"The Tennessee Department of Health is acting upon recent guidance from the Food and Drug Administration and the Centers for Disease Control and Prevention to pause administration of the Johnson & Johnson COVID-19 vaccine," officials said in the announcement. "Our vaccine supply continues to surpass demand and we do not anticipate this shift will impact our efforts to vaccinate as many Tennesseans as possible. We continue to monitor the situation closely."
The six cases occurred six to 13 days after vaccination in women between the ages of 18-48, according to a joint statement from the FDA and CDC.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a media conference that one case was fatal, and one patient is in critical condition.
The single-shot Johnson & Johnson vaccine is the least administered nationwide among the three versions of the vaccine available to Americans. According to CDC data, about 6.9 million doses of the Johnson & Johnson vaccine have been administered, accounting for about 3.6% of all doses. There have been no similar complications reported as a result of either the Moderna or Pfizer BioNTech vaccines.
In Tennessee, approximately 317,600 doses of the Johnson & Johnson vaccine have been delivered through public and private providers, according to the Tennessee Department of Health. Officials said they have begun working with providers to help provide them with the Moderna or Pfizer BioNTech vaccine in place of the Johnson & Johnson version.
Dr. Anne Schuchat, principal deputy director of the CDC, said anyone who received the vaccine within about the last two weeks should be aware of symptoms including severe headaches, abdominal pain, leg pain or shortness of breath and contact their health care provider to seek medical treatment if the symptoms occur.
"These symptoms are different from the mild, flu-like symptoms that many people experience in the couple of days after receiving the vaccine," Schuchat said in the call with reporters.
Although the cases are extremely rare—fewer than one in 1 million recipients of the Johnson & Johnson vaccines experienced the blood clot—the CDC and FDA are reviewing the cases during this recommended pause. Dr. Janet Woodcock, acting commissioner of the FDA, told reporters she expects the pause to be "a matter of days."
Marks emphasized the FDA and CDC message to providers is a recommendation and not a mandate, leaving both medical providers and patients to make individual decisions.
"If an individual health care provider has a conversation with an individual patient and they determine that the benefit-risk for that individual patient is appropriate, we’re not going to stop that provider from administering the vaccine," he said.
Wendy Sturges contributed to this report.