CDC & FDA ‘Pause’ Johnson & Johnson Vaccine Over Blood Clots

The United States Food and Drug Administration along with the Centers for Disease Control and Prevention have announced a “pause” on the administration of Johnson & Johnson’s COVID-19 vaccine because of blood clots that occurred in several women shortly after they received their inoculations.

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“We are recommending a pause in the use of this vaccine out of an abundance of caution. As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare,” the FDA tweeted early Tuesday morning.

“Treatment of this specific type of blood clot is different from the treatment that might typically be administered. CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases,” the agency said.

“Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot,” the FDA added.

“COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” the thread concluded.

Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said in a joint statement that “in these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.”

Symptoms include a “stroke-like illness,” Schuchat explained. “I know that the information we are providing today will be very concerning to Americans who already received the Johnson & Johnson or Janseen vaccine.”

Schuchat recommended that individuals who received the Johnson & Johnson vaccine remain on the lookout for severe headache, abdominal pain, leg pain, or shortness of breath for up to three weeks. Patients should contact their health care provider if any or all of those conditions appear.

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