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Using maternal and neonatal data collection systems for coronavirus disease 2019 (COVID-19) vaccines active safety

Veronica Pingray1, María Belizán1, Sarah Matthews2

  • 1Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Ciudad de Buenos Aires, Buenos Aires, 1414, Argentina.

Gates Open Research
|July 25, 2024
PubMed

Insights

Experts recommend using existing maternal and neonatal data systems for COVID-19 vaccine safety surveillance in low- and middle-income countries (LMICs). A consensus was reached on a core set of 14 variables for this critical public health surveillance.

Area of Science:

  • Public Health
  • Vaccinology
  • Epidemiology

Background:

  • Pregnant women are now eligible for COVID-19 vaccines, necessitating robust safety surveillance systems.
  • Existing maternal and neonatal data collection systems in LMICs are potential resources for this surveillance.
  • Ensuring vaccine safety in diverse populations, including pregnant women in LMICs, is crucial.

Purpose of the Study:

  • To achieve consensus on utilizing LMIC maternal/neonatal data systems for COVID-19 vaccine safety surveillance.
  • To define a core set of variables for this surveillance.
  • To assess the suitability and feasibility of including pregnant women and LMIC networks in vaccine research.

Main Methods:

  • A three-stage modified Delphi study was conducted over three months in 2020.
  • An international multidisciplinary panel of 16 experts participated.
  • Consensus was determined by analyzing rating distributions and rationale.

Main Results:

  • The panel recommended using existing maternal and neonatal data systems for surveillance in LMICs.
  • Consensus was achieved on a basic set of 14 maternal, neonatal, and vaccination variables.
  • Inclusion of pregnant women in vaccine research was deemed appropriate, though feasibility faced uncertainties regarding decision-maker acceptability and regulatory aspects.

Conclusions:

  • Maternal and neonatal data collection systems are recommended for COVID-19 vaccine safety surveillance in LMICs.
  • A common set of 14 variables was agreed upon for effective surveillance.
  • While feasibility challenges exist, the proposed approach supports vaccine safety monitoring in vulnerable populations and settings.

Keywords:
COVID-19 vaccineDelphi Techniqueactive safety surveillancepregnancy

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