da Fonseca Elize M, Jarman Holly, King Elizabeth J, Greer Scott L
Sao Paulo School of Business Administration Getulio Vargas Foundation Sao Paulo Brazil.
Latin America and Caribbean Centre London School of Economics London UK.
Regul Gov. 2021 May 24. doi: 10.1111/rego.12413.
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.
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。