Estimating baseline rates of adverse perinatal and neonatal outcomes using a facility-based surveillance approach: A prospective observational study from the WHO Global Vaccine Safety Multi-Country Collaboration on safety in pregnancy.

Background: Most perinatal and neonatal deaths occur in low- and middle-income countries (LMICs), yet, quality data on burden of adverse outcomes of pregnancy is limited in such countries.

Methods: A network of 21 maternity units, across seven countries, undertook surveillance for low birthweight, preterm birth, small for gestational age (SGA), stillbirths, congenital microcephaly, in-hospital neonatal deaths, and neonatal infections in a cohort of over 85,000 births from May 2019 - August 2020. For each outcome, site-specific rates per 1,000 livebirths (or per 1,000 total births for stillbirth) and 95% confidence intervals (CI) were calculated.

Operational lessons learned in conducting an international study on pharmacovigilance in pregnancy in resource-constrained settings: The WHO Global Vaccine safety Multi-Country collaboration project.

The WHO Global Vaccine Safety Multi-Country Collaboration study on safety in pregnancy aims to estimate the minimum detectable risk for selected perinatal and neonatal outcomes and assess the applicability of standardized case definitions for study outcomes and maternal immunization in low- and middle-income countries (LMICs). This paper documents the operational lessons learned from the study. A prospective observational study was conducted across 21 hospitals in seven countries.

WHO global vaccine safety multi-country collaboration project on safety in pregnancy: Assessing the level of diagnostic certainty using standardized case definitions for perinatal and neonatal outcomes and maternal immunization.

Standardized case definitions strengthen post-marketing safety surveillance of new vaccines by improving generated data, interpretation and comparability across surveillance systems. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project developed standardized case definitions for 21 key obstetric and neonatal terms following the Brighton Collaboration (BC) methodology. In this prospective cohort study, we assessed the applicability of GAIA definitions for maternal immunization exposure and for low birth weight (LBW), preterm birth, small for gestational age (SGA), stillbirth, neonatal death, neonatal infection, and congenital microcephaly.

Economic and immunisation safety surveillance characteristics of countries implementing no-fault compensation programmes for vaccine injuries.

Improvements in vaccine safety surveillance and investigative capacity lead to identification of rare reactions attributable to vaccination. As a result, the issue of fair compensation for those who experience vaccine injuries is gaining growing attention. Although vaccine injury compensation programmes (VICP) have been developed in a few countries for more than 50 years, no global policy guidance to guide vaccine injury compensation in all countries wishing to adopt such compensation schemes is currently available.

Mapping the landscape of global programmes to evaluate health interventions in pregnancy: the need for harmonised approaches, standards and tools.

Pregnant women and their babies are among the populations most vulnerable to untoward health outcomes. Yet current standards for evaluating health interventions cannot be met during pregnancy because of lack of adequate evidence. The situation is even more concerning in low-income and middle-income countries, where the need for effective interventions is the greatest.

Vaccine safety surveillance in pregnancy in low- and middle-income countries using GAIA case definitions: A feasibility assessment.

Background: Global efforts to adequately monitor safety of new vaccines for pregnant women in low and middle-income countries (LMICs) are needed. The Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) project recently published case definitions based on levels of diagnostic certainty for pregnancy- and neonatal outcomes and maternal vaccination. As a preliminary step to assessing the applicability of these definitions in LMICs, WHO selected sites and conducted a feasibility assessment to evaluate their ability to identify and classify selected outcomes (preterm birth, neonatal death, neonatal invasive bloodstream infection (NI-BSI), stillbirth) and maternal vaccination.

Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative.

Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle- income countries (LMICs) is essential. The study tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing. Twenty-six sentinel sites in sixteen countries across all WHO regions participated, and 65% of the sites were from LMIC.