RT Journal Article
SR Electronic
T1 Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?
JF BMJ Evidence-Based Medicine
JO BMJ EBM
FD BMJ Publishing Group Ltd
SP bmjebm-2020-111507
DO 10.1136/bmjebm-2020-111507
A1 Sandeep Dhanda
A1 Vicki Osborne
A1 Elizabeth Lynn
A1 Saad Shakir
YR 2020
UL http://ebm.bmj.com/content/early/2020/10/21/bmjebm-2020-111507.abstract
AB In the current era of the COVID-19 pandemic, the world has never been more interested in the process of vaccine development. While researchers across the globe race to find an effective yet safe vaccine to protect populations from the newly emergent SARS-CoV-2 virus, more than one-third of the world has been subjected to either full or partial lockdown measures. With communities having felt the burden of prolonged isolation, finding a safe and efficacious vaccine will yield direct beneficial effects on protecting against COVID-19 morbidity and mortality and help relieve the psychological and economic load on communities living with COVID-19. There is hope that with the extraordinary efforts of scientists a vaccine will become available. However, given the global public health crisis, development of a COVID-19 vaccine will need to be fast tracked through the usual prelicensing development stages and introduced with limited clinical trial data compared with those vaccines that are developed conventionally over more than a decade. In this scenario, surveillance of the vaccine in the real world becomes even more paramount. This responsibility falls to observational researchers who can provide an essential safety net by continuing to monitor the effectiveness and safety of a COVID-19 vaccine after licensing. Postauthorisation observational studies for safety and effectiveness are complementary to prelaunch clinical trials and not a replacement. In this paper, we highlight the importance of postmarketing studies for future newly licensed COVID-19 vaccines and the key epidemiological considerations.