Feds Pause Johnson & Johnson COVID Vaccine In NC, Across US

NORTH CAROLINA – The Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday because of blood-clot concerns.

"We are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Peter Marks of the FDA and Dr. Anne Schuchat of the CDC said in a joint statement.

The development comes just days after one North Carolina vaccination site temporarily halted administering the shot after 18 people had adverse reactions.

SEE ALSO: Adverse Reactions Temporarily Halt J&J Vaccinations At NC Site

As of Monday, more than 6.8 million doses of the single-dose vaccine have been administered in the United States, according to the FDA.

In North Carolina, J&J shots represent a small portion of the more than 41 percent of adults who are partially vaccinated and 30 percent fully vaccinated, according to the North Carolina Department of Health and Human Services. Of the nearly 5.9 million doses of COVID vaccine that have been administered in the state as of Monday, 218,690 were J&J vaccines.

Information about where to find a vaccine provider in North Carolina may be found here.

SEE ALSO: Publix Now Vaccinating In NC: See Where Appointments Remain

The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

"Right now, these adverse events appear to be extremely rare," Marks and Schuchat said in the joint statement from the FDA and CDC. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."

The move to pause use of the vaccine comes weeks after the FDA halted production of the J&J vaccine at a Baltimore facility run by Emergent BioSolutions following a mix-up in ingredients.
However, the company said none of the 15 million doses that had been tainted were ever shipped out from the plant.

The CDC's Advisory Committee on Immunization Practices will meet Wednesday to further review the blood clot cases and assess their potential significance. The FDA will review that analysis as it also investigates.

"Until that process is complete, we are recommending this pause," officials said. "This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

SEE ALSO: Johnson & Johnson Vaccine Pause: 6 Things To Know

Blood Clot Prompts Investigation
The CDC and FDA issued a joint statement about the decision to stop using the J&J vaccine with more detail on the cases that prompted the investigation.
"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," the statement said. "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to the statement.

Officials said a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System. Leaders from the CDC and FDA will provide additional information and answer questions at a media briefing at 10 a.m. that will be broadcast on YouTube.

This is a developing story and will be updated.

— By Tom Davis and Elizabeth Janney