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

As of April 12, extra than six.eight million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and Food and drug administration are reviewing knowledge involving six claimed U.S. cases of a uncommon and extreme type of blood clot in people today soon after obtaining the J&J vaccine. In these cases, a type of blood clot known as cerebral venous sinus thrombosis (CVST) was witnessed in mix with reduced stages of blood platelets (thrombocytopenia). All six cases happened amid women involving the ages of 18 and 48, and signs happened six to thirteen times soon after vaccination. Procedure of this distinct type of blood clot is distinctive from the remedy that might commonly be administered. Usually, an anticoagulant drug known as heparin is made use of to address blood clots. In this environment, administration of heparin may perhaps be risky, and alternate therapies need to be supplied.

CDC will convene a conference of the Advisory Committee on Immunization Procedures (ACIP) on Wednesday to even further overview these cases and assess their opportunity significance. Food and drug administration will overview that examination as it also investigates these cases. Right until that process is comprehensive, we are recommending a pause in the use of this vaccine out of an abundance of warning. This is important, in portion, to make sure that the well being care provider community is mindful of the opportunity for these adverse activities and can approach for right recognition and administration owing to the special remedy expected with this type of blood clot.

Ideal now, these adverse activities appear to be extremely uncommon. COVID-19 vaccine basic safety is a leading priority for the federal governing administration, and we take all experiences of well being challenges next COVID-19 vaccination extremely critically. Folks who have been given the J&J vaccine who establish extreme headache, stomach ache, leg ache, or shortness of breath within just three months soon after vaccination should really make contact with their well being care provider. Health and fitness care companies are requested to report adverse activities to the Vaccine Adverse Function Reporting Process at https://vaers.hhs.gov/reportevent.htmlexterior icon

CDC and Food and drug administration will deliver added information and facts and response thoughts later on currently at a media briefing. A recording of that media call will be readily available on the FDA’s YouTube channel.