During the 2018–2020 Ebola virus disease (EVD) outbreak, residents in Goma, Democratic Republic of the Congo, were offered a two-dose prophylactic EVD vaccine. This was the first study to evaluate the safety of this vaccine in pregnant women. Adults, including pregnant women, and children aged ≥1 year old were offered the Ad26.ZEBOV (day 0; dose 1), MVA-BN-Filo (day 56; dose 2) EVD vaccine through an open-label clinical trial. In total, 20,408 participants, including 6635 (32.5%) children, received dose 1. Fewer than 1% of non-pregnant participants experienced a serious adverse event (SAE) following dose 1; one SAE was possibly related to the Ad26.ZEBOV vaccine. Of the 1221 pregnant women, 371 (30.4%) experienced an SAE, with caesarean section being the most common event. No SAEs in pregnant women were considered related to vaccination. Of 1169 pregnancies with a known outcome, 55 (4.7%) ended in a miscarriage, and 30 (2.6%) in a stillbirth. Eleven (1.0%) live births ended in early neonatal death, and five (0.4%) had a congenital abnormality. Overall, 188/891 (21.1%) were preterm births and 79/1032 (7.6%) had low birth weight. The uptake of the two-dose regimen was high: 15,328/20,408 (75.1%). The vaccine regimen was well-tolerated among the study participants, including pregnant women, although further data, ideally from controlled trials, are needed in this crucial group.

INTRODUCTION

Since November 2019, Medecins Sans Frontieres (MSF) and the Malawian Ministry of Health have provided a comprehensive range of cervical cancer care services. Initially, all consultations, pathological diagnoses, chemotherapy, surgery, and patient support activities were centralized at the tertiary hospital. To address the overwhelming surge in demand for these services, an innovative decentralisation approach was introduced to alleviate the workload and enhance patient care quality.

METHODS

The decentralization strategy involves triaging patients at the district level and categorizing them by type of lesion (Fig 1). Patients with early or locally advanced cancer, as well as those in need of palliative chemotherapy, are referred to the tertiary hospital for further evaluation and treatment. Those with premalignant lesions or advanced cancer are treated at the district level by trained surgical and palliative care teams. Quality is ensured through provision of medications, equipment and allowances, as well as monthly mentoring sessions for about 120 providers.

RESULTS

During the first months of comprehensive care provision, the number of palliative consultations at the tertiary hospital increased way above the threshold of 150 manageable consultations. Using the new decentralized system from August 2021, 818 palliative patients were referred to 45 palliative sites at district level, leading to a reduction in monthly consultations at central level from a high of 226 (2021) to a high of only 134 (2023) (Fig 2). Among the new patients presenting at the tertiary hospital, an average of 45% presented with benign or pre-malignant lesions. Therefore, from July 2023, 561 women started to be biopsied and managed at their district hospitals instead of the tertiary level.

CONCLUSIONS

It is feasible to provide a comprehensive package of cervical cancer care in low resource settings without overburdening services when a decentralization strategy is used to ensure manageable workload and high quality of care.