Nambasa Victoria Prudence, Ssebagereka Anthony, Ssali Agnes, Namugumya Ritah, Nalubega Phionah, Figueras Albert, Kajungu Dan, Koch Birgit, Le Doare Kirsty, Kampmann Beate
From the African Union Development Agency-New Partnership for Development, Johannesburg, South Africa.
Stellenbosch University, Stellenbosch, South Africa.
Pediatr Infect Dis J. 2025 Feb 1;44(2S):S123-S129. doi: 10.1097/INF.0000000000004705. Epub 2025 Feb 14.
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.
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.
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.
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.
尽管孕产妇疫苗有效，但低收入和中等收入国家仍面临安全监测系统不完善的问题。强大的安全监测对于增强疫苗信心以及及时识别接种疫苗后可能使孕妇和儿童面临风险的任何潜在安全信号至关重要。本研究评估了乌干达用于孕期的疫苗的药物警戒（PV）系统。
一项定性研究包括对13名关键信息提供者进行访谈，并与主要利益相关者进行8次焦点小组讨论。采用目的抽样法选择研究参与者。使用迈尔斯和休伯曼的矩阵方法进行数据分析，并在Atlas.ti软件中进行。
存在一个涉及医疗保健结构各级多个利益相关者的被动系统，但不足以监测孕产妇免疫接种后的不良事件。注意到存在疫苗平行报告系统。工作量大、缺乏反馈、识别和报告孕产妇免疫接种后不良事件的知识不足以及阻碍报告和随访的后勤挑战是报告的障碍。电子病历虽然在安全监测中未得到充分利用，但具有很大潜力。
为满足孕产妇疫苗接种的特殊需求，乌干达的PV系统需要改进。采取多管齐下的方法，包括政策一致性、采用主动监测以及利用现有的出生结局监测和电子病历至关重要。利用医疗保健提供者的知识和咨询委员会在因果关系评估方面的能力也很有必要。研究结果可为加强现有和新的孕产妇疫苗的PV的优先干预措施提供参考。
