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
JAMA – American Medical Association
Published: Jun 22, 2021
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