WASHINGTON – The FDA says the pause to the Johnson & Johnson COVID-19 vaccine to investigate rare blood clots is expected to last a “matter of days.”
This is an update to a previous report: FDA recommends pause for Johnson & Johnson COVID vaccine after extremely rare blood clotting cases
The FDA and CDC announced Tuesday morning that they are recommending a pause in the use of the J&J vaccine “out of an abundance of caution.”
The FDA said as of April 12 more than 6.8 million doses of the J&J vaccine have been administered in the U.S. The FDA and CDC are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine. That means the percentage of people who have developed problems from it is only 0.00008% of recipients.
“Right now, these adverse events appear to be extremely rare,” reads the statement from the FDA. “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,” reads the FDA statement. “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 Food and Drug Administration (FDA) approved Johnson & Johnson’s COVID-19 vaccine for an emergency use authorization at the end of February.