Assessing the Safety of COVID-19 Vaccines: A Primer
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CURRENT OPINION
Assessing the Safety of COVID‑19 Vaccines: A Primer Helen Petousis‑Harris1 Accepted: 10 September 2020 © Springer Nature Switzerland AG 2020
Abstract Vaccines against COVID-19 are being developed at speeds not previously achieved. With this unprecedented effort comes challenges for post-marketing safety monitoring and challenges for vaccine safety communication. To deploy these new vaccines fast across diverse populations, it is vital that robust pharmacovigilance and active surveillance systems are in place. Not all countries have the capability or resources to undertake adequate surveillance and will rely on data from those who can. The tools exist to assess COVID-19 vaccines as they are deployed such as surveillance systems, administrative data and case definitions for adverse events of special interest. However, stitching these all together and using them effectively requires investment and collaboration. This paper provides a high-level overview of some of the facets of modern vaccine safety assessment and how they are, or can be, applied to COVID-19 vaccines.
Key Points COVID-19 vaccines are being developed at an unprecedented speed leading to concerns about adequate safety assessments before deployment. There are many entities tasked with assessing and monitoring vaccine safety at the global and national levels and prior experience in enhanced vaccine safety activities. We have the tools to intensively monitor and assess the safety of COVID-19 vaccines as they are deployed, providing there is coordination and collaboration.
1 Introduction An unprecedented commitment to developing and producing vaccines against SARS-CoV-2 in record time is underway and new candidates are entering clinical testing almost weekly. The speed at which development is unfolding has led to widespread concern among both health professionals and the public that vital steps may be skipped, in particular the assessment of safety. * Helen Petousis‑Harris h.petousis‑[email protected] 1
Department of General Practice and Primary Health Care, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
Vaccine development has traditionally been a long process taking an average of 10–15 years. The vaccine with the shortest timeline from antigen discovery to licensure is the mumps vaccine, which took 4 years. It is the high financial cost, particularly high-risk advanced clinical development, coupled with the investment in production facilities that has, in part, hampered nimble vaccine responses to emerging infectious diseases. However, recent developments in technology along with unprecedented collaboration and investment mean we may be able to escape the barriers of the past [1]. As well as the speed at which vaccine candidates were advanced, where possible the clinical development and regulatory phases are occurring alongside each other rather than sequentially [2]. This means that while all steps are adhered to, their timing can be expedited. The desperate need for an Ebola vaccine g
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