North Carolina pauses use of Johnson & Johnson COVID-19 vaccine at CDC, FDA urging

The N.C. Department of Health and Human Services announced Tuesday morning that it will temporarily halt use of the Johnson & Johnson COVID-19 vaccine at the urging of the federal government.

“Out of an abundance of caution, we are following the recommendations of the FDA and CDC and have paused the administration of the Johnson & Johnson COVID-19 vaccine until we learn more. The safety system in place is working as it should,” DHHS said in a prepared statement.

The announcement came hours after the federal government said early Tuesday that it would stop using the Johnson & Johnson vaccine at its sites and recommended that other providers do the same.

Nationwide, there have been six cases where women between the ages of 18 and 48 have developed what officials from the Centers for Disease Control and Prevention and Food and Drug Administration are calling a “rare and severe type of blood clot” shortly after receiving the Johnson & Johnson vaccine. The vaccine has been administered 6.8 million times

“Right now, these adverse events 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 vaccination very seriously,” the CDC and FDA stated in a joint press release Tuesday morning.

The federal halt is happening in part so that officials can help doctors and other health care providers better recognize signs of cerebral venous sinus thrombosis (CVST), the rare blood clot disorder, and know how to help patients. Doctors typically treat blood clots with an anticoagulant drug called heparin, according to the federal agencies, but that course of treatment can be dangerous when a patient has CVST.

“If one administers the standard treatments that we as doctors have learned to give for blood clots, one can actually cause tremendous harm or the outcome can be fatal,” Dr. Peter Marks, the director of the FDA Center for Biologics Evaluation and Research said during a Tuesday morning press conference.

Symptoms of the blood clot disorder can include abdominal pain, leg pain, a severe headache and shortness of breath. The CDC and FDA recommend that anyone who develops any of these within three weeks of receiving the Johnson & Johnson vaccine should contact their healthcare provider.

UNC Health announced that it is pausing the Johnson & Johnson vaccine and offering people another vaccine or the opportunity to reschedule their appointment. The Johnson & Johnson vaccine made up a small number of UNC Health’s shots this week — 85 doses at the Friday Center and 77 at its Hillsborough Hospital clinic.

Clinics at N.C. State University and the University of North Carolina-Chapel Hill announced that they will stop administering the vaccine. UNC’s release said they were doing so at the instruction of the N.C. Department of Health and Human Services, which has not yet publicly taken a stance. Georgia, Mississippi and South Carolina have all halted their use of the Johnson & Johnson vaccine while the federal agencies conduct their review.

“Getting a vaccine remains a critical tool in stopping the spread of COVID-19. The rates of complications after having COVID are exponentially higher than rates of vaccine complications,” Kenneth Pittman, the executive director of UNC’s campus health, said in a prepared statement.

Duke Health announced that it is shifting about 1,800 Johnson & Johnson appointments this week to Moderna or Pfizer, while Charlotte-based Novant Health said it will stop administering the vaccine during the federal pause.

While the Johnson & Johnson vaccine has so far made up a relatively slight portion of the total doses received by North Carolina, it offers some logistical advantages in one of the country’s most rural states.

The Johnson & Johnson vaccine only requires one shot, so people do not have to make a second appointment or worry about getting to one. It also can be stored in a regular refrigerator, unlike the Pfizer vaccine, which some officials had hoped would help with supply in rural areas and doctors’ offices.

Last week, vaccine providers at three North Carolina sites temporarily paused their use of the Johnson & Johnson vaccine because of people having immediate adverse effects. The pauses started with Wake County Public Health, which responded to 18 incidents at its PNC Arena mass vaccination site last Thursday, mostly including dizziness or fainting. A short time later, UNC Health announced that it was pausing its own use of Johnson & Johnson at the Friday Center and Hillsborough Hospital vaccination sites.

A CDC review of the Wake County incidents Thursday evening concluded that there were no “safety issues or reasons for concern” with the vaccine and concluded that the county should keep using the roughly 5,000 doses it still had on hand. UNC Health started using the Johnson & Johnson vaccine again on Saturday while Wake County held an event using that vaccine on Monday.