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

As of April 12, more than 6.eight million doses of the Johnson & Johnson (Janssen

As of April 12, more than 6.eight million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and Food and drug administration are examining information involving six documented U.S. instances of a rare and severe variety of blood clot in people right after obtaining the J&J vaccine. In these instances, a variety of blood clot called cerebral venous sinus thrombosis (CVST) was witnessed in mix with low levels of blood platelets (thrombocytopenia). All six instances transpired amongst women concerning the ages of eighteen and 48, and signs transpired 6 to thirteen times right after vaccination. Therapy of this unique variety of blood clot is distinct from the treatment that could possibly typically be administered. Typically, an anticoagulant drug called heparin is employed to handle blood clots. In this setting, administration of heparin may well be harmful, and option treatments have to have to be provided.

CDC will convene a conference of the Advisory Committee on Immunization Procedures (ACIP) on Wednesday to additional evaluation these instances and evaluate their opportunity importance. Food and drug administration will evaluation that assessment as it also investigates these instances. Until eventually that course of action is finish, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is significant, in aspect, to make sure that the overall health treatment provider neighborhood is knowledgeable of the opportunity for these adverse occasions and can system for proper recognition and administration thanks to the special treatment needed with this variety of blood clot.

Ideal now, these adverse occasions surface to be really rare. COVID-19 vaccine security is a best precedence for the federal government, and we consider all reports of overall health difficulties subsequent COVID-19 vaccination pretty significantly. People today who have been given the J&J vaccine who develop severe headache, stomach discomfort, leg discomfort, or shortness of breath inside three months right after vaccination need to call their overall health treatment provider. Health and fitness treatment providers are questioned to report adverse occasions to the Vaccine Adverse Celebration Reporting Process at icon

CDC and Food and drug administration will deliver additional data and response queries later on today at a media briefing. A recording of that media connect with will be offered on the FDA’s YouTube channel.