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Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021.
Morbidity and Mortality Weekly Report ( IF 33.9 ) Pub Date : 2021-04-30 , DOI: 10.15585/mmwr.mm7017e4
Jessica R. MacNeil , John R. Su , Karen R. Broder , Alice Y. Guh , Julia W. Gargano , Megan Wallace , Stephen C. Hadler , Heather M. Scobie , Amy E. Blain , Danielle Moulia , Matthew F. Daley , Veronica V. McNally , José R. Romero , H. Keipp Talbot , Grace M. Lee , Beth P. Bell , Sara E. Oliver

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen COVID-19 vaccine after reports of six U.S. cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare thromboembolic syndrome, among Janssen COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of thrombosis with thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons aged ≥18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. Patient and provider education about the risk for TTS with the Janssen COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative COVID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS.

中文翻译:

美国詹森(Johnson&Johnson)COVID-19疫苗免疫实践咨询委员会的更新建议,据报道,接受者中有血小板减少综合征的血栓形成发生于2021年4月,美国。

2021年2月27日,美国食品药品监督管理局(FDA)发出了Janssen COVID-19(Ad.26.COV2.S)疫苗的紧急使用授权(EUA)(Janssen Biotech,Inc.,Janssen Pharmaceutical公司,强生公司(Johnson&Johnson),新泽西州新不伦瑞克省(New Brunswick,New Jersey)以及2021年2月28日,免疫实践咨询委员会(ACIP)发布了针对18岁以上人群使用的临时建议(1,2)。2021年4月13日,美国疾病预防控制中心(CDC)和美国食品和药物管理局(FDA)建议在詹森(Janssen)COVID-19疫苗中有6例美国病例发生血小板减少症(一种罕见的血栓栓塞综合征)的美国脑静脉窦血栓形成(CVST)案例后,暂停使用詹森COVID-19疫苗。收件人(3)。快速召开了两次紧急ACIP会议,以审查报告的血小板减少综合征(TTS)血栓形成病例,并考虑在美国使用Janssen COVID-19疫苗的最新建议。2021年4月23日,在讨论了恢复接种疫苗的好处和风险之后,ACIP重申了其临时建议,即根据FDA的EUA在所有18岁以上的人群中使用Janssen COVID-19疫苗,该建议现在包括以下警告:接种疫苗后可能会发生罕见的凝血事件,主要发生在18-49岁的女性中。对患者和提供者进行有关使用Janssen COVID-19疫苗进行TTS风险的教育,尤其是对于年龄小于50岁的女性,以及是否有替代的COVID-19疫苗,
更新日期:2021-04-30
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