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Assessing a Rare and Serious Adverse Event Following Administration of the Ad26.COV2.S Vaccine

Assessing a Rare and Serious Adverse Event Following Administration of the Ad26.COV2.S Vaccine Opinion EDITORIAL Assessing a Rare and Serious Adverse Event Following Administration of the Ad26.COV2.S Vaccine Ruth A. Karron, MD; Nigel S. Key, MD; Joshua M. Sharfstein, MD In this issue of JAMA, See and colleagues present a case adenovirus-vectored vaccines. Missing epidemiologic infor- series of patients with cerebral venous sinus thrombosis mation includes more accurate estimates of the frequency of the syndrome and the full spectrum of thrombotic (CVST) following vaccination with the Ad26.COV2.S vaccine manufactured by Janssen/Johnson & Johnson. These cases complications. The availability of an interim standardized were identified through the case definition will facilitate prospective case ascertain- Vaccine Adverse Event Re- ment through review of large linked databases and active Related article porting System (VAERS), a case finding. It will also permit greater understanding national vaccine safety surveillance program of the Centers of whether individuals who are otherwise at increased risk for Disease Control and Prevention (CDC) and the Food and for hypercoagulation in general and for CVST in particular Drug Administration (FDA). The 12 patients—all women aged (for example, women taking hormonal contraceptive medi- 18 to 59 years—developed symptoms beginning 6 to 15 days cations or who are pregnant) are also at increased risk for http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Assessing a Rare and Serious Adverse Event Following Administration of the Ad26.COV2.S Vaccine

JAMA , Volume 325 (24) – Jun 22, 2021

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Publisher
American Medical Association
Copyright
Copyright 2021 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2021.7637
Publisher site
See Article on Publisher Site

Abstract

Opinion EDITORIAL Assessing a Rare and Serious Adverse Event Following Administration of the Ad26.COV2.S Vaccine Ruth A. Karron, MD; Nigel S. Key, MD; Joshua M. Sharfstein, MD In this issue of JAMA, See and colleagues present a case adenovirus-vectored vaccines. Missing epidemiologic infor- series of patients with cerebral venous sinus thrombosis mation includes more accurate estimates of the frequency of the syndrome and the full spectrum of thrombotic (CVST) following vaccination with the Ad26.COV2.S vaccine manufactured by Janssen/Johnson & Johnson. These cases complications. The availability of an interim standardized were identified through the case definition will facilitate prospective case ascertain- Vaccine Adverse Event Re- ment through review of large linked databases and active Related article porting System (VAERS), a case finding. It will also permit greater understanding national vaccine safety surveillance program of the Centers of whether individuals who are otherwise at increased risk for Disease Control and Prevention (CDC) and the Food and for hypercoagulation in general and for CVST in particular Drug Administration (FDA). The 12 patients—all women aged (for example, women taking hormonal contraceptive medi- 18 to 59 years—developed symptoms beginning 6 to 15 days cations or who are pregnant) are also at increased risk for

Journal

JAMAAmerican Medical Association

Published: Jun 22, 2021

References

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