MMWR Morb Mortal Wkly Rep. 2022 Jan 21;71(3):90-95. doi: 10.15585/mmwr.mm7103a4.
On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.
2021 年 2 月 27 日，美国食品和药物管理局（FDA）发布了腺病毒载体 COVID-19 疫苗（杨森生物技术公司，杨森制药公司，强生公司）的紧急使用授权（EUA），并于 2021 年 2 月 28 日，免疫实践咨询委员会（ACIP）发布了一项临时建议，将其作为单剂量主要疫苗接种在 18 岁及以上人群中使用（1，2）。2021 年 4 月 13 日，在报告接种 Janssen COVID-19 疫苗后出现血栓性血小板减少综合征（TTS）后，CDC 和 FDA 建议暂停使用 Janssen COVID-19 疫苗，TTS 是一种罕见的疾病，其特征是血小板减少和血栓形成，包括在不寻常的部位，如脑静脉窦（脑静脉窦血栓形成[CVST]）。*ACIP 迅速召开了两次紧急会议，以审查报告的 TTS 病例，在暂停接种疫苗 10 天后，ACIP 再次确认了其在 18 岁及以上人群中使用 Janssen COVID-19 疫苗的临时建议，但包括接种疫苗后罕见的血栓形成事件的警告，主要发生在 18-49 岁的女性中（3）。2021 年 7 月，在对包括吉兰-巴雷综合征（GBS）和 TTS 风险在内的更新的获益-风险评估进行审查后，ACIP 得出结论，接种 Janssen COVID-19 疫苗的获益超过风险。通过持续的安全性监测和对疫苗不良事件报告系统（VAERS）报告的审查，在接种 Janssen COVID-19 疫苗后又发现了更多的 TTS 病例，包括死亡病例。2021 年 12 月 16 日，ACIP 召开紧急会议，审查 TTS 的最新数据和更新的获益-风险评估。在那次会议上，ACIP 建议优先使用 mRNA COVID-19 疫苗，而不是 Janssen COVID-19 疫苗，包括预防 COVID-19 的所有 18 岁及以上人群的初级和加强剂量。在某些情况下，可以考虑使用 Janssen COVID-19 疫苗，包括对 mRNA COVID-19 疫苗有禁忌的人群。
