Abstract
PURPOSE: Following two fatal adverse reactions after yellow fever (YF) vaccination in the United Kingdom (UK) between 2018 and 2019, both involving unapproved use, the UK Medicines and Healthcare products Regulatory Agency (MHRA) mandated that the Marketing Authorisation Holder incorporate a checklist into the YF vaccine (STAMARIL) Risk Management Plan. This checklist was implemented as part of the local additional risk minimisation measures (aRMMs) in 2021, along with an updated patient information leaflet (PIL), to assist UK healthcare professionals (HCPs) in conducting risk-benefit evaluations during YF vaccination consultations. We evaluated the effectiveness of these interventions among HCPs at authorised YF vaccination centres and vaccinees across the UK. METHODS: Using a cross-sectional online survey among eligible UK HCPs and YF vaccinees in 2023, we assessed five effectiveness indicators: four for HCPs (aRMMs YF pre-vaccination checklist awareness, standardised YF pre-vaccination checklist utilisation, PIL distribution and knowledge and understanding of checklist's key safety messages) and one for vaccinees (PIL receipt). Each indicator was successful if achieved by ≥ 80% of the respondents. The proportion of desirable answers provided for each indicator with 95% confidence interval (CI) was calculated. RESULTS: Among the 153 HCPs who responded, 73.9% (95% CI: 66.4%-80.2%) were aware of the aRMMs checklist, 89.5% (95% CI: 83.7%-93.5%) utilised any standardised checklist(s), 92.2% (95% CI: 86.8%-95.5%) distributed the PIL to vaccinees and 46.4% (95% CI: 38.7%-54.3%) provided desirable answers to ≥ 80% of the questions on knowledge and understanding of key safety messages. Among 125 vaccinees who responded, 87.2% (95% CI: 80.2%-92.0%) confirmed PIL receipt. CONCLUSION: Three of the five effectiveness indicators were successful. Importantly, no YF vaccination errors were reported in the UK National Travel Health Network and Centre Annual Return reports (2021-2024) following aRMM implementation. Therefore, these findings suggest that the local aRMMs provide an effective framework for the safe administration of YF vaccine.