MN Asks Vaccine Providers To Pause J&J After Federal Guidance

MINNESOTA— 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.

According to the CDC, Minnesota was set to receive nearly 9,600 Johnson & Johnson shots this week.

Officials have not yet released information about what will happen to community vaccination clinics in Minnesota, many of which used the Johnson & Johnson shots, but the Minnesota Department of Health said that those who were scheduled to receive the shot should watch for notifications about canceling, postponing, or rescheduling their appointment.

The Minnesota Department of Health said they advised Minnesota health care providers, recommending that they pause the administration of the Johnson & Johnson vaccine.

The Department of Health said they were not aware of any cases of blood clots in the 184,000 Minnesotans, or 6.6 percent of COVID-19 vaccines in the state, who had received the Johnson & Johnson vaccine.

"We are recommending a pause in the use of this vaccine out of an abundance of caution," the FDA announced on Twitter.

The FDA reported that, as of Monday, more than 6.8 million doses of New Brunswick-based 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."

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.

CVS also issued a statement, saying they would be "immediately implementing a pause in the use of the Johnson and Johnson's COVID-19 vaccine per the recommendation from federal health agencies."

Jeff Zients, White House COVID-19 coordinator, said the pause will not have drastic effects on the White House's plan to get vaccines for all Americans.

"This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date," Zients said. "Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines. This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office—and continue on to reach every adult who wants to be vaccinated. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine."

The statement from the FDA 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 Tuesday's media call will be available on the FDA's YouTube channel.

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

See also:

Johnson & Johnson Vaccine Pause: 6 Things To Know