CDC and FDA have recommended a pause in the use of the Johnson & Johnson’s Janssen COVID-19 vaccine in the United States out of an abundance of caution, effective Tuesday, April 13, after six cases of a rare but serious blood clot condition in individuals who received the J&J vaccine. CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14, to address this issue. The pause is intended to allow time to prepare healthcare providers to recognize and diagnose patients, treat them appropriately, and report cases that may be related to the vaccine.
As of April 12, 2021, approximately 6.85 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Janssen) have been administered in the United States. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are reviewing data involving six U.S. cases of a rare type of blood clot in individuals after receiving the J&J COVID-19 vaccine that were reported to the Vaccine Adverse Events Reporting System (VAERS). The blood clot was seen in combination with low levels of blood platelets. All six cases occurred in women between the ages of 18-49 and between 6-13 days after
People who have received the J&J/Janssen COVID-19 vaccine within the past three weeks who develop severe headache, abdominal pain, leg pain, or shortness of breath should contact their health care provider.