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Janssen COVID-19 Vaccine Frequently Asked Questions - FDA

Mary Wilson

Well-known member
04/14/2021

On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

... The FDA and CDC are reviewing data involving six cases reported to the Vaccine Adverse Event Reporting System (VAERS) of a low level of platelets in the blood in combination with a rare and severe type of blood clot called cerebral venous sinus thrombosis (CVST) in individuals who had received the Janssen COVID-19 Vaccine. One individual died. All cases occurred in females ranging in age from 18 through 48 years. In some of the reported cases of CVST, blood clots also involved large veins in the abdomen.

Out of an abundance of caution, the FDA and CDC are recommending a pause in the use of the Janssen COVID-19 Vaccine while the FDA and CDC, including through its Advisory Committee on Immunization Practices investigate these reports of serious adverse events.

https://www.fda.gov/emergency-prepa...n-covid-19-vaccine-frequently-asked-questions
 
Report: Person in Nevada with serious side effects to Johnson & Johnson COVID-19 vaccine - Janssen

Posted at 1:50 PM, Apr 14, 2021
and last updated 7:31 PM, Apr 14, 2021

CARSON CITY (KTNV) ? During Wednesday?s public federal Advisory Committee on Immunization Practices (ACIP) meeting, the Nevada Department of Health and Human Services says it learned that a Nevadan was one of the six reported serious reactions to the Johnson & Johnson (Janssen) COVID-19 vaccine.

The state of Nevada was not informed of this reported reaction until the live, public meeting on Wednesday, according to the Nevada Health Response team.

On Tuesday, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued a joint statementrecommending a pause in the use of the Janssen COVID-19 vaccine while six serious reactions were investigated.

... As of Monday, more than 6.8 million doses of the Janssen vaccine have been administered in the United States.

https://www.ktnv.com/news/coronaviru...rted-in-nevada
 
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