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Joint CDC and FDA Assertion on Johnson & Johnson COVID-19 Vaccine | CDC On-line Newsroom

As of April 12, greater than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered within the U.S. CDC and FDA are reviewing information involving six reported U.S. circumstances of a uncommon and extreme kind of blood clot in people after receiving the J&J vaccine. In these circumstances, a sort of blood clot referred to as cerebral venous sinus thrombosis (CVST) was seen together with low ranges of blood platelets (thrombocytopenia). All six circumstances occurred amongst girls between the ages of 18 and 48, and signs occurred 6 to 13 days after vaccination. Therapy of this particular kind of blood clot is totally different from the therapy that may sometimes be administered. Often, an anticoagulant drug referred to as heparin is used to deal with blood clots. On this setting, administration of heparin could also be harmful, and different remedies must be given.

CDC will convene a gathering of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to additional assessment these circumstances and assess their potential significance. FDA will assessment that evaluation because it additionally investigates these circumstances. Till that course of is full, we’re recommending a pause in using this vaccine out of an abundance of warning. That is essential, partially, to make sure that the well being care supplier group is conscious of the potential for these adversarial occasions and might plan for correct recognition and administration because of the distinctive therapy required with any such blood clot.

Proper now, these adversarial occasions seem like extraordinarily uncommon. COVID-19 vaccine security is a prime precedence for the federal authorities, and we take all experiences of well being issues following COVID-19 vaccination very severely. Individuals who have obtained the J&J vaccine who develop extreme headache, stomach ache, leg ache, or shortness of breath inside three weeks after vaccination ought to contact their well being care supplier. Well being care suppliers are requested to report adversarial occasions to the Vaccine Antagonistic Occasion Reporting System at https://vaers.hhs.gov/reportevent.htmlexterior icon

CDC and FDA will present further info and reply questions later at this time at a media briefing. A recording of that media name will likely be obtainable on the FDA’s YouTube channel.

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