Pharmacovigilance of Maternal Vaccines in Africa: An Analysis of Reporting Patterns from VigiBase®, 2010–2024

Maternal immunisation is an effective strategy for reducing morbidity and mortality in pregnant women and neonates, yet it requires close safety monitoring, but safety surveillance capacity in Africa has historically been limited. The coronavirus disease 2019 (COVID-19) pandemic provided an unprecedented opportunity to evaluate Africa’s capacity for maternal vaccine pharmacovigilance and assess whether pandemic-era gains could be sustained. To characterize maternal vaccine safety reporting from Africa in VigiBase® (2010–2024), compare reporting patterns for COVID-19 and non-COVID vaccines, and identify priorities for strengthening maternal immunization safety surveillance A retrospective descriptive analysis of individual case safety reports submitted by African countries to VigiBase®, the World Health Organization global pharmacovigilance database, was conducted for January 2010 to December 2024. Reports were identified using the Uppsala Monitoring Centre pregnancy algorithm and classified according to the Brighton Collaboration Global Alignment of Immunisation Safety Assessment in Pregnancy adverse events following the maternal immunisation framework. Descriptive statistics and chi-square tests were used to compare COVID-19 and non-COVID vaccine reporting patterns, and a Mann–Whitney U test was used to compare pre-pandemic and pandemic annual reporting volumes. Africa contributed 817 of 44,316 global maternal vaccine safety reports (1.84%), submitted by 33 of 55 African countries. Of these, 573 (70.1%) were associated with COVID-19 vaccines and 244 (29.9%) with non-COVID-19 vaccines. Annual reporting increased markedly during the pandemic period (median 183.0 vs 4.5 reports/year; Mann–Whitney U test = 0.0, p = 0.004, effect size r = 0.785), with Africa’s global share rising from 0.49 to 2.48%. A total of 1619 adverse events were recorded across 817 reports. Adverse events following maternal immunisation category distributions differed significantly between vaccine types (χ2 = 200.6, df = 5, p < 0.001): COVID-19 vaccines were predominantly associated with maternal systemic events (36.9%) and unclassifiable reports (36.1%), whereas non-COVID vaccines generated proportionally more pregnancy outcome-specific events (25.3%) and fetal adverse events (8.1%). Physicians submitted the most reports but had the highest unclassifiable rate (52.3%), significantly exceeding all other reporter groups (χ2 = 125.0, df = 4, p < 0.001). Consumer reporting rose from one pre-pandemic report to 82 reports during 2021–24. The COVID-19 pandemic catalysed a substantial expansion in maternal vaccine pharmacovigilance in Africa, demonstrating the continent’s capacity to scale up surveillance rapidly. However, persistent gaps in data completeness and uneven country participation highlight the need for sustained embedded surveillance as new maternal vaccines targeting respiratory syncytial virus and group B Streptococcus are introduced. We examined reports of health events following vaccination in pregnant women in Africa between 2010 and 2024. Of 817 reports submitted by 33 African countries, most were received during the coronavirus disease 2019 pandemic, when reporting increased sharply. Events ranged from general symptoms such as fever to pregnancy-related outcomes. Nearly one in ten reports came directly from members of the public, suggesting that communities are willing to participate in vaccine safety monitoring. To build on pandemic-era gains, Africa needs stronger routine surveillance systems, better data quality mechanisms, and improved reporting tools for both health workers and the public.