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

As of April twelve, more than six.eight million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and Fda are examining info involving six noted U.S. instances of a exceptional and serious form of blood clot in individuals soon after acquiring the J&J vaccine. In these instances, a form of blood clot identified as cerebral venous sinus thrombosis (CVST) was viewed in mix with reduced concentrations of blood platelets (thrombocytopenia). All six instances occurred among the females in between the ages of 18 and forty eight, and indications occurred six to thirteen times soon after vaccination. Cure of this distinct form of blood clot is distinctive from the procedure that could usually be administered. Usually, an anticoagulant drug identified as heparin is made use of to address blood clots. In this placing, administration of heparin may be hazardous, and different solutions need to have to be supplied.

CDC will convene a meeting of the Advisory Committee on Immunization Techniques (ACIP) on Wednesday to more review these instances and assess their prospective significance. Fda will review that analysis as it also investigates these instances. Right until that system is finish, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is essential, in component, to make certain that the wellness care company local community is mindful of the prospective for these adverse gatherings and can system for good recognition and administration owing to the one of a kind procedure expected with this form of blood clot.

Right now, these adverse gatherings seem to be particularly exceptional. COVID-19 vaccine safety is a best priority for the federal government, and we consider all experiences of wellness problems following COVID-19 vaccination really critically. Persons who have received the J&J vaccine who acquire serious headache, belly ache, leg ache, or shortness of breath within a few months soon after vaccination should really make contact with their wellness care company. Wellness care suppliers are questioned to report adverse gatherings to the Vaccine Adverse Occasion Reporting Process at icon

CDC and Fda will offer supplemental info and solution queries later nowadays at a media briefing. A recording of that media phone will be offered on the FDA’s YouTube channel.