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Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?
  1. Sandeep Dhanda1,2,
  2. Vicki Osborne1,2,
  3. Elizabeth Lynn1,2,
  4. Saad Shakir1,2
  1. 1Drug Safety Research Unit, Southampton, Hampshire, UK
  2. 2School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, Hampshire, UK
  1. Correspondence to Dr Sandeep Dhanda, Drug Safety Research Unit, Southampton SO31 1AA, UK; sandeep.dhanda{at}


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.

  • vaccine-preventable diseases
  • vaccination
  • public health

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  • Contributors This article is important because postmarketing data are essential to provide real-world evidence on the use, effectiveness and safety of COVID-19 vaccines. Advancing vaccines quickly through the premarketing schedules merits even more rigorous postmarketing surveillance. All authors are all pharmacoepidemiologists and have worked in the field of drug safety for many years. They have extensive experience monitoring the safety of medicines and vaccines in the postmarketing phase in the UK and used previous studies as reference material for this paper. SD wrote the first draft of the manuscript. VO, EL and SAWS assisted with the concept, study design and writing the manuscript. All authors reviewed, contributed to revisions and approved the manuscript and accept full responsibility for its overall content. SAWS is the guarantor of this article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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