Cole Abimbola, Webster Peggy, Van Liew Denny, Salas Maribel, Aimer Omar, Malikova Marina A
GSK plc, Brentford UK. MCPHS University, Boston, MA, USA.
GSK plc, Brentford, UK.
Ther Adv Drug Saf. 2022 Sep 5;13:20420986221116452. doi: 10.1177/20420986221116452. eCollection 2022.
The COVID-19 pandemic, caused by a novel type of coronavirus, continues to infect people, increasing morbidity and mortality across the globe. Measures to slow the transmission of the virus have had limited impact, and people, businesses, and economies have suffered. The disease has disproportionally impacted elderly and individuals with certain pre-existing conditions and has highlighted health and social inequities in some racial and ethnic minority groups. The majority of those who contract the disease recover completely, but some experience long-lasting complications. Vaccines have the potential to end the pandemic, and through the intense collaboration of scientists in government and private sectors, more than 200 COVID-19 candidate vaccines have been or are being developed, using known platforms and previous experiences with severe acute respiratory syndrome (SARS), at unprecedented speed. The expectations for vaccine safety and quality in the setting of accelerated development are the same as during non-emergency times; however, challenges inherent with the circumstances of the pandemic situation provide opportunities to improve clinical trial conduct and strengthen pharmacovigilance systems. We have reviewed and analyzed existing PV guidelines and recommendations throughout the lifecycle of vaccine development with a focus on developing a global/worldwide effort for post-marketing vaccine safety surveillance.
This is an extensive review that intends to address important aspects of COVID-19 vaccines' accelerated development and safety surveillance. It is focused on regulatory requirements for long-term safety monitoring, practical applications, and current global efforts in developing robust pharmacovigilance systems for post-authorization surveillance.Notably, different perspectives of authors from industry, academic institutions, and contract research organizations involved in drug safety were incorporated to reflect on various regulatory requirements and new developments in vaccine safety. All co-authors are current members of International Society of Pharmacovigilance (ISoP).
由新型冠状病毒引起的COVID-19大流行继续感染人们，在全球范围内增加发病率和死亡率。减缓病毒传播的措施影响有限，人们、企业和经济都受到了影响。该疾病对老年人和某些有基础疾病的个体影响尤为严重，并凸显了一些种族和少数族裔群体中的健康和社会不平等现象。大多数感染该疾病的人会完全康复，但有些人会经历长期并发症。疫苗有潜力终结这一大流行，通过政府和私营部门科学家的紧密合作，利用已知平台以及以往应对严重急性呼吸综合征（SARS）的经验，已经或正在以前所未有的速度研发200多种COVID-19候选疫苗。在加速研发背景下对疫苗安全性和质量的期望与非紧急时期相同；然而，大流行形势带来的固有挑战为改进临床试验实施和加强药物警戒系统提供了机遇。我们审查并分析了疫苗研发全生命周期内现有的药物警戒指南和建议，重点是为上市后疫苗安全性监测开展全球范围的努力。
这是一篇全面的综述，旨在探讨COVID-19疫苗加速研发和安全性监测的重要方面。它聚焦于长期安全性监测的监管要求、实际应用以及当前在为上市后监测建立强大药物警戒系统方面的全球努力。值得注意的是，纳入了来自行业、学术机构和参与药物安全的合同研究组织的作者的不同观点，以反映疫苗安全性方面的各种监管要求和新进展。所有共同作者均为国际药物警戒协会（ISoP）的现任成员。
