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  6. Landscape Review Of Active Vaccine Safety Surveillance Activities For Covid-19 Vaccines Globally.

Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally.

Parisa A ShamaeiZadeh1,2, Carmen Villamizar Jaimes1, Maria Deloria Knoll1

  • 1International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.

Vaccine: X
|April 24, 2024

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View abstract on PubMed

Summary
This summary is machine-generated.

COVID-19 vaccine safety monitoring in low- and middle-income countries (LMICs) shows gaps, with most activities using cohort event monitoring. Investment is needed to build capacity for robust safety evidence generation and inform policy.

Area of Science:

  • Vaccinology
  • Public Health
  • Pharmacovigilance

Background:

  • Global COVID-19 vaccine safety evidence relied on existing infrastructure, despite known disparities between high-income countries (HICs) and low- and middle-income countries (LMICs).
  • Shortened development timelines and emergency use authorizations necessitated robust post-licensure safety monitoring.

Purpose of the Study:

  • To evaluate the global landscape of COVID-19 vaccine active surveillance system (AVSS) activities.
  • To identify deficiencies in safety evidence generation for various vaccine products and populations, with a specific focus on LMICs.

Main Methods:

  • A cross-sectional survey of AVSS activities assessing adverse events following immunization (AEFI) was conducted in January 2022.
  • A supplementary literature review of COVID-19 vaccine safety studies published in PubMed through January 2023 was performed, including observational studies on AEFI and adverse events of special interest (AESI).
Keywords:
Active surveillance systemCOVID-19SafetyVaccine

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  • Exclusions included systematic reviews, benefit/risk assessments, clinical trials, and case reports/series.
  • Main Results:

    • The survey identified 79 monitoring activities in HICs and 24 in LMICs. Most LMIC activities involved planned cohort event monitoring (CEM) studies.
    • A literature review of 379 eligible studies predominantly focused on vaccines used in HICs (e.g., Pfizer, Moderna).
    • Only 14 studies assessed vaccines exclusively used in LMICs, highlighting a significant gap in safety data for these populations.

    Conclusions:

    • Limited availability of robust safety evidence for COVID-19 vaccines used primarily in LMICs is likely due to the predominant use of CEM methods.
    • Equitable vaccine access necessitates parallel investment in infrastructure and capacity building for safety evidence generation in LMICs.
    • Enhanced safety monitoring in LMICs is crucial for informing local policy and regulatory decisions.