollock KM;Ramasamy MN;Rhead S;Schwarzbold AV;Singh N;Smith A;Song R;Snape MD;Sprinz E;Sutherland RK;Tarrant R;Thomson EC;Török ME;Toshner M;Turner DPJ;Vekemans J;Villafana TL;Watson MEE;Williams CJ;Douglas AD;Hill AVS;Lambe T;Gilbert SC;Pollard AJ;Oxford COVID Vaccine Trial Group
通讯作者：
Oxford COVID Vaccine Trial Group
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group
DOI：
10.1016/s1045-1870(03)00036-0
发表时间：
2003-07-01
期刊：
Seminars in pediatric infectious diseases
影响因子：
--
作者：
Scheifele, David W;Halperin, Scott A
通讯作者：
Halperin, Scott A
影响因子：
8
作者：
Chen, RT;Glasser, JW;Caserta, V
通讯作者：
Caserta, V