UNC Health and the UNC vaccination clinic on campus are both pausing their use of the Johnson & Johnson COVID-19 vaccine amid guidance from the federal and state governments.

Both the statewide health care system and the Chapel Hill university issued statements Tuesday morning citing recommendations from the Centers for Disease Control and the Food and Drug Administration to pause administration of the one-shot vaccine. Reports from the federal departments said they are investigating unusual clots in six women that occurred around one week after vaccination with the Johnson & Johnson dose.

The FDA said Tuesday it is launching an investigation into the cause of the clots and low platelet counts in recipients, while the CDC’s Advisory Committee on Immunization Practices is set to meet Wednesday to discuss the cases.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,”said Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a joint statement.

North Carolina’s Department of Health and Human Services also issued a statement, saying the state would following the CDC and FDA’s guidance by temporarily halting distribution of Johnson & Johnson doses.

“Our primary concern is the health and safety of all North Carolinians,” said NCDHHS. “The safety system in place is working as it should.”

Locally, UNC Health said it will not use the one-shot vaccine dose at sites like the Friday Center in Chapel Hill and the Hillsborough clinic, which distributed some Johnson & Johnson doses, until more recommendations are made.

“UNC Health is closely monitoring the situation regarding the J&J COVID vaccine,” read the health care system’s statement. “As a precaution, we will follow the FDA’s recommendation and pause vaccinations using the J&J vaccine until federal authorities are able to review data and provide further guidance.”

Since the Carolina Student Vaccination Clinic on UNC’s campus only administers Johnson & Johnson doses at the current time, the university’s release said the clinic would pause its operations indefinitely “out of an abundance of caution.”

Ken Pittman, the executive director of UNC’s Campus Health, said the health and safety of the UNC community is the group’s top priority and vaccinations will resume at the guidance of public health experts.

“Complications from the Johnson and Johnson vaccine are extremely rare,” Pittman wrote, as most of the 6.8 million doses of the J&J vaccine have resulted in no or mild side effects. “Any student who has already received the vaccine and develops a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact Campus Health or another healthcare provider.”

The pause of Johnson & Johnson vaccines comes shortly after UNC Health briefly stopped using the one-shot doses last week, as the health care system got reports of five people feeling lightheaded or faint after receiving the shot. A spokesperson UNC Health said the system would enact procedures to better help people who shared their fears of needles before receiving the vaccine. At the time, the Centers for Disease Control determined “no evidence of a safety concern” for the J&J vaccines after examining similar instances of adverse reactions across North Carolina and the country.

The development of blood clots is another rare, but potential, side effect of the AstraZeneca COVID-19 vaccine, which the FDA has not yet cleared in the United States. The European Union’s drug regulator said last week there is a “possible link” between the AstraZeneca vaccine and a rare clotting disorder, but reiterated the vaccine is safe and effective.

UNC Health said in its statement people slated to receive the Johnson & Johnson vaccine at vaccination clinics today will instead be offered either the Pfizer or Moderna COVID-19 vaccines or be rescheduled as necessary.

 

Photo via Johnson & Johnson and the Associated Press.


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