mRNA vaccine development during the COVID-19 pandemic: a retrospective review from the perspective of the Swiss affiliate of a global biopharmaceutical company.

COVID - 19 大流行期间的 mRNA 疫苗开发 ： 从全球生物制药公司瑞士子公司的角度进行的回顾性回顾。

• 发表时间: 2023 Nov 27
• 来源期刊: J Pharm Policy Pract
• DOI: 10.1186/s40545-023-00652-y
• PMID: 38012751
• 文章类型: Journal Article
• 作者列表: Killeen T,Kermer V,Troxler Saxer R

关键词: Clinical development; Coronavirus disease 2019; Messenger ribonucleic acid; Pandemic; Public health; Regulatory; Safety; Supply; Switzerland; Vaccines

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has been the defining public health emergency of our time. In Switzerland, messenger RNA (mRNA) vaccines were and still are widely utilized as a critical component of the Federal Office of Public Health (FOPH)\'s preventative mitigation strategy. The development, conditional approval and worldwide roll-out of mRNA vaccines against COVID-19 proceeded at an unprecedented pace and presented myriad challenges for manufacturers. In this review, we discuss, from the perspective of the Swiss affiliate of a global biopharmaceutical company, the clinical, regulatory, pharmacovigilance and logistical considerations of making a mRNA COVID-19 vaccine available to the Swiss population during a pandemic as rapidly as possible while ensuring strict adherence to safety and quality standards.

摘要

2019年冠状病毒病(COVID-19)大流行一直是我们这个时代决定性的突发公共卫生事件。在瑞士,信使RNA（mRNA）疫苗曾经并且仍然被广泛用作联邦公共卫生办公室（FOPH）的预防性缓解策略的关键组成部分。的发展,COVID-19mRNA疫苗的有条件批准和全球推广以前所未有的速度进行，给制造商带来了无数挑战。在这次审查中,我们讨论,从一家全球生物制药公司的瑞士子公司的角度来看，临床，监管,在大流行期间尽快向瑞士人群提供mRNACOVID-19疫苗的药物警戒和后勤考虑，同时确保严格遵守安全和质量标准。