FDA, CDC recommend pausing use of Johnson & Johnson vaccine after reports of rare but severe blood clots
The Food and Drug Administration and the Centers for Disease Control and Prevention are recommending the U.S. pause on using the Johnson & Johnson COVID-19 vaccine after reports of blood clots in individuals who received the vaccine.
The health agencies released a statement Tuesday morning recommending the pause “out of an abundance of caution,” saying blood clots still seem to be “extremely rare.” So far, the CDC and FDA are reviewing six reported cases in the U.S.
All six recipients were women between the ages of 18 and 48, with symptoms occurring 6 to 13 days after vaccination, according to the statement. One woman died and one has been hospitalized in critical condition, the New York Times reported.
The CDC’s Advisory Committee on Immunization Practices (ACIP) will hold a meeting Wednesday to analyze the cases. The FDA said it will review the committee’s analysis as it also investigates the cases.
“Until that process is complete, we are recommending this pause,” Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a joint statement. “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 type of blood clot reported in individuals who have received the J&J vaccine is called cerebral venous sinus thrombosis (CVST). In most clinical settings, an anticoagulant drug called herapin is usually administered to treat blood clots. However, health officials say using this drug could be dangerous and recommend alternative treatments.
A news conference is scheduled for 10 a.m. As of April 12, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S. and approximately 9 million more has been shipped out to states, according to the CDC.
“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,” said Schuchat and Marks.
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People who have received the J&J vaccine and develop a severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider, health officials recommended.
The pause could complicate the country’s vaccination rollout plans, especially after Biden administration moved up the deadline to make all adults eligible for a COVID-19 vaccine from May 1 to April 19.
The J&J vaccine received emergency use authorization from the FDA in late February. The company had promised 100 million single-shot doses to the U.S. government by the end of May.
Follow Adrianna Rodriguez: @AdriannaUSAT.
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