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 that it will temporarily halt use of the Johnson & Johnson COVID-19 vaccine at the urging of the federal government.
Dr. Mandy Cohen, the DHHS secretary, said department staff learned Tuesday morning that the Centers for Disease Control and Prevention and Food and Drug Administration were calling for federal vaccine sites to stop using the Johnson & Johnson vaccine at their sites and recommending that other providers do the same.
“Our primary concern is the health and safety of all North Carolinians, therefore we are following those recommendations of the FDA and CDC and have asked our vaccinating providers to pause the administration of the J&J COVID-19 vaccine until we learn more,” Cohen said during a Tuesday press conference.
Nationwide, there have been six cases in which women between the ages of 18 and 48 have developed what CDC and FDA officials 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. It is also referred to as the Janssen vaccine, as Janssen is the J&J subsidiary that produces it.
“Right now, these adverse events appear to be extremely rare,” the CDC and FDA said in a joint press release. “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.”
Why is the pause happening?
Dr. Janet Woodcock, the acting FDA commissioner, said during a news conference that while it is not possible to say how long the Johnson & Johnson “pause” will last, federal officials “expect it to be a matter of days.”
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 the FDA 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.
There have been no reports of similar incidents among people who took the Moderna or Pfizer vaccines.
“Our vaccine safety system is working,” Cohen said, adding that the government’s ability to identify a half-dozen incidents like the ones that caused the Johnson & Johnson pause should give the public additional faith in the safety of the Moderna and Pfizer shots.
The discovery of six people with serious side effects out of 7 million doses of the Johnson & Johnson vaccine administered so far should be reassuring, said Dr. David Wohl, an infectious disease specialist at UNC Health in Chapel Hill.
“The events of the last day really reflect the vigilance that we have in our system,” Wohl said Tuesday. “We have a safety net for reasons. There’s scrutiny and monitoring for adverse events. And the system is working for us.”
Johnson & Johnson in North Carolina
North Carolina’s vaccine providers could continue using the Johnson & Johnson shot, said Cohen, but the state health department’s stance was a “strong recommendation” to pause in line with the FDA and CDC.
“Our vaccine providers do have the wiggle room to decide that they want to keep vaccinating,” Cohen said. “We are asking folks to pause as we understand this better in the moment, and we will learn more over the next couple of days.”
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. About 250 patients were scheduled to receive J&J vaccines Tuesday at UNC Health clinics at the Friday Center in Chapel Hill, in Hillsborough and at Panther Creek in Cary.
Clinics at N.C. State University and the University of North Carolina-Chapel Hill also stopped administering the vaccine.
“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 written 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.
Anyone who was set to receive a Johnson & Johnson vaccine from Durham Public Health should still come to their appointment and will receive either the Moderna or Pfizer vaccine, according to a department spokesperson.
North Carolina is set to receive 17,700 doses of the Johnson & Johnson vaccine this week, according to CDC records, down from 149,800 doses last week. The steep decline was expected and is in part caused by the halt at a Baltimore plant where mistakes in production ruined an estimated 15 million doses of the vaccine.
The Merck vaccine manufacturing plant in Durham is scheduled to begin producing part of the Johnson & Johnson vaccine in May, but a Food and Drug Administration whistleblower has raised concerns about hygiene practices at that plant.
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 requires only 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.
COVID vaccines have saved lives, doctors say
Wohl at UNC and Dr. Cameron Wolfe, an infectious disease specialist at Duke Health, said the CDC and FDA will need to determine whether the serious but apparently rare side effect with the Johnston & Johnston vaccine can be managed in a way that allows the vaccine to be used.
“We have people who react seriously to penicillin. We don’t throw away penicillin,” Wohl said. “Penicillin is very, very useful. It saves lives, even though some people can get a reaction to penicillin.”
Both Wohl and Wolfe noted that blood clots are also one symptom of COVID-19, which all three vaccines have proven to prevent. Wolfe said one or two over every 100 COVID-19 patients hospitalized at Duke developed blood clots at some point, compared to one in a million who received the Johnson & Johnson vaccine.
More than 120 million Americans have received at least one dose of COVID-19 vaccine so far, with minor if any side effects. Both Wohl and Wolfe said it would be unfortunate if the pause in administering the Johnson & Johnson vaccine made people hesitant to get either the Pfizer or Moderna.
“We have averted tens of thousands of deaths already because of what we’ve done,” Wolfe said. “And whilst this is important, this should not be a pause in those other ones. Quite the opposite.”
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.
This story was originally published April 13, 2021 at 9:35 AM.