Background: Despite the effectiveness of maternal vaccines, low- and middle-income countries grapple with inadequate safety monitoring systems. Robust safety surveillance is crucial to increasing vaccine confidence and timely identifying any potential safety signal that could put pregnant women and children at risk following vaccination. This study assessed the pharmacovigilance (PV) systems for vaccines used in pregnancy in Uganda. Methods: A qualitative study involves 13 key informant interviews and 8 focus group discussions among key stakeholders. Purposive sampling was used to select study participants. Data analysis was done using Miles and Huberman’s matrices approach and conducted in Atlas.ti software. Findings: A passive system involving multistakeholders at various levels of the healthcare structure existed but was inadequate for monitoring adverse events following maternal immunization. The existence of parallel reporting systems for vaccines was noted. Heavy workload, lack of feedback, inadequate knowledge to recognize and report adverse events following maternal immunizations and logistical challenges impeding reporting and follow-up were among the barriers to reporting. Electronic medical records, though underutilized for safety surveillance, offer promising potential. Conclusions: To address the specific needs of maternal vaccination, the PV system in Uganda needs improvement. A multipronged approach, including policy coherence, embracing active surveillance and leveraging existing birth outcome surveillance and electronic medical records, is essential. Harnessing healthcare provider knowledge and advisory committee capacity in causality assessment is also necessary. The study findings can inform priority interventions to enhance PV for existing and new maternal vaccines.

Although the World Health Organization recommends 2 tetanus vaccine-containing injections in pregnancy, in Uganda, only 59.2% of pregnant women received a 2nd dose in 2022. We set out to (1) create awareness of maternal vaccine-preventable diseases, maternal immunization benefits and vaccination safety through the use of media; (2) determine the effectiveness of maternal immunization campaigns and (3) assess stakeholder’s acceptability of project interventions’ delivery methods.

The aim of this study was to investigate perspectives on participation in a Group B Streptococcus (GBS) maternal vaccine trial among pregnant women, their partners, family members, friends and other stakeholders in Kampala, Uganda. We conducted focus group discussions, in-depth interviews and key informant interviews from October 2022 to February 2023 with 56 participants: 36 pregnant or breastfeeding women, 5 women not in the trial, 5 partners of women in trial, 5 healthcare workers, and 5 community stakeholders. This cross-sectional study was embedded within a GBS maternal vaccine trial conducted at the national referral hospital. All study participants were recruited after seeking hospital administrative approval and individual consent. Women taking part in the GBS trial were contacted by phone and invited to the hospital for detailed information during their follow-up visits. Eligible pregnant women were aged 18-39, and participating in a GBS maternal vaccine trial. Their identifiers were shared with the social science team after approval. With the support of the health visitors, the women were contacted. Non-trial participants with similar characteristics were recruited through antenatal clinic staff. Both groups were purposively sampled across age brackets (18-24 years, 25-32 years, 33-39 years) for discussion groups. Women's partners were recruited through contact information provided by the women, and community stakeholders were mobilized with assistance from a Community Advisory Board member. Healthcare workers involved in the trial, including doctors, nurses, and midwives, as well as a research ethics committee member, were directly approached and invited to participate. All participants provided informed consent. The participants expressed various concerns about participation of pregnant women in maternal vaccine trials. While family members, partners, friends, and community members, expressed concern for the safety of pregnant women and their unborn babies, the specific nature of these concerns and the focus on vaccine intentions differed. Pregnant women primarily focused on the safety of their babies, while partners and family members worried about both maternal and fetal safety. Friends were more concerned about the vaccine itself, community members were suspicious of vaccines in general, fear of possible harm and questioned the intent for vaccine development. Building trust, providing accurate information, and engaging in transparent communication about the safety and intentions of maternal vaccines are crucial steps in fostering understanding and increasing participation in vaccine trials. Efforts to dispel myths, correct misconceptions, and address the underlying fears that contribute to hesitancy within these diverse stakeholder groups need to be discussed with targeted study populations.