FDA temporarily stops use of Johnson & Johnson vaccine due to rare blood clotting problems

The Food and Drug Administration said Tuesday it is asking states to temporarily stop using the Johnson & Johnson Covid-19 vaccine after six people in the United States developed a rare blood clotting disorder.

The FDA said the recommendation is “very cautious,” adding that adverse events seen in a handful of recipients appear to be extremely rare.

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

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

All six cases occurred in women between the ages of 18 and 48, with symptoms that developed six to 13 days after receiving the vaccine. Doctors usually treat this type of blood clot with heparin, but health regulators noted that in this case they could be dangerous and recommended a different treatment.

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

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

When J&J submitted Covid vaccine data to the FDA in February, no specific concerns were identified when analyzed for 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.

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