Johnson & Johnson COVID-19 vial and box seen at the vaccination site. Doses of the Johnson & Johnson vaccine are given throughout the state of Florida, despite a small number of patients who have experienced side effects, including blood clots.
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The Food and Drug Administration said on Tuesday it was calling on states to temporarily stop using Johnson & Johnson’s Covid-19 vaccine after six people in the United States developed a rare blood clotting disorder.
The FDA said the recommendation was “out of an abundance of caution.”
“At this time, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “The safety of the COVID-19 vaccine is a top priority for the federal government, and we take all reports of COVID-19 vaccination very seriously.”
All six cases occurred in women between the ages of 18 and 48, with symptoms occurring six to 13 days after receiving the shot. Doctors usually treat that type of blood clot with heparin, but health regulators have noticed that it could be dangerous in this case and have recommended a different treatment.
People who receive the vaccine and “develop severe headaches, abdominal pain, leg pain, or difficulty breathing within three weeks of vaccination should contact their healthcare provider,” the FDA and CDC said.
Shares of J&J fell more than 3% in premarket trading on Tuesday.
The CDC will convene a meeting of the Immunization Practices Advisory Committee on Wednesday to further review the cases, federal health regulators said Tuesday. The FDA is also investigating the cases.
When J&J submitted its Covid vaccine data to the FDA in February, no specific concerns were identified when analyzed by age, race and comorbidities, according to the agency. The FDA said at the time that the most common side effects reported were headache and fatigue, followed by muscle aches, nausea and fever.
The New York Times first reported the news.
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