Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries

Watson, Gabriella; Dodd, Caitlin; Muñoz, Flor M.; Eckert, Linda O.; Jones, Christine E; Buttery, Jim; Yıldırım, İnci; Kachikis, Alisa; Heath, Paul T.; Schlaudecker, Elizabeth P.; Bond, Nanette; Santarcangelo, Patricia; Wilcox, Christopher R; Bellamy, Karen; Elmontser, Mohnd; Sienas, Laura; Simon, Rebecca; Khalil, Asma; Townsend, Rosemary; Sturkenboom, Miriam; Black, Steve

doi:10.1097/inf.0000000000003261

Cited by 7 publications

(16 citation statements)

References 25 publications

(26 reference statements)

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“…A study from South Africa and The Gambia assessed three CDs and one enabling term – gestational age (GA) in retrospective data from two randomized controlled trials 38 . The most recently published study focused on applicability of 10 definitions in retrospective data from high‐income settings 39 …”

Section: Resultsmentioning

confidence: 99%

“…Watson et al 39 assessed positive predictive value (PPV) of the CDs compared with ICD‐10 codes. Microcephaly, pathways to preterm labour, non‐reassuring fetal status and dysfunctional labor performed poorly with PPVs of below 50%, but this was mainly driven by the quality of documentation and quantity of missing data available in the medical records 39 .…”

Section: Resultsmentioning

confidence: 99%

“…KLD is principal investigator for the Ugandan study; she has no other conflicts to report. CEJ was a member of the GAIA working group and author of a GAIA case definitions; she was an author of one of the studies assessed in this manuscript (Watson et al 39 ). GW was author of one of the studies assessed in this manuscript (Watson et al 39 ).…”

Section: Co N Fli C T O F I Nte R E S T S Tate M E Ntmentioning

confidence: 99%

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Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date

Davies

Bowman

Watson

et al. 2023

Intl J Gynecology & Obste

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Co N Fli C T O F I Nte R E S T S Tate M E Ntmentioning

confidence: 99%

See 1 more Smart Citation

Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date

Davies

Bowman

Watson

et al. 2023

Intl J Gynecology & Obste

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“…In response to the call of WHO for a globally concerted approach to monitoring the safety of vaccines in pregnancy, the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project was launched in 2015 [ 2 , 7 , 8 ] with the objective of establishing standardized definitions for obstetric and neonatal outcomes to increase the comparability of safety data across research studies and surveillance systems. In the present study, we will also assess the applicability of GAIA case definitions to our recruited cases, in order to inform future vaccine safety studies and provide a gold-standard reference for the implementation of these definitions in the LMIC countries as part of the WHO-GVS-MCC study [ 6 , 7 , 8 , 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

Risk Measurement of Perinatal and Neonatal Morbidity Characteristics and Applicability of GAIA Case Definitions: Results and Lessons Learnt of a Hospital-Based Prospective Cohort Study in the Valencia Region (2019–2020)

Carmona

Tejerina

Sebastián

et al. 2022

IJERPH

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Post-marketing safety surveillance of new vaccines aimed to be administered during pregnancy is crucial to orchestrate efficient adverse events evaluation. This is of special relevance in the current landscape of new vaccines being introduced in the pregnant women population, and particularly due to the recent administration of COVID-19 vaccines in pregnant women. This multi-center prospective cohort study, nested within the WHO-Global Vaccine Safety-MCC study, involved two hospitals in the Valencia region. Hereby, the incidence rates of seven perinatal and neonatal outcomes in the Valencia region are presented. The pooled data analysis of the two Valencian hospitals allowed the estimation of incidence rates in the Valencia Region (per 1000 live births): 86.7 for low birth weight, 78.2 for preterm birth, 58.8 for small for gestational age, 13 for congenital microcephaly, 0.4 for stillbirth, 1.2 for neonatal death and 6.5 for neonatal infection. These figures are in line with what is expected from a high-income country and the previously reported rates for Spain and Europe, except for the significantly increased rate for congenital microcephaly. Regarding the data for maternal immunization, the vaccination status was collected for 94.4% of the screened pregnant women, highlighting the high quality of the Valencian Vaccine Registry. The study also assessed the Valencian hospitals’ capacity for identifying and collecting data on maternal immunization status, as well as the applicability of the GAIA definitions to the identified outcomes.

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“…Recently, it has been used by many LMICs for the follow-up of patients diagnosed with COVID-19 and as a register of COVID-19 vaccination. (6) The INDEPTH network is currently composed of more than forty-member health research centers that observe through Health and Demographic Surveillance Systems (HDSSs) in 19 LMICs in Africa, Asia, and Oceania. (7) GNMNHR is a prospective, population-based registry implemented in areas of low-resource countries for research purposes.…”

Section: Introductionmentioning

confidence: 99%

Assessment of data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries through key informant’s interviews

Belizán,

Cairoli,

Mazzoni

et al. 2022

Preprint

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Background: There is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to use this tool in sites using MNCH data collection systems through informant interviews.Methods: We conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to complete the domains included in the assessment tool. Results: We interviewed a total of 9 stakeholders including: central-level systems key informants and/or site level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). Similarities among sites were found regarding some domains such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy such as routine collection of MNCH individual data, and capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR)Conclusion: This study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by integrating the currently used individual MNCH data collection systems in some sites in LMICs.

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Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries

Abstract: Supplemental Digital Content is available in the text.

Cited by 7 publications

References 25 publications

Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date

Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date

Risk Measurement of Perinatal and Neonatal Morbidity Characteristics and Applicability of GAIA Case Definitions: Results and Lessons Learnt of a Hospital-Based Prospective Cohort Study in the Valencia Region (2019–2020)

Assessment of data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries through key informant’s interviews

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