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

As of April 12, extra than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and Fda are examining data involving 6 described U.S. instances of a unusual and serious form of blood clot in people immediately after acquiring the J&J vaccine. In these cases, a variety of blood clot identified as cerebral venous sinus thrombosis (CVST) was observed in blend with very low ranges of blood platelets (thrombocytopenia). All six cases happened amid females among the ages of 18 and 48, and signs or symptoms occurred 6 to 13 times soon after vaccination. Treatment method of this particular sort of blood clot is different from the remedy that could generally be administered. Usually, an anticoagulant drug known as heparin is used to treat blood clots. In this location, administration of heparin could be unsafe, and alternative treatment options have to have to be offered.

CDC will convene a meeting of the Advisory Committee on Immunization Methods (ACIP) on Wednesday to even further overview these instances and evaluate their probable significance. Fda will review that analysis as it also investigates these situations. Until eventually that approach is finish, we are recommending a pause in the use of this vaccine out of an abundance of warning. This is important, in section, to ensure that the health care provider group is informed of the probable for these adverse functions and can plan for proper recognition and administration due to the exclusive remedy essential with this sort of blood clot.

Ideal now, these adverse occasions surface to be incredibly scarce. COVID-19 vaccine safety is a best priority for the federal govt, and we just take all reports of health and fitness challenges next COVID-19 vaccination very severely. Men and women who have acquired the J&J vaccine who establish extreme headache, abdominal suffering, leg discomfort, or shortness of breath within a few months soon after vaccination should really get hold of their overall health care supplier. Well being treatment providers are questioned to report adverse gatherings to the Vaccine Adverse Function Reporting Program at https://vaers.hhs.gov/reportevent.htmlexternal icon.

CDC and Food and drug administration will offer added info and solution thoughts afterwards nowadays at a media briefing. A recording of that media call will be readily available on the FDA’s YouTube channel.