FDA, CDC Recommend Pausing Johnson & Johnson Vaccine Due To ‘Extremely Rare’ Clots

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention called for a pause Tuesday in the use of Johnson & Johnson’s coronavirus vaccine “out of an abundance of caution” due to an “extremely rare” incidence of blood clots.

Six recipients in the U.S. developed a rare disorder involving blood clots about two weeks after vaccination, The New York Times reported. More than 6.8 million doses of the vaccine have been administered in the U.S.

In a joint statement, the FDA and CDC said “a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).” All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after they received the shot.

The organizations are recommending the pause so that the CDC can convene an advisory committee on Wednesday and the FDA can investigate the cases. They want to ensure that health care providers can plan for the unique treatment required with this type of blood clot.

They ask that people who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks of receiving the shot contact their health care provider. 

The U.S. pause comes shortly after European authorities said they were investigating cases of the unusual blood clots. In response to those reports, a J&J spokesperson said: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with all COVID-19 vaccines. Our close tracking of side effects has revealed a small number of very rare events following vaccination.

“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”

Vaccine hesitancy is an issue both in the U.S. and worldwide. The vaccine developed by AstraZeneca and Oxford University has come against similar issues and has been variously paused and suspended in different age groups in Europe. 

This is a developing story. Please check back for updates.

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