Alabama To Pause Use Of Johnson & Johnson COVID-19 Vaccine

BIRMINGHAM, AL — Alabama is following federal recommendations and will pause the use of the JOhnson & Johnson COVID-19 vaccine statewide.

The Food and Drug Administration and the Centers for Disease Control and Prevention recommended the pause Tuesday because of blood-clot concerns after six cases were reported.

The FDA reported that, as of Monday, more than 6.8 million doses of the company's vaccine have been administered in the U.S. 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," the FDA said. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."

After neighboring Georgia shut down the use of the Johnson & Johnson vaccine Thursday, Alabama health director Dr. Scott Harris said the Alabama Department of Public Health was looking into the matter in Alabama.

"We have not had any issues reported to us here in Alabama," Harris said.

Harris said Tuesday more than 80,000 unused doses of the Johnson & Johnson vaccine are in the state, and they will be good until June as long as they are properly refrigerated.

"At this time, we feel this is very rare and unlikely to affect most people at all, if it is a true association but right now, we are operating out of an abundance of caution," he said.

"COVID-19 vaccine safety is a top priority for Alabama," Gov. Kay Ivey said Tuesday. "It is important to know that the adverse effects potentially stemming from the Johnson & Johnson shot have been extremely rare in the country. But out of an abundance of caution, Alabama is temporarily pausing these shots until we know more. I commend Dr. Harris for taking this swift step in our state so that we can continue moving forward, getting shots in the arms and putting COVID-19 behind us once and for all."

The CDC reports that 8,500 doses of the Johnson & Johnson vaccine were slated for delivery to Alabama this week.

Winn-Dixie supermarket pharmacies in Alabama have offered the Johnson & Johnson vaccine in Alabama, but the grocery store chain has not issued a statement regarding the status of vaccine appointments at Alabama.

CVS issued a statement saying its pharmacies would implement the pause in distribution of the Johnson & Johnson vaccine immediately.

The CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. The FDA will review that analysis as it also investigates these cases.

"Until that process is complete, we are recommending this pause," the FDA 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."

The CDC and FDA also issued a joint statement from the Johnson & Johnson COVID-19 vaccine from Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, and Anne Schuchat, principal deputy director of the CDC.

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

The pause is important, the statement said, "to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."

"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."