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.”
Original Story
WASHINGTON (AP) — The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S.
U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.
