P131: REAL-TIME VACCINATION IMPACTS IN SICKLE CELL DISEASE: A REAL-WORLD PATIENT CASE STUDY FOR INFLUENZA AND COVID-19 VACCINATION

Abstract

Background: Sickle Cell Disease (SCD) comprises a group of red blood cell (RBC) disorders, with a diagnosed global population of ~20 million1. It is a chronic disease characterised by morphological RBC abnormalities in low oxygen due to β-globin mutation, causing vascular obstruction and complications including pain crisis and stroke2-4. The pandemic has seen patients with SCD face a higher risk of severe forms of COVID-19 infection and mortality5. Despite the approval of COVID-19 vaccinations, there is limited understanding of their impact in SCD. Evidence suggests that this has led to poor vaccine uptake due to patients feeling uncertain of their safety, potentially putting patients with SCD at risk, in addition to negatively impacting quality of life. Aims: To improve understanding of the real-world impacts of COVID-19 vaccination on both patient-reported outcomes and automatically recorded biometric datapoints in real-time, specifically in the context of Sickle Cell Disease, in order to support the improvement of patient confidence and vaccine uptake, thereby reducing COVID-19 risk. Methods: An FDA approved, CE marked smartwatch was provided to a 37 year old male with diagnosed HbSC following informed consent. This device was worn day and night over a 15-month period, automatically recording key biometrics including sleep quality, heart rate, and activity levels. This was supplemented by manual patient self-recording of SpO2 levels and ECG traces through the device, as well as self-reported pain scores (0–10, low-high), psychological scores (0–10, low-high), and symptoms entered via a patient-reported outcomes (PRO) portal. Metrics were compared as a 7-day pre-vaccination average, day of vaccination snapshot, and post-vaccination 2-day and 5-day average, in order to track any changes in patient wellbeing across the period following vaccination with reference to their baseline. Results: Live monitoring of day-by-day indicators of patient health revealed that, following an initial spike post-COVID-19 vaccination, physiological and psychological wellbeing metrics, as well as real-time biometrics such as sleep quality and activity levels, returned to pre-vaccination levels within 5 days.While pain scores remained statistically significantly high following influenza vaccination, this had returned to pre-vaccination levels over the 5-days following COVID-19 vaccine (Dose 1). Notably, while no significant difference was seen after 2-days of the second dose, pain scores had dropped significantly lower than even pre-vaccination levels post-Dose 2 in regards to the 5-day average. No significant changes were seen following the combined COVID-19 booster and flu vaccinations.Summary – Conclusion: Our data identifies trends in the temporary impact of COVID-19 vaccination upon both PROs and real-time biometric datapoints. However, PROs highlighted a lesser impact in comparison with more traditional influenza vaccination. Furthermore, these impacts were seen to resolve within 5 days following vaccination, with post-vaccination SpO2, activity levels, sleep quality, and PRO averages returning to pre-vaccination levels following this initial spike. No ECG abnormalities were recorded pre- or post-vaccination. In conclusion, this work indicates a visible but short-term impact of COVID-19 vaccination upon a patient with SCD, suggesting no heightened risk with COVID-19 vaccination in a previously poorly explored disease.