North Carolina health care providers are being asked to pause use of the Johnson & Johnson COVID-19 vaccine following severe reactions in six women — none of them from North Carolina.
Out of an abundance of caution, use of the vaccine will be paused in North Carolina until the Food and Drug Administration and Centers for Disease Control can complete an investigation and give further advice, said Dr. Mandy Cohen, Secretary of the North Carolina Department of Health and Human Services, in a Tuesday press conference.
“Today’s actions are the result of a vaccine safety system that is working,” Cohen said. “When a problem was identified, even in just six cases, the system was able to let providers know they should pause use of the vaccine for further study. North Carolina is following the FDA and CDC advice.”
The reactions causing the FDA and CDC investigation happened in six women between the ages of 18 and 48. One woman died and another was in critical condition as of Tuesday afternoon.
The women developed a rare type of blood clot, Cohen said, which shouldn’t be treated in the typical way using anti-coagulants or blood thinners like Heparin. The blood-clot condition, known as cerebral venous sinus thrombosis, had combined with low levels of blood platelets in the six cases under scrutiny according to the FDA.
The reaction appears to be so rare as to be “literally one in a million,” Cohen said, with more than six million doses of the Johnson & Johnson vaccine having been administered and just six known cases so far.
“This pause will allow them to look further at the data and make sure providers know how to treat this rare blood clot,” Cohen said.
Those who have appointments to get the Moderna and Pfizer vaccines should keep those appointments, Cohen said. Those who had appointments to get the Johnson & Johnson vaccine will need to reschedule. The state is working to make sure enough vaccine is available for all those who want it.
“COVID-19 vaccines continue to be the most effective way to end this pandemic by preventing the spread of COVID-19, preventing hospitalization and death,” Cohen said. “Our goal is that everyone gets a safe vaccine.”
The vast majority of people who have gotten the Johnson & Johnson vaccine have reported nothing beyond soreness and a bit of fatigue, Cohen said.
“That’s what I experienced when I got the Johnson & Johnson shot,” she said.
Anyone who develops severe headache, abdominal pain, shortness of breath or leg pain within three weeks of receiving the Johnson & Johnson vaccine should report it to their health care provider, Cohen said. But more than 242,000 Johnson & Johnson doses have been given in North Carolina as of Tuesday, Cohen said. So far, no severe reactions have been reported.
“It was clear to us that we needed to alert the public,” said Anne Schuchat, the CDC’s principal deputy director, adding that the pause will allow the health care community to “learn what they needed to learn about how to diagnose, treat and report” on adverse reactions.
A cascade of states — including Virginia, Louisiana and Missouri — said Tuesday following the federal announcement that they would heed the recommendation and halt any administering of the one-shot J&J vaccine.
The J&J vaccine has been viewed as a critical part of ramping up the U.S. vaccination effort, because it requires just one dose and has less-stringent storage requirements.
But so far, it’s been a small share of the overall doses administered — the 6.8 million doses given as of Monday are among nearly 190 million nationally, according to the CDC’s vaccine tracker. Another 9 million have been shipped to states but not yet administered.
In comparison, 98 million doses of the Pfizer vaccine and 85 million of the Moderna vaccine have been administered, both of which require two shots given weeks apart. The rare blood-clot condition has not been reported following doses of those shots.
Johnson & Johnson has faced challenges in scaling up its vaccine production, and had to discard 15 million doses due to errors at a Maryland manufacturing facility.
The federal announcement comes as demand for vaccines is increasing as states remove eligibility requirements, acting on directions from the Biden administration to make every American eligible for a vaccine by Monday.
Jeff Zients, the White House’s COVID-19 response coordinator, said Tuesday that there is enough supply available of Pfizer and Moderna doses to continue the current pace of 3 million shots per day.
He added that the Biden administration is working with states and federally run vaccine sites to reschedule anyone with a J&J appointment to receive one of the other available shots.
It’s not yet clear how long the pause on J&J doses will last. The FDA’s independent vaccine advisory panel, which authorized each of the three current vaccines, is set to meet on Wednesday to review the cases that led to the federal recommendation.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the pause is “a recommendation” and “not a mandate,” adding that federal officials would not stop a provider from administering the vaccine if a provider and a patient determine that the benefits outweigh the risks.
But most Americans are not getting their vaccine directly from a primary-care provider, and instead are going through federally or state-run vaccination sites, or local pharmacies receiving doses through the government.
Leaders of vaccination efforts at UNC Health and Duke Health told reporters Tuesday that the pause in administering the J&J vaccine is proof that there is proper scrutiny and monitoring of possible COVID-19 vaccine side effects.
They did worry that the pause following reports that six women had developed blood clots would sour people on getting vaccinated for COVID.
“The greatest side effect of what we’ll see is more skepticism and more hesitancy,” said Dr. David Wohl, a UNC infectious disease expert who oversees the vaccination effort at the UNC-Chapel Hill Friday Center.
It’s important for vaccination efforts to continue, said Dr. Cameron Wolfe, an infectious disease specialist at Duke.
“Hope what is not the outcome here that people lose faith in the whole process,” Wolfe said. “This is not a call not to vaccinate at all.”
Lynn Bonner and Laura Olson contributed to this report.