J&J listed blood clots and death at the onset. How were blood clots and death not anticipated?
The FDA didn’t recommend the pause “because we felt that the number of cases was growing out of control, but because we wanted to educate providers to know what to do,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, during an
AMA-hosted webinar.
This also includes informing doctors that standard treatments—such as administering heparin—can worsen a patient’s condition.
“One of the individuals who received heparin clearly had complications related to the receipt of heparin,” Dr. Marks told AMA President
Susan R. Bailey, MD, in the seventh installment of the AMA-hosted "
COVID-19: What Physicians Need to Know" webinar series to discuss current issues and next steps in SARS-CoV-2 vaccine safety and delivery.
Nearly 7 million doses of the J&J vaccine have been administered, but the FDA and Centers for Disease Control and Prevention (CDC) are reviewing data involving six reported cases in the U.S. of a brain blood clot—cerebral venous sinus thrombosis in combination with thrombocytopenia—in people getting the J&J vaccine. All were in women between 18 and 48, with symptoms developing six to 13 days after vaccination.
One of the women died. Another is hospitalized in critical condition.
The pause also gives the FDA and CDC time to ascertain whether there are other cases that the agencies were not aware of, whether women 18–48 are at higher relative risk for blood clots after receiving the vaccine and, if so, develop appropriate mitigation strategies.
J&J vaccine and brain blood clots: What physicians should know