Feds: Pause Johnson & Johnson COVID Vaccine in OH, Elsewhere

OHIO — 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," the FDA announced on Twitter.

The FDA and CDC are expected to address the issue during a 10 a.m. media call. Watch live here:

The FDA reported that, as of Monday, more than 6.8 million doses of Johnson & Johnson's one-shot 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."

The news comes after reports of a New Jersey man who became very sick with COVID-19 weeks after getting the Johnson & Johnson vaccine. The case, however, appears to have no connection to the federal government's actions on Tuesday.

Just yesterday, Gov. Mike DeWine was at Ohio University encouraging college students to get the one-shot Johnson & Johnson COVID-19 vaccine. He acknowledged that while COVID-19 didn't usually cause college-age students to get very sick, it was still important to get young people to take the shot to achieve herd immunity.

This morning, however, Gov. Mike DeWine's office made an announcement advising all Ohio vaccine providers to temporarily pause the use of the Johnson & Johnson vaccine.

Read more: Edison Man Hospitalized With COVID-19 After J&J Vaccine: Reports

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."

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at CDC and FDA will provide additional information and answer questions later on Monday at a media briefing.

A recording of that media call will be available on the FDA's YouTube channel.

There was also a recent issue with 15 million Johnson & Johnson vaccines being contaminated. Human errors at a manufacturing plant that caused the company to throw out the vaccines also led to a sharp drop in supplies this past week.

This is a developing story. Patch will have more information as it comes in.