Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD.
Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
Transplantation. 2021 Oct 1;105(10):2170-2174. doi: 10.1097/TP.0000000000003780.
We studied the safety and reactogenicity SARS-CoV-2 mRNA vaccines in transplant recipients because immunosuppressed patients were excluded from vaccine trials.
US transplant recipients were recruited into this prospective cohort study through social media; those who completed the full vaccine series between December 9, 2020 and March 1, 2021 were included. We collected demographics, medical history, and safety information within 7 d after doses 1 and 2 (D1, D2). Associations between characteristics and reactions were evaluated using modified Poisson regression.
We studied 741 transplant recipients who underwent BNT162b2 (54%) or mRNA-1273 (46%) vaccination. Median (interquartile range) age was 60 (44-69) y, 57% were female, and 10% were non-White. Although local site reactions decreased after D2 (85% D1 versus 78% D2, P < 0.001), systemic reactions increased (49% D1 versus 69% D2, P < 0.001). Younger participants were more likely to develop systemic symptoms after D1 (adjusted incidence rate ratio [aIRR] per 10 y = 0.850.900.94, P < 0.001) and D2 (aIRR per 10 y = 0.910.930.96, P < 0.001). Participants who experienced pain (aIRR = 1.111.662.47, P = 0.01) or redness (aIRR = 1.833.928.41, P < 0.01) were more likely to develop an antibody response to D1 of mRNA vaccines. No anaphylaxis, neurologic diagnoses, or SARS-CoV-2 diagnoses were reported. Infections were minimal (3% after D1, <0.01% after D2). One patient reported incident acute rejection post-D2.
In solid organ transplant recipients undergoing mRNA vaccination, reactogenicity was similar to that reported in the original trials. Severe reactions were rare. These early safety data may help address vaccine hesitancy in transplant recipients.
我们研究了 SARS-CoV-2 mRNA 疫苗在移植受者中的安全性和反应原性，因为免疫抑制患者被排除在疫苗试验之外。
我们通过社交媒体招募美国移植受者参加这项前瞻性队列研究；那些在 2020 年 12 月 9 日至 2021 年 3 月 1 日之间完成全系列疫苗接种的人被纳入研究。我们在接种第 1 剂（D1）和第 2 剂（D2）后 7 天内收集人口统计学、病史和安全性信息。使用修正后的泊松回归评估特征与反应之间的关系。
我们研究了 741 名接受 BNT162b2（54%）或 mRNA-1273（46%）疫苗接种的移植受者。中位（四分位间距）年龄为 60（44-69）岁，57%为女性，10%为非白人。尽管 D2 后局部反应部位减少（85% D1 比 78% D2，P<0.001），但全身反应增加（49% D1 比 69% D2，P<0.001）。年轻的参与者在 D1 后更有可能出现全身症状（每增加 10 岁的调整发病率比 [aIRR]分别为 0.850.900.94，P<0.001）和 D2（aIRR 每增加 10 岁为 0.910.930.96，P<0.001）。经历疼痛（aIRR=1.111.662.47，P=0.01）或发红（aIRR=1.833.928.41，P<0.01）的参与者更有可能对 D1 型 mRNA 疫苗产生抗体反应。未报告过敏反应、神经系统诊断或 SARS-CoV-2 诊断。感染发生率较低（D1 后 3%，D2 后<0.01%）。1 例患者在 D2 后报告新发急性排斥反应。
在接受 mRNA 疫苗接种的实体器官移植受者中，反应原性与原始试验报告的相似。严重反应很少见。这些早期安全性数据可能有助于解决移植受者的疫苗犹豫问题。
