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Arch Public Health. 2022 Jul 18;80(1):171. doi: 10.1186/s13690-022-00924-0.

本文引用的文献

1
Arab nations first to approve Chinese COVID vaccine - despite lack of public data.阿拉伯国家率先批准中国新冠疫苗——尽管缺乏公开数据。
Nature. 2020 Dec;588(7839):548. doi: 10.1038/d41586-020-03563-z.
2
The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials.赋予 COVID-19 候选疫苗紧急使用授权:对 COVID-19 疫苗试验的影响。
Lancet Infect Dis. 2021 Apr;21(4):e103-e109. doi: 10.1016/S1473-3099(20)30923-3. Epub 2020 Dec 8.
3
Conflicts of interest among the UK government's covid-19 advisers.英国政府新冠疫情顾问之间的利益冲突。
BMJ. 2020 Dec 9;371:m4716. doi: 10.1136/bmj.m4716.
4
The UK Government's Vaccine Taskforce: strategy for protecting the UK and the world.英国政府疫苗特别工作组:保护英国及全球的战略。
Lancet. 2021 Jan 2;397(10268):68-70. doi: 10.1016/S0140-6736(20)32175-9. Epub 2020 Oct 27.
5
Navigating facilitated regulatory pathways during a disease X pandemic.在X疾病大流行期间应对便利的监管途径。
NPJ Vaccines. 2020 Oct 23;5:101. doi: 10.1038/s41541-020-00249-5. eCollection 2020.
6
COVID-19 vaccines: time to talk about the uncertainties.新冠疫苗:是时候谈谈不确定性了。
Nature. 2020 Oct;586(7830):475. doi: 10.1038/d41586-020-02944-8.
7
The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage.世界卫生组织全球基准工具:加强医疗产品监管和促进全民健康覆盖的工具
Front Med (Lausanne). 2020 Aug 19;7:457. doi: 10.3389/fmed.2020.00457. eCollection 2020.
8
The Russian vaccine for COVID-19.俄罗斯的新冠疫苗。
Lancet Respir Med. 2020 Nov;8(11):e85-e86. doi: 10.1016/S2213-2600(20)30402-1. Epub 2020 Sep 5.
9
COVID-19 vaccine trials should seek worthwhile efficacy.新冠病毒疫苗试验应追求有价值的疗效。
Lancet. 2020 Sep 12;396(10253):741-743. doi: 10.1016/S0140-6736(20)31821-3. Epub 2020 Aug 27.
10
Scientific Advice at a Time of Emergency. SAGE and Covid-19.紧急时刻的科学建议。SAGE与新冠疫情。
Polit Q. 2020 Jul-Sep;91(3):514-522. doi: 10.1111/1467-923X.12885. Epub 2020 Aug 1.

新冠疫苗监管的政治经济学研究视角

Perspectives in the study of the political economy of COVID-19 vaccine regulation.

作者信息

da Fonseca Elize M, Jarman Holly, King Elizabeth J, Greer Scott L

机构信息

Sao Paulo School of Business Administration Getulio Vargas Foundation Sao Paulo Brazil.

Latin America and Caribbean Centre London School of Economics London UK.

出版信息

Regul Gov. 2021 May 24. doi: 10.1111/rego.12413.

DOI:10.1111/rego.12413
PMID:34226834
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8242737/
Abstract

Vaccines against SARS-CoV-2 continue to be developed at an astonishingly quick speed and the early ones, like Pfizer and Moderna, have been shown to be more effective than many public health scientists had dared to hope. As COVID-19 vaccine research continues to progress, the world's eyes are turning toward medicine regulators. COVID-19 vaccines need to be authorized for use in each country in which the pharmaceutical industry intends to commercialize its product. This results in a patchwork of regulations that can influence the speed at which products are launched and the standards that govern them. In this research forum article, we discuss several key questions about COVID-19 vaccine regulations that should shape research on the next stage of the pandemic response. We call for a research agenda that looks into the political economy of pharmaceutical regulation, particularly from a comparative perspective, including Global South countries.

摘要

针对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的疫苗仍在以惊人的速度研发,早期的疫苗,如辉瑞和莫德纳的疫苗,已被证明比许多公共卫生科学家敢期望的更有效。随着2019冠状病毒病(COVID-19)疫苗研究的不断推进,全世界的目光都转向了药品监管机构。COVID-19疫苗需要在制药行业打算将其产品商业化的每个国家获得使用授权。这导致了一套参差不齐的法规,可能会影响产品推出的速度以及管理这些产品的标准。在这篇研究论坛文章中,我们讨论了几个关于COVID-19疫苗法规的关键问题,这些问题应该会影响大流行应对下一阶段的研究。我们呼吁制定一项研究议程,研究药品监管的政治经济学,特别是从比较的角度,包括全球南方国家。