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Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine | CDC Online Newsroom

As of April twelve, much more than six.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and Fda are reviewing details involving 6 reported U.S. scenarios of a exceptional and extreme type of blood clot in folks just after acquiring the J&J vaccine. In these scenarios, a type of blood clot referred to as cerebral venous sinus thrombosis (CVST) was found in blend with low concentrations of blood platelets (thrombocytopenia). All 6 scenarios transpired amongst gals among the ages of 18 and 48, and signs transpired six to 13 days just after vaccination. Treatment of this certain type of blood clot is various from the therapy that could usually be administered. Generally, an anticoagulant drug referred to as heparin is employed to take care of blood clots. In this placing, administration of heparin may perhaps be risky, and option treatment plans require to be specified.

CDC will convene a assembly of the Advisory Committee on Immunization Techniques (ACIP) on Wednesday to even further overview these scenarios and evaluate their opportunity importance. Fda will overview that assessment as it also investigates these scenarios. Until that approach is total, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is vital, in component, to guarantee that the overall health care provider community is conscious of the opportunity for these adverse activities and can approach for correct recognition and administration due to the special therapy required with this type of blood clot.

Proper now, these adverse activities surface to be incredibly exceptional. COVID-19 vaccine basic safety is a leading priority for the federal federal government, and we take all reports of overall health complications subsequent COVID-19 vaccination very severely. People today who have acquired the J&J vaccine who produce extreme headache, abdominal pain, leg pain, or shortness of breath within just a few weeks just after vaccination ought to get hold of their overall health care provider. Overall health care vendors are questioned to report adverse activities to the Vaccine Adverse Event Reporting System at icon

CDC and Fda will offer more info and response thoughts later these days at a media briefing. A recording of that media get in touch with will be out there on the FDA’s YouTube channel.