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Hum Vaccin Immunother. 2022 Nov 30;18(5):2064134. doi: 10.1080/21645515.2022.2064134. Epub 2022 Apr 22.

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Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial.一种灭活严重急性呼吸综合征冠状病毒2疫苗(科兴新冠疫苗)在60岁及以上健康成年人中的安全性、耐受性和免疫原性:一项随机、双盲、安慰剂对照的1/2期临床试验
Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.
2
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.BNT162b2 mRNA 新冠病毒疫苗的安全性和有效性。
N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
3
Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial.在年轻和老年成年人中进行的一次单盲、随机、对照、2/3 期试验中,观察 ChAdOx1 nCoV-19 疫苗在初免-加强免疫方案中的安全性和免疫原性(COV002)。
Lancet. 2021 Dec 19;396(10267):1979-1993. doi: 10.1016/S0140-6736(20)32466-1. Epub 2020 Nov 19.
4
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial.一项在 18-59 岁健康成年人中进行的新型冠状病毒灭活疫苗的安全性、耐受性和免疫原性的随机、双盲、安慰剂对照、1/2 期临床试验。
Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.
5
The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI).布莱顿协作组织:满足免疫接种后不良事件(AEFI)标准化病例定义的需求。
Vaccine. 2002 Dec 13;21(3-4):298-302. doi: 10.1016/s0264-410x(02)00449-8.

Inconsistent Safety Outcome Reporting in Randomized Clinical Trials of COVID-19 Vaccines Complicates Informed Medical Decisions.

作者信息

Blais Joseph E, Wei Yue, Chui Celine S L, Chan Esther W, Wong Ian C K

机构信息

Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, General Office, L02-56 2/F Laboratory Block, 21 Sassoon Road, Pokfulam, Hong Kong SAR, China.

School of Nursing, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China.

出版信息

Drug Saf. 2021 Nov;44(11):1121-1123. doi: 10.1007/s40264-021-01108-5. Epub 2021 Aug 17.

DOI:10.1007/s40264-021-01108-5
PMID:34405364
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8370447/
Abstract
摘要