Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Pharmacoepidemiol Drug Saf. 2022 Nov;31(11):1174-1181. doi: 10.1002/pds.5523. Epub 2022 Sep 5.
The Food and Drug Administration (FDA) has identified a potential safety concern for thromboembolic events (TEEs) after Ad.26.COV2.S COVID-19 Vaccine. We sought to characterize the frequency, severity, type, and anatomic location of TEEs reported to the Vaccine Adverse Event Reporting System (VAERS) following Ad.26.COV2.S.
Reports of TEEs after Ad.26.COV2.S were identified in VAERS, and demographics, clinical characteristics, and relevant medical history were summarized. For a subset of reports, physicians reviewed available medical records and evaluated clinical presentation, diagnostic evaluation, risk factors, and treatment. The crude reporting rate of TEEs was estimated based on case counts in VAERS and vaccine administration data.
Through February 28, 2022, FDA identified 3790 reports of TEEs after Ad.26.COV2.S. Median age was 56 years, and 1938 individuals (51.1%) were female. Most reports, 2892 (76.3%), were serious, including 421 deaths. Median time to onset was 12 days post-vaccination. Obesity and ischemia were among the most commonly documented risk factors. Thrombocytopenia (platelet count less than 150 000/μl) was documented in 63 records (11.5%) and anti-platelet 4 antibodies in 25 (4.6%). Medical review identified cases of severe clot burden (e.g., bilateral, saddle, or other massive pulmonary embolism with or without cor pulmonale; lower extremity thrombus involving the external iliac, common femoral, popliteal, posterior tibial, peroneal, and gastrocnemius veins). The crude reporting rate was ~20.7 cases of TEE per 100 000 doses of Ad.26.COV2.S administered.
Life-threatening or fatal TEEs have been reported after Ad.26.COV2.S, including bilateral massive pulmonary embolism or other severe clot burden.
美国食品和药物管理局（FDA）已经确定了 Ad.26.COV2.S COVID-19 疫苗接种后血栓栓塞事件（TEE）的潜在安全隐患。我们试图描述 Ad.26.COV2.S 后向疫苗不良事件报告系统（VAERS）报告的 TEE 的频率、严重程度、类型和解剖部位。
在 VAERS 中确定 Ad.26.COV2.S 后 TEE 的报告，并总结人口统计学、临床特征和相关病史。对于一部分报告，医生查阅了可用的病历，并评估了临床表现、诊断评估、危险因素和治疗方法。根据 VAERS 中的病例数和疫苗接种数据，估计 TEE 的粗报告率。
截至 2022 年 2 月 28 日，FDA 确定了 3790 例 Ad.26.COV2.S 后 TEE 的报告。中位年龄为 56 岁，1938 人（51.1%）为女性。大多数报告（2892 例，76.3%）为严重报告，包括 421 例死亡。中位发病时间为接种疫苗后 12 天。肥胖和缺血是最常见的记录危险因素。血小板减少症（血小板计数<150000/μl）在 63 份记录中记录（11.5%），抗血小板 4 抗体在 25 份记录中记录（4.6%）。医学审查发现了严重血栓负荷的病例（例如，双侧、鞍状或其他巨大肺栓塞伴或不伴肺心病；下肢血栓累及髂外、股总、腘、胫后、腓和比目鱼肌静脉）。粗报告率约为每 100000 剂 Ad.26.COV2.S 接种后发生 20.7 例 TEE。
Ad.26.COV2.S 接种后发生了危及生命或致命的 TEE，包括双侧巨大肺栓塞或其他严重血栓负荷。
