J&J Pause Over Blood-Clots To Educate Doctors, Study Cases: US Regulator

That's the message from Peter Marks, a top official at the U.S. Food and Drug Administration, after six women between the ages of 18 and 48 developed severe blood clots in the brain days after getting the one-shot vaccine and federal officials called for a temporary halt in its use.

U.S. health officials urged a pause on the use of Johnson & Johnson's Covid-19 vaccine due to dangerous blood-clotting to give them time to educate doctors on how to treat the exceedingly rare disorder and to "look in all the nooks and crannies" for other cases. That's the message from Peter Marks, a top official at the U.S. Food and Drug Administration, after six women between the ages of 18 and 48 developed severe blood clots in the brain days after getting the one-shot vaccine and federal officials called for a temporary halt in its use. J&J decided to delay rollout of the immunization in Europe and pause all of its Covid-19 vaccine trials. At least one woman died, and a second was in critical condition, out of almost 7 million Americans who received the shot as of Monday, officials said. The normal treatment for clots, the blood-thinner heparin, could make the disorder worse, or even kill a patient, health officials said Tuesday. "Everyone knew it could cause a hit to vaccine confidence," said Marks, the head of the FDA's Center for Biologics Evaluation and Research, speaking Tuesday at an American Medical Association webinar. Though the cases "could just be a statistical aberration," the health authorities sought to exercise an abundance of caution, he said.