Wake County Greenlights J&J Use after Internal Review Further Confirms Confidence in Vaccine 

Wake County plans to resume administering the Johnson & Johnson COVID-19 vaccine as early as Monday, following a thorough internal review that further supports the findings of the Centers for Disease Control and Prevention and the N.C. Department of Health & Human Services. The findings align with those from other similar events across the country, which indicate no issues of concern.

The FDA is aware of reports of potential adverse events following vaccination with the J&J (Janssen) COVID-19 vaccine at vaccination sites in North Carolina, Iowa, Georgia and Colorado. The symptoms reported included lightheadedness, feeling faint and rapid breathing. We will continue work closely with the CDC, NCDHHS, and Janssen.

Wake County Public Health officials spent time conducting interviews, reviewing vaccine-handling data and reading all patient records available from the 18 people who reported mild to more severe reactions immediately after their shots at PNC Arena yesterday, April 8. The evaluation showed that the only commonality between incidents were that they occurred in the same hour-and-a-half time frame at the outdoor drive-thru clinic. Of the four people who were transported to the hospital, all have been treated and released in good condition.

Wake County Public Health has been in close contact with the J&J drug safety team, NCDHHS and the CDC. Federal officials have worked with several states and local health departments that reported similar reactions. Different vaccine lots from Johnson & Johnson were involved in each incident, and assessments show there is no evidence to suggest an issue with the vaccine doses or the manufacturer.

“We take any reaction to vaccine very seriously, which is why we did our due diligence to examine yesterday’s incident and confer with our CDC, state and local partners,” said Dr. Kim McDonald, Wake County Medical Director. “The total adverse reaction rate at PNC Arena was well below the expected rate for reactions, according to the J&J vaccine federal guidance. In fact, it was less than 1% of the total shots given that day.”

Nationwide, more than 4.5 million J&J vaccines have been given. Locally, 15,988 of those vaccines have been administered by providers throughout Wake County. Wake County Public Health has administered 3,228 J&J vaccines at 22 events and transferred 10,520 doses to community partners. Until yesterday, no adverse reactions had been reported to the county.

“We will never be able to pinpoint exactly what triggered the reactions yesterday, but we do plan to modify our operations to ensure that conditions at our vaccination sites don’t exacerbate reactions in the future,” said Ryan Jury, Wake County Vaccine Branch Director. “We’ll consider factors like weather and logistical settings after seeing Thursday that temperatures were in the 80s on the first day we administered the J&J vaccine at an outdoor drive-thru site.”

In addition, Wake County will bolster efforts to encourage reporting of reactions and encourage recipients to use the V-Safe reporting app. Our Public Health team will continue to monitor that data closely.

Wake County will also look at lowering the volume of vaccinations to ensure patients can be monitored even more closely and enable medical staff, who are always onsite, to quickly assist anyone who may not feel well following their vaccination. The clinical staff will consider additional health questions ahead of vaccinations, as well, to try to better identify those who may have a reaction - a metric that is constantly evolving for all vaccines. Staff may also consider more strongly encouraging people to drink juice or eat something prior to their vaccinations.

Wake County has about 5,000 doses of J&J remaining from its weekly allotment and is currently planning clinics to distribute the doses in the week to come.

Press Release