Johnson & Johnson COVID-19 vial and box seen at a vaccination site. Doses of the Johnson & Johnson vaccine are given in the state of Florida despite a small number of patients who have experienced side effects, including blood clots.
Paul Hennessy | LightRocket | Getty images
The Food and Drug Administration said Tuesday it is asking states to temporarily stop using Johnson & Johnson’s Covid-19 vaccine after six people in the US develop a rare blood clotting disorder.
The FDA said the recommendation is “out of a plethora of caution,” and adding the side effects seen in the handful of recipients appears to be extremely rare.
“Right now, these side effects 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 health problems following vaccination with COVID-19 very seriously.”
All six cases occurred in women between the ages of 18 and 48, with symptoms developing six to 13 days after receiving the injection. Doctors usually treat that type of blood clot with heparin, but health regulators noted that it could be dangerous in this case and recommended a different treatment.
People who receive the vaccine who “develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination should contact their healthcare provider,” the FDA and CDC said.
Shares of J&J fell more than 3% on Tuesday during premarket trading.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review the cases, federal health regulators said Tuesday. The FDA is also investigating the cases.
When J&J submitted data from the Covid vaccine to the FDA in February, no specific concerns were identified when analyzed based on age, race, and comorbidity, according to the agency. The FDA said at the time that the most common side effects were headache and fatigue, followed by muscle pain, nausea, and fever.
The New York Times first reported the news.
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