On Monday, the FDA and the CDC issued a joint statement on Johnson and Johnson COVID-19 vaccine recommending a pause in the drug’s use due to six cases of reported blood clots in patients.
The CDC and FDA are currently reviewing the data saying the reported incidents are a rare and severe type of blood clot called a cerebral venous sinus thrombosis or CVST. All six cases occurred six to thirteen days after receiving the vaccination, and all incidents occurred in women between the ages of 18 and 48.
The CDC is set to convene a meeting of the Advisory Committee on Immunization practices to review the cases further. The FDA will review the data as it investigates the instances of blood clots in patients. At this time, both the FDA and the CDC recommend a “pause” in the use of the Johnson and Johnson (Janssen) vaccine out of caution. Both organizations agree that proper planning in recognizing and managing any such cases, including treatment, is essential.
The FDA says that the adverse effects appear to be extremely rare. People who have received the Johnson and Johnson vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System.