Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review

Hannah G. Davies*, Emma V. Thorley, Rossul Al-Bahadili, Natalina Sutton, Jessica Burt, Lauren Hookham, Kostas Karampatsas, Philipp Lambach, Flor Muñoz, Clare L. Cutland, Saad Omer, Kirsty Le Doare

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract

Introduction: The GAIA (Global Alignment on Immunisation Safety Assessment in Pregnancy) consortium was established in 2014 with the aim of creating a standardised, globally coordinated approach to monitoring the safety of vaccines administered in pregnancy. The consortium developed twenty-six standardised definitions for classifying obstetric and infant adverse events. This systematic review sought to evaluate the current state of adverse event reporting in maternal vaccine trials following the publication of the case definitions by GAIA, and the extent to which these case definitions have been adopted in maternal vaccine safety research. Methods: A comprehensive search of published literature was undertaken to identify maternal vaccine research studies. PubMed, EMBASE, Web of Science, and Cochrane were searched using a combination of MeSH terms and keyword searches to identify observational or interventional studies that examined vaccine safety in pregnant women with a comparator group. A two-reviewer screening process was undertaken, and a narrative synthesis of the results presented. Results: 14,737 titles were identified from database searches, 435 titles were selected as potentially relevant, 256 were excluded, the remaining 116 papers were included. Influenza vaccine was the most studied (25.0%), followed by TDaP (20.7%) and SARS-CoV-2 (12.9%). Ninety-one studies (78.4%) were conducted in high-income settings. Forty-eight (41.4%) utilised electronic health-records. The majority focused on reporting adverse events of special interest (AESI) in pregnancy (65.0%) alone or in addition to reactogenicity (27.6%). The most frequently reported AESI were preterm birth, small for gestational age and hypertensive disorders. Fewer than 10 studies reported use of GAIA definitions. Gestational age assessment was poorly described; of 39 studies reporting stillbirths 30.8% provided no description of the gestational age threshold. Conclusions: Low-income settings remain under-represented in comparative maternal vaccine safety research. There has been poor uptake of GAIA case definitions. A lack of harmonisation and standardisation persists limiting comparability of the generated safety data.

Original languageEnglish
Article number100464
JournalVaccine: X
Volume18
DOIs
Publication statusPublished - Jun 2024
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2024 The Authors

Keywords

  • Maternal interventions vigilance
  • Pharmacovigilance
  • Pregnancy
  • Safety
  • Vaccines

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