Importance As part of postauthorization safety surveillance, the US Food and Drug Administration (FDA) has identified a potential safety concern for Guillain-Barré syndrome (GBS) following receipt of the Ad26.COV2.S (Janssen/Johnson & Johnson) COVID-19 vaccine. Objective To assess reports of GBS received in the Vaccine Adverse Event Reporting System (VAERS) following Ad26.COV2.S vaccination. Design, Setting, and Participants Reports of presumptive GBS were identified in a US passive reporting system (VAERS) February-July 2021 and characterized, including demographics, clinical characteristics, and relevant medical history. Exposures Receipt of the Ad26.COV2.S vaccine; the comparator was the background rate of GBS in the general (unvaccinated) population that had been estimated and published based on a standardized case definition. Main Outcomes and Measures Presumptive GBS; the reporting rate was analyzed, including calculation of the observed to expected ratio based on background rates and vaccine administration data. Because of limited availability of medical records, cases were not assessed according to the Brighton Collaboration criteria for GBS. Results As of July 24, 2021, 130 reports of presumptive GBS were identified in VAERS following Ad26.COV2.S vaccination (median age, 56 years; IQR, 45-62 years; 111 individuals [86.0%] were < 65 years; 77 men [59.7%]). The median time to onset of GBS following vaccination was 13 days (IQR, 10-18 days), with 105 cases (81.4%) beginning within 21 days and 123 (95.3%) within 42 days. One hundred twenty-one reports (93.1%) were serious, including 1 death. With approximately 13 209 858 doses of vaccine administered to adults in the US, the estimated crude reporting rate was 1 case of GBS per 100 000 doses administered. The overall estimated observed to expected rate ratio was 4.18 (95% CI, 3.47-4.98) for the 42-day window, and in the worst-case scenario analysis for adults 18 years or older, corresponded to an estimated absolute rate increase of 6.36 per 100 000 person-years (based on a rate of approximately 8.36 cases per 100 000 person-years [123 cases per 1 472 162 person-years] compared with a background rate of approximately 2 cases per 100 000 person-years). For both risk windows, the observed to expected rate ratio was elevated in all age groups except individuals aged 18 through 29 years. Conclusions and Relevance These findings suggest a potential small but statistically significant safety concern for Guillain-Barré syndrome following receipt of the Ad26.COV2.S vaccine. However, the findings are subject to the limitations of passive reporting systems and presumptive case definition, and they must be considered preliminary pending analysis of medical records to establish a definitive diagnosis.

中文翻译：

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2021 年 2 月至 7 月 Ad26.COV2.S COVID-19 疫苗与推定格林-巴利综合征的收据关联。

重要性 作为授权后安全监督的一部分，美国食品和药物管理局 (FDA) 在收到 Ad26.COV2.S (Janssen/Johnson & Johnson) COVID-19 后确定了格林-巴利综合征 (GBS) 的潜在安全问题疫苗。目的 评估 Ad26.COV2.S 疫苗接种后疫苗不良事件报告系统 (VAERS) 收到的 GBS 报告。设计、设置和参与者 2021 年 2 月至 7 月在美国被动报告系统 (VAERS) 中确定了推定 GBS 的报告，并对其进行了描述，包括人口统计学、临床特征和相关病史。Ad26.COV2.S 疫苗的暴露收据；比较对象是根据标准化病例定义估计和公布的一般（未接种疫苗）人群中 GBS 的背景率。主要结果和措施推定 GBS；对报告率进行了分析，包括根据背景率和疫苗接种数据计算观察到的与预期的比率。由于医疗记录的可用性有限，未根据布莱顿合作组织的 GBS 标准对病例进行评估。结果截至 2021 年 7 月 24 日，在 Ad26.COV2.S 疫苗接种后，在 VAERS 中发现了 130 例推定 GBS 报告（中位年龄，56 岁；IQR，45-62 岁；111 人 [86.0%] 小于 65 岁；77男性 [59.7%]）。接种疫苗后发生 GBS 的中位时间为 13 天（IQR，10-18 天），其中 105 例（81.4%）在 21 天内开始，123 例（95.3%）在 42 天内开始。121 份报告（93.1%）是严重的，包括 1 人死亡。在美国，大约有 13209858 剂疫苗用于成人，估计的粗略报告率为每 100000 剂接种 1 例 GBS。在 42 天窗口中，总体估计观察到的比率与预期比率为 4.18（95% CI，3.47-4.98），在 18 岁或以上成年人的最坏情况分析中，估计的绝对增长率为 6.36每 100 000 人年（基于每 100 000 人年约 8.36 例病例[每 1 472 162 人年 123 例病例]，而背景率为每 100 000 人年约 2 例）。对于这两个风险窗口，除 18 至 29 岁的个体外，所有年龄组的观察到预期比率均有所提高。结论和相关性 这些发现表明，在接受 Ad26.COV2.S 疫苗后，Guillain-Barré 综合征存在潜在的小但具有统计学意义的安全问题。然而，调查结果受到被动报告系统和推定病例定义的限制，并且必须考虑对医疗记录进行初步未决分析以确定明确诊断。