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. Descriptive sensitivity analysis was conducted to gain insight regarding underreporting of four outcomes at 16 sites. Findings: Estimated rates varied across countries and sites, ranging between 43·3-329·5 and 21·4-276·6/1000 livebirths for low birthweight and preterm birth respectively and 11·8-81/1,000 livebirths for SGA. No cases of congenital microcephaly were reported by three sites while the highest estimated rate was 13/1,000 livebirths. Neonatal infection and neonatal death rates varied between 1·8-73 and 0-59·9/1000 livebirths respectively while stillbirth rates ranged between 0-57·1/1000 total births across study sites. Results from the sensitivity analysis confirmed the underreporting of congenital microcephaly and SGA in our study. Interpretation: Our study establishes site-specific baseline rates for important adverse perinatal and neonatal outcomes and addresses a critical evidence gap towards improved monitoring of benefits and risks of emerging pregnancy and neonatal interventions. Funding: The study was sponsored by the World Health Organization with funding from the Bill and Melinda Gates Foundation.

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. To update the landscape analysis of no-fault compensation programmes and characterize VICP implementing countries, we conducted a survey of all 194 Member States from the World Health Organization and received feedback from 151. This analysis describes the economic and vaccine safety surveillance characteristics of Member States implementing VICPs. This analysis describes the characteristics of 25 Member States implementing a compensation programmes. Characteristics examined include economic, vaccination and safety surveillance indicators. Twenty of the 25 Member States (80%) with compensation programmes are categorized as high-income countries, 20/25 (80%) met the Global Vaccine Action Plan (GVAP) safety indicator of reporting at least ten annual reports of adverse events following immunization per 100,000 population, 21/25 (84%) met the GVAP coverage indicator by achieving greater than 90% third dose of Diphtheria, Tetanus and Pertussis vaccine (DTP3) and 17/25 (68%) assessed vaccine hesitancy in 2017. All Member States with VICP have a national immunization technical advisory group. This study identified growing interest in the implementation of no-fault compensation programs beyond high-income countries. Global policies guiding compensation should be developed for countries regardless of the maturity of their immunization programmes. RESEARCH IN CONTEXT: As a result of improved vaccine safety surveillance, World Health Organization (WHO) Member States are facing situations where known untoward serious vaccine reactions are documented, including in low- and middle-income settings. This has led to increased interest for the development of national no-fault compensation policies for vaccine injuries. As of 2010, compensation schemes for vaccine related injuries had been identified and characterized in 19 out of 194 WHO member states. All these programmes were in the industrialized world with none in low- and middle-income countries. Previous reviews have described the characteristics of the existing programmes based on the six common elements identified by Evans in 1999 with less emphasis on characteristics from countries implementing these no-fault compensation programmes. This manuscript aimed to identify predictors of countries implementing no-fault compensation programmes for vaccine injuries and update the inventory of existing programmes as part of a more comprehensive global landscape evaluation of existing programmes. This information will be useful for country self-evaluation and future compensation policy formulation as discussion to develop policies guiding the implementation of vaccine injury compensation continues to gain growing attention.