Pregnant Women and Vaccine Safety in Uganda: Knowledge, Barriers, and Opportunities for Engagement.

Background/Objectives: New vaccines designed to combat infections such as Group B Streptococcus and respiratory syncytial virus will soon be accessible in Africa. While outbreak response vaccines are given to pregnant women, safety data for maternal vaccines in low- and middle-income countries (LMICs) are limited. This study explored Ugandan pregnant women's knowledge, attitudes, and engagement in adverse event reporting and vaccine decision-making. Methods: This nested qualitative study was part of a national gap analysis of pharmacovigilance systems for maternal vaccines. Five Focus Group Discussions (FGDs), each involving eight participants, were held with pregnant and or breastfeeding women at four healthcare facilities and one research center. The data collected from these discussions were analyzed thematically using a manifest content analysis, conducted in Atlas.ti software version 9 for qualitative data analysis. Results: Women valued maternal vaccines, particularly tetanus, but reported confusion about schedules and hesitancy when informed of potential side effects. Many adverse events were normalized, therefore not reported, and most participants were unaware of national reporting mechanisms beyond informing healthcare providers. Barriers included inadequate information, dismissive or rushed provider interactions and reliance on family, peers, and informal care networks to manage side effects. Women expressed a strong desire to be informed and actively involved in decisions about pregnancy vaccines, including the introduction of new vaccines. Conclusions: Strengthening maternal vaccine safety monitoring requires clearer, balanced communication; simplified and well-publicized reporting tools; supportive provider-patient interactions; and integration of community and informal networks. Pregnant women should be engaged as active partners in pharmacovigilance and maternal vaccine introduction to build trust, improve adverse event reporting, and support vaccine uptake.