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. 2020 Dec;43(12):1205-1210.
doi: 10.1007/s40264-020-01002-6. Epub 2020 Sep 30.

Assessing the Safety of COVID-19 Vaccines: A Primer

Helen Petousis-Harris  1
Affiliations

Assessing the Safety of COVID-19 Vaccines: A Primer

Helen Petousis-Harris. Drug Saf. 2020 Dec.

Erratum in

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.

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Conflict of interest statement

Helen Petousis-Harris is engaged in a global collaboration that aims to assess vaccine safety and risk benefit.

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