Background Although the SARS-CoV-2 vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions. Methods A post-hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, COVID-19 vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a “tempered immune system” (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS (NTIS) individuals starting at 14 days after completion of the primary series through the blinded phase for each of the four trials. An analysis of participants living with well-controlled HIV was conducted using the same methods. Results 3,852/30,351 (12.7%) Moderna participants, 3,088/29,868 (10.3%) Novavax participants, 3,549/32,380 (11.0%) AstraZeneca participants, and 5,047/43,788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (versus placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants vs NTIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with HIV. Conclusions For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared to those with non-tempered immune systems in the four COVID-19 vaccine randomized controlled efficacy trials.

中文翻译：

---

四项随机对照试验显示 COVID-19 疫苗对免疫系统较弱的参与者的功效

背景 尽管 SARS-CoV-2 疫苗对于预防普通人群的严重疾病非常有效，但目前缺乏关于疫苗对轻度免疫功能低下个体的功效 (VE) 的数据。方法对四项随机、安慰剂对照、COVID-19 疫苗 3 期试验（Moderna、阿斯利康、杨森和 Novavax）盲态阶段的参与者数据进行事后跨方案分析。我们通过基于病史和药物的共识小组定义了“调和免疫系统”(TIS) 变量，以确定 TIS 参与者与非 TIS (NTIS) 个体在完成后 14 天开始针对有症状和严重 COVID-19 病例的 VE初级系列通过四项试验中每一项的盲法阶段。使用相同的方法对艾滋病毒控制良好的参与者进行了分析。结果 3,852/30,351 (12.7%) 名 Moderna 参与者、3,088/29,868 (10.3%) 名 Novavax 参与者、3,549/32,380 (11.0%) 名阿斯利康参与者和 5,047/43,788 (11.5%) 名杨森 (Janssen) 参与者被确定患有 TIS。大多数 TIS 病症 (73.9%) 是由于代谢和营养障碍造成的。疫苗接种（与安慰剂相比）显着降低了每项试验的所有参与者出现症状和严重 COVID-19 的可能性。对于每项试验，TIS 参与者与 NTIS 对于有症状或严重的 COVID-19 的 VE 没有显着差异，对于 HIV 参与者的症状终点，VE 也没有显着差异。结论 在四项 COVID-19 疫苗随机对照疗效试验中，对于患有轻度免疫功能低下的个体，没有证据表明 VE 对抗有症状或严重的 COVID-19 的能力与免疫系统未调节的个体存在差异。