The FDA and CDC recommended use of the Johnson & Johnson vaccine be paused out of an abundance of caution after six recipients reported developing a rare type of blood clot. About 6.8 million doses have been administered in the U.S. Credit: Michael Mancuso/NJ Advance Med via TNS
As a precautionary measure, the Wexner Medical Center at Ohio State has halted all Johnson & Johnson COVID-19 vaccine appointments following federal recommendations to pause its use over six reported cases of a rare and severe type of blood clot.
The six cases were among 6.8 million doses administered in the United States as of Monday. According to a statement from the Centers for Disease Control and Prevention and U.S. Food and Drug Administration, all six cases occurred among women between the ages of 18 and 48, with symptoms occurring six to 13 days after vaccination. The six cases account for fewer than one in every million U.S. doses administered.
The CDC and FDA advise anyone who was vaccinated and develops “severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination,” to immediately contact their health care provider.
Gov. Mike DeWine, Director of the Ohio Department of Health Stephanie McCloud and the state’s Chief Medical Officer Dr. Bruce Vanderhoff have asked all Ohio vaccine providers to temporarily stop their use of the vaccine.
The pause comes during Ohio’s prioritization of vaccinating every college student before they travel home at the end of their semesters. The plan relies heavily on the single dose Johnson & Johnson vaccine being administered on college campuses.
On Monday, the Wexner Medical Center began allocating 25 percent of it’s vaccine allotment to Ohio State students, faculty and staff.
In a statement Tuesday, Johnson & Johnson said that “no causal relationship” has been found between the vaccine and the blood clots, and that it is cooperating with the investigation.
The vaccine, like Moderna’s and Pfizer’s, received emergency use authorization by the Food and Drug Administration Feb. 27 to start distributing doses across the U.S. An emergency use authorization grants clearance for use based on two months of safety data, pending a second submission for full approval, which typically takes six months.
In all six cases, patients developed cerebral venous sinus thrombosis, which are blood clots in the sinuses that drain blood from the brain. In a joint statement Tuesday, the FDA and CDC said the pause will allow health care providers to prepare to treat these blood clots, which cannot be treated using typical blood clot medications.
The FDA and CDC said these reactions to the vaccine appear to be “extremely rare.”
“COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccinations very seriously,” the statement reads.
The CDC’s Advisory Committee on Immunization Practices will meet Wednesday to review the cases, according to the statement. The FDA is investigating the cases as well.
