NC county pauses use of J&J vaccine after patients have adverse reactions

Wake County said the reactions it observed were "consistent with known common side effects from receiving the vaccine"


There are no safety issues with the Johnson & Johnson COVID-19 vaccine used at Wake County’s PNC Arena mass vaccination site after several adverse reactions were reported, according to an investigation from the Centers for Disease Control and Prevention.

The CDC “did not find any safety issues or reason for concern, and the CDC recommends continuing to administer the vaccine,” the N.C. Department of Health and Human Services reported late Thursday night.

Adam Wagner and Anna Johnson
The News & Observer (Raleigh, N.C.)
        
RALEIGH, N.C. — After 18 people had adverse reactions to the Johnson & Johnson COVID-19 vaccine on Thursday, Wake County Public Health decided to "pause" using the vaccine at its PNC Arena site "out of an abundance of caution," a county spokesperson told The News & Observer.

A couple of hours later, UNC Health's Friday Center and Hillsborough Campus vaccination sites also stopped administering the Johnson & Johnson vaccine. Between five and 10 patients at the Friday Center reported feeling faint and light-headed, according to Dr. David Wohl, a UNC School of Medicine infectious disease physician who helps run the clinic.

The county administered more than 2,300 doses of the Johnson & Johnson vaccine Thursday, according to a press release. Of those who received the shot, the county said, 14 were treated for "minor reactions" on site and four others were taken to area hospitals. Those four people were expected to be treated and released.

In a prepared statement, Kim McDonald, Wake County Public Health's medical director, said, "We know it can be alarming to hear about or see reactions to vaccination — this is why we closely monitor those we vaccinate in case of reaction."

Wake County officials are working with the N.C. Department of Health and Human Services and the Centers for Disease Control and Prevention to investigate Thursday's incident. The CDC is analyzing the vaccine lot, according to the Wake County release, and planned to issue guidance Thursday evening.

"We have not had reports of other increased rates of reactions at any other provider, but will continue to investigate," Catie Armstrong, a health department spokeswoman, wrote in an email to the N&O. "We have notified Johnson & Johnson and are in contact with the federal government."

Thursday's events at PNC Arena and the Friday Center come a day after a similar incident was reported in Colorado. A vaccine clinic in Denver halted operations after 11 people suffered adverse reactions, according to The Denver Post.

The Post said nine of the people who suffered reactions received juice and water, while the two others were taken to a hospital for observation.

Wake County said Thursday that the reactions it observed were "consistent with known common side effects from receiving the vaccine."

Frequent side effects reported in Johnson & Johnson's Phase 3 clinical trials included headaches in about 39% of those receiving the vaccine, fatigue in 38% and muscle aches in 33%. People between 18 and 59 years old were more likely to experience side effects than those over 60, according to the company's application for an Emergency Use Authorization.

J&J vaccine at local hospitals

The Wake County Division of Public Health received 14,200 doses of the Johnson & Johnson vaccine this week, according to DHHS. That made up more than half of the health department's supply of first doses or one-shot vaccines this week, with the department also receiving allocations of 10,530 first doses of the Pfizer-BioNTech vaccine and 3,500 doses of the Moderna vaccine.

The Johnson & Johnson vaccine is given in a single shot while the Moderna and Pfizer vaccines require two doses to reach their full effectiveness.

UNC Health also received a large portion of Johnson & Johnson vaccines this week. The state sent 6,900 doses to UNC Health's Friday Center site and 700 doses to a clinic on the system's Hillsborough campus.

UNC Health has administered 2,200 of those doses, Alan Wolf, a system spokesman, wrote in an email to The News & Observer.

In a phone interview late Thursday afternoon, Wohl said staff at the Friday Center have been observing more people fainting or feeling lightheaded after receiving the Johnson & Johnson vaccine than others.

What remains unclear, Wohl said, is if the potentially higher number of incidents are related to the vaccine itself or if people who dislike shots are more likely to seek out the Johnson & Johnson vaccine.

"We're having a lot of of people who are taking the J&J vaccine because they don't want two shots because they don't like needles," Wohl said.

Wohl said his team is pulling a report from the last two weeks to see if there have been more adverse reactions with the J&J vaccine than the Pfizer or Moderna shots and, if so, to whom it is happening.

If there are patterns, he said, UNC Health sites could alter its procedures, perhaps providing a reclining chair to those with a history of fainting after shots or holding people a little longer if they receive the J&J shot.

"I want to make sure that we suss this out," Wohl said. "Or if we're going to be vaccinating people that are susceptible to fainting, maybe we take different precautions."

Wohl emphasized that the Johnson & Johnson vaccine is a good vaccine and noted that all of the reactions at the Friday Center have been fainting, not more severe allergic reactions. But he also expressed concern that people hearing of Thursday's incidents could become even more anxious about the shot, making themselves more likely to faint or have a similar reaction.

Duke University Hospital received 10,000 doses of the Johnson & Johnson vaccine this week from the same lot as Wake County's doses.

Duke plans to continue using those doses because it has not seen any serious incidents of adverse reactions, Dr. Thomas Owens, the president of Duke University Hospital and senior vice president of the Duke University Health System, wrote in an email.

"Minor side effects from the vaccine have been consistent with those reported by the manufacturer prior to authorization and remain within expected rates. As a result, we do not plan to pause vaccinations at this time and will continue to follow all vaccination policies and guidance from the CDC," Owen wrote in a prepared statement.

Thursday's events at PNC Arena

Daniel Gidlow, who lives in Cary, said he was vaccinated at PNC Arena at 1:30 p.m. Thursday. He was originally scheduled to be observed until 2:10 p.m. but was told to wait for additional monitoring.

"I was just kinda looking around and there was an ambulance that came up to the car behind me and it looked like someone was being hooked up to an IV," he said.

The person from the car behind him was placed on a stretcher and put into the ambulance, he said. Gidlow saw EMTs check the blood pressure of others in nearby cars, but not his. He was able to leave shortly afterward and said he's felt fine since.

Matt Calabria, the chairman of the Wake County Board of Commissioners, said people who were vaccinated at the PNC Arena site without suffering adverse reactions shouldn't be concerned.

"Adverse reactions for the vaccine are typically immediate," Calabria wrote in a text message to The News & Observer. "Less than two hours of appointments were left at PNC Arena. Those remaining appointments are being offered Pfizer vaccines or staff is assisting them in rescheduling."

After receiving the shot at PNC Arena, people drive to a nearby parking lot where they are told to wait for 15 minutes in case adverse reactions come up.

"Our practice of holding vaccine recipients for a short time after injection enabled us to identify and address these reactions quickly," Calabria said.

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