FDA temporarily suspends Johnson & Johnson vaccine due to rare blood clotting problems

Johnson & Johnson COVID-19 vial and box seen at a vaccination site. Doses of the Johnson & Johnson vaccine are administered throughout the state of Florida, despite a small number of patients who have experienced adverse reactions, including blood clots.

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The Food and Drug Administration said Tuesday it is asking states to temporarily halt the use of Johnson & Johnson’s Covid-19 vaccine after six people in the U.S. developed a rare blood clotting disorder.

The FDA said the recommendation was “out of an abundance of caution”, and adding the adverse events seen in the handful of recipients appears to be extremely rare.

“The safety of COVID-19 vaccines is a top priority for the federal government, and we take all reports of health problems after COVID-19 vaccination very seriously,” the FDA said in a joint statement with the Centers for Disease Control. and Prevention said.

“People who have received the J&J vaccine that develops severe headaches, abdominal pain, leg pain or shortness of breath within three weeks of vaccination should contact their healthcare provider,” the FDA and CDC said.

The New York Times first reported the news. Shares of J&J fell more than 3% on Tuesday.

The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review matters, federal health regulators said Tuesday.

When J&J submitted its Covid vaccine data to the FDA in February, according to the agency, no specific problems were identified when analyzed according to age, race and comorbidities. The FDA said at the time that the most common side effects are headaches and fatigue, followed by muscle aches, nausea and fever.

This is news. Check back for updates.

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