(338) Effectiveness Evaluation of the Additional Risk Minimisation Measures for Yellow Fever Vaccine in the United Kingdom: A Survey for Healthcare Professionals and Vaccinees

Background: Stamaril® (Sanofi) is a live attenuated yellow fever (YF) vaccine. Qualified healthcare professionals (HCPs) of designated authorised YF vaccination centres are responsible for providing travel health consultation to YF vaccinees using a standardised checklist such as traveller’s checklist in the UK. Following the implementation of a pre-vaccination Stamaril checklist as part of the additional Risk Minimisation Measures (aRMMs) and an updated patient information leaflet (PIL) for Stamaril in November 2021 in the UK, we conducted a study to evaluate the effectiveness of these aRMMs.

Objectives: Among qualified HCPs - to measure awareness of the Stamaril checklist, utilisation of any standardised checklist(s), distribution of the PIL, and to evaluate knowledge and understanding of the key safety messages of any standardised checklist(s); among YF vaccinees - to verify the receipt of the PIL.

Methods: We conducted a cross-sectional web-based survey among qualified HCPs and YF vaccinees separately from March to August 2023 in the UK. Four effectiveness indicators were developed for HCPs namely awareness and utilisation of checklist(s), distribution of the PIL, and knowledge and understanding of key safety messages. One indicator, i.e., receipt of PIL, was developed for vaccinees. Each indicator was considered successful if ≥ 80% of the respondents provided desirable answers. All the analyses were descriptive and Wilson confidence intervals (CI) of 95% was estimated for each indicator.

Results: A total of 153 HCPs and 125 YF vaccinees completed the questionnaires; most were from England (HCPs: 95%; vaccinees: 67%). Among HCPs, 74% (95% CI: 66%-80%) were aware of the Stamaril checklist, 90% (95% CI: 84%-94%) utilised one standardised checklist, 92% (95% CI: 87%-96%) distributed the PIL to vaccinees, and 46% (95% CI: 39%-54%) provided desirable answers to ≥ 22 out of 27 questions (80%) related to knowledge and understanding of key safety messages. A total of 87% of YF vaccinees (95% CI: 80%-92%) confirmed receipt of the PIL.

Conclusions: The effectiveness of aRMMs was successful among the YF vaccinees, but not among the HCPs as the predefined success criteria were not met for two effectiveness indicators. The objective of the Stamaril checklist is to ensure compliance of HCPs with indications, contraindications, warnings, and precautions of YF vaccine in the UK. Although the indicator for knowledge and understanding of key safety messages was not successful, 90% of the responding HCPs utilised one standardized checklist. Therefore, this finding highlights the need to review the knowledge and understanding indicator to understand why it is not successful among the HCPs.