FDA: Short pause of J&J vaccines over clots

Coronavirus

WASHINGTON — The Food and Drug Administration says it expects a short pause of Johnson & Johnson vaccines while regulators investigate reports of potentially dangerous clots in a small number of patients.

Dr. Janet Woodcock, the agency’s acting commissioner, says, “We expect it to be a matter of days for this pause.”

The U.S. FDA and the Center for Disease Control and Prevention recommended the pause Tuesday to investigate unusual clots in six women that occurred 6 to 13 days after vaccination with the J&J vaccine. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All cases were in women between the ages of 18 to 48.

Nearly 7 million J&J doses have been administered in the U.S., almost all without serious side effects.

Regulators say they want to educate patients and medical professionals about spotting and treating the clots. The clots were observed along with reduced platelet counts, making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.”

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