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Pandemic vaccines: a formidable challenge for pharmacovigilance

The COVID-19 vaccine effort was the most rapid global response to a health crisis in history. The challenge of managing unparalleled volumes of safety information provided unique opportunities to evaluate the robustness of current pharmaceutical industry pharmacovigilance practices and test novel approaches to strengthen safety signal detection, evaluation and communication.
By
  1. Alexandre Kiazand

    1. Global Patient Safety, Vaccines & Immune Therapies, AstraZeneca, Gaithersburg, MD, USA.

  2. Ruth Luther

    1. Global Patient Safety, QPPV & PV Excellence, AstraZeneca, Macclesfield, UK.

  3. Jessica Mårlind Würtele

    1. Global Patient Safety, QPPV & PV Excellence, AstraZeneca, Gothenburg, Sweden.

  4. Noel Southall

    1. Global Patient Safety, Patient Safety Operations, Technology & Analytics, AstraZeneca, Gaithersburg, MD, USA.

  5. Douglas Domalik

    1. Global Patient Safety, Patient Safety Operations, Technology & Analytics, AstraZeneca, Gaithersburg, MD, USA.

  6. Magnus Ysander

    1. Global Patient Safety, QPPV & PV Excellence, AstraZeneca, Gothenburg, Sweden.

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Pharmacovigilance (PV) systems are designed to monitor the safety of medicinal products and detect any change to their risk–benefit balance. They are used by industry organizations to ensure optimal communication of risk profiles to patients and healthcare providers in compliance with regulatory requirements relating to patient safety. PV systems require appropriate infrastructure, methodologies and resources to incorporate all available sources of safety information, including — but not limited to — literature, clinical and non-interventional trials, external database reviews and individual case safety reports (ICSRs) of suspected adverse reactions, for timely signal detection and management1.

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Nature Reviews Drug Discovery 22, 1-2 (2023)

doi: https://doi.org/10.1038/d41573-022-00178-z

References

  1. Arlett, P. et al. Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee. Nat. Rev. Drug Discov. 13, 395–397 (2014).

    Article  PubMed  Google Scholar 

  2. Folegatti, P. M. et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet 396, 467–478 (2020).

    Article  PubMed  Google Scholar 

  3. Voysey, M. et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 397, 99–111 (2021).

    Article  PubMed  Google Scholar 

  4. Kurz, X. et al. Safety monitoring of influenza A/H1N1 pandemic vaccines in EudraVigilance. Vaccine 29, 4378–4387 (2011).

    Article  PubMed  Google Scholar 

  5. Falsey, A. R. et al. Phase 3 safety and efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 vaccine. N. Engl. J. Med. 385, 2348–2360 (2021).

    Article  PubMed  Google Scholar 

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Supplementary Information

  1. Supplementary figures

Competing Interests

The authors are employees and shareholders of AstraZeneca.

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