Feds: Pause Johnson & Johnson COVID Vaccine In NY, Elsewhere

NEW YORK — 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. The pause would impact many New York vaccination sites.

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

New York Department of Health Commissioner Dr. Howard Zucker said Tuesday in a prepared statement that the state will follow the CDC and FDA recommendation and pause the use of the Johnson & Johnson vaccine statewide immediately.

He said all appointments for the J&J vaccines Tuesday at New York State mass vaccination sites will be honored with the Pfizer vaccine.

"As the CDC and FDA have said, any adverse events related to the Johnson & Johnson vaccine 'appear to be extremely rare' and, '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,' " Zucker said.

"I am in constant contact with the federal government and we will update New Yorkers as more information becomes available," he said.

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 New Jersey-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 about 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 six 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.

Moderna released a statement saying that its vaccine has not had the same consequences.

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.

New Jersey Gov. Phil Murphy had sought to reassure people that the Johnson & Johnson vaccine is safe despite a recent incident that led to the "contamination" of 15 million vaccines.

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.

Written by Tom Davis/Patch with additional reporting by Michael Woyton/Patch.