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Assessing the Safety of COVID-19 Vaccines: A Primer.
Petousis-Harris, Helen.
  • Petousis-Harris H; Department of General Practice and Primary Health Care, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. h.petousis-harris@auckland.ac.nz.
Drug Saf ; 43(12): 1205-1210, 2020 12.
Article in English | MEDLINE | ID: covidwho-1092870
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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Product Surveillance, Postmarketing / Drug Development / COVID-19 Vaccines / COVID-19 Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Drug Saf Journal subject: Drug Therapy / Toxicology Year: 2020 Document Type: Article Affiliation country: S40264-020-01002-6

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Product Surveillance, Postmarketing / Drug Development / COVID-19 Vaccines / COVID-19 Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Drug Saf Journal subject: Drug Therapy / Toxicology Year: 2020 Document Type: Article Affiliation country: S40264-020-01002-6