Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.
Centre for Academic Primary Care, School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK.
BMC Med. 2024 Jun 10;22(1):237. doi: 10.1186/s12916-024-03457-1.
Immunocompromised individuals are at increased risk of severe COVID-19 outcomes, underscoring the importance of COVID-19 vaccination in this population. The lack of comprehensive real-world data on vaccine uptake, effectiveness and safety in these individuals presents a critical knowledge gap, highlighting the urgency to better understand and address the unique challenges faced by immunocompromised individuals in the context of COVID-19 vaccination.
We analysed data from 12,274,946 people in the UK aged > 12 years from 01/12/2020 to 11/04/2022. Of these, 583,541 (4.8%) were immunocompromised due to immunosuppressive drugs, organ transplants, dialysis or chemotherapy. We undertook a cohort analysis to determine COVID-19 vaccine uptake, nested case-control analyses adjusted for comorbidities and sociodemographic characteristics to determine effectiveness of vaccination against COVID-19 hospitalisation, ICU admission and death, and a self-controlled case series assessing vaccine safety for pre-specified adverse events of interest.
Overall, 93.7% of immunocompromised individuals received at least one COVID-19 vaccine dose, with 80.4% having received three or more doses. Uptake reduced with increasing deprivation (hazard ratio [HR] 0.78 [95%CI 0.77-0.79] in the most deprived quintile compared to the least deprived quintile for the first dose). Estimated vaccine effectiveness against COVID-19 hospitalisation 2-6 weeks after the second and third doses compared to unvaccinated was 78% (95%CI 72-83) and 91% (95%CI 88-93) in the immunocompromised population, versus 85% (95%CI 83-86) and 86% (95%CI 85-89), respectively, for the general population. Results showed COVID-19 vaccines were protective against intensive care unit (ICU) admission and death in both populations, with effectiveness of over 92% against COVID-19-related death and up to 95% in reducing ICU admissions for both populations following the third dose. COVID-19 vaccines were generally safe for immunocompromised individuals, though specific doses of ChAdOx1, mRNA-1273 and BNT162b2 raised risks of specific cardiovascular/neurological conditions.
COVID-19 vaccine uptake is high in immunocompromised individuals on immunosuppressive drug therapy or who have undergone transplantation procedures, with documented disparities by deprivation. Findings suggest that COVID-19 vaccines are protective against severe COVID-19 outcomes in this vulnerable population, and show a similar safety profile in immunocompromised individuals and the general population, despite some increased risk of adverse events. These results underscore the importance of ongoing vaccination prioritisation for this clinically at-risk population to maximise protection against severe COVID-19 outcomes.
免疫功能低下的个体患严重 COVID-19 后果的风险增加，这突显了在该人群中接种 COVID-19 疫苗的重要性。在这些人群中，缺乏关于疫苗接种率、有效性和安全性的全面真实世界数据，这是一个关键的知识空白，强调了迫切需要更好地了解和应对免疫功能低下个体在 COVID-19 疫苗接种方面面临的独特挑战。
我们分析了来自英国 12274946 名年龄大于 12 岁的人群的数据，时间范围为 2020 年 12 月 1 日至 2022 年 4 月 11 日。其中，583541 人（4.8%）因免疫抑制药物、器官移植、透析或化疗而免疫功能低下。我们进行了队列分析以确定 COVID-19 疫苗接种率，进行嵌套病例对照分析以调整合并症和社会人口统计学特征，以确定疫苗对 COVID-19 住院、重症监护病房（ICU）入院和死亡的有效性，并进行自我对照病例系列研究以评估疫苗对预先指定的不良事件的安全性。
总体而言，93.7%的免疫功能低下个体至少接种了一剂 COVID-19 疫苗，80.4%的个体接种了三剂或更多剂。随着贫困程度的增加，疫苗接种率降低（第一剂时，最贫困五分位与最不贫困五分位相比，风险比[HR]0.78[95%CI 0.77-0.79]）。与未接种疫苗相比，第二剂和第三剂 COVID-19 疫苗接种后 2-6 周对 COVID-19 住院的估计疫苗有效性分别为 78%（95%CI 72-83）和 91%（95%CI 88-93），在免疫功能低下人群中，分别为 85%（95%CI 83-86）和 86%（95%CI 85-89）。结果表明，COVID-19 疫苗对重症监护病房（ICU）入院和死亡具有保护作用，在两人群中对 COVID-19 相关死亡的有效性均超过 92%，并在第三剂后降低 ICU 入院率达 95%。COVID-19 疫苗对免疫功能低下个体通常是安全的，但特定剂量的 ChAdOx1、mRNA-1273 和 BNT162b2 会增加特定心血管/神经系统疾病的风险。
接受免疫抑制药物治疗或接受过移植手术的免疫功能低下个体的 COVID-19 疫苗接种率较高，且存在贫困程度差异。研究结果表明，COVID-19 疫苗对这一脆弱人群的严重 COVID-19 结局具有保护作用，并且在免疫功能低下个体和一般人群中表现出相似的安全性，尽管某些不良事件的风险增加。这些结果强调了为这一临床高危人群持续进行疫苗接种优先级排序的重要性，以最大程度地降低严重 COVID-19 结局的风险。
