Clinical Practice Recommendations on the Effect of COVID‐19 Vaccination Strategies on Outcomes in Solid Organ Transplant Recipients

INTRODUCTION: Solid organ transplant (SOT) recipients were excluded from clinical trials evaluating the efficacy of COVID-19 vaccines. There is uncertainty about the number of doses required to prevent life-threatening infection, as well as uncertainty in the optimal vaccine type and their durability. Our objectives were to provide recommendations on the number of COVID-19 vaccination doses, type of vaccine, dose of vaccine administered, and timing of vaccination in SOT recipients. METHODS: We commissioned a systematic review on COVID-19 vaccination in SOT, focusing on patient-important outcomes. We recruited an international, multidisciplinary panel of 18 stakeholders, including patient partners to summarize our findings using the GRADE (grading of recommendation, assessment, development, and evaluation) framework, rate certainty in the evidence, and develop recommendations. RESULTS: Our panel recommends the routine provision of additional COVID-19 doses after the primary series to SOT recipients with variant-appropriate vaccines (strong recommendation, low certainty evidence). We suggest using any available WHO-approved vaccine rather than selectively choosing a specific type and receiving a single dose rather than a double dose of any COVID-19 vaccine booster (weak recommendation, low certainty evidence). Lastly, we suggest vaccination before transplantation when possible (weak recommendation, low certainty evidence). CONCLUSION: The evidence used to guide these recommendations is limited by the paucity of robust randomized trials evaluating COVID-19 vaccination strategies and clinical outcomes in the SOT population. The provision of higher-quality evidence of the overall effects of COVID-19 vaccination in SOT to inform clinical practice will require large, randomized trials.