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. Read more