NJ Pauses Johnson & Johnson COVID Vaccine

NEW JERSEY – New Jersey paused the use of the Johnson & Johnson COVID-19 vaccine on Tuesday because of blood-clot concerns. The state took action following the Food and Drug Administration and the Centers for Disease Control and Prevention's recommendation.

All New Jersey vaccination sites have been told to cancel or put on hold appointments for the J&J vaccine until further notice, according to Health Commissioner Judith Persichilli.

For anyone scheduled to receive the J&J vaccine, the department will work with all vaccination sites to make arrangements for the administration of an alternative two-dose vaccine, she said.

"We will work with all sites, as needed, to reschedule vaccination appointments," she said.

The FDA and CDC, which addressed the issue during a media call, said the pause will likely be a "matter of days." Watch here:

About 200,000 of the 5 million people who have gotten at least one shot in New Jersey received Johnson & Johnson's vaccine, but Gov. Phil Murphy said the state's goal of fully vaccinating 4.7 million adults by the end of June is still "entirely achievable."

Murphy also said no one in New Jersey has reported suffering from a blood clot after getting the Johnson & Johnson vaccine.

"No one who has received this vaccine should panic or worry," Murphy said.

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."

At least three pharmacies announced that they will pause the distribution of the vaccine. Read more: NJ Pharmacies To Stop Using Johnson & Johnson Vaccine

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. 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 on 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."

Johnson & Johnson released a statement on the matter:

"The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine.....

"In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe."

"We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public. The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot.

"The health authorities advise that people who have received our COVID-19 vaccine and develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

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.

Gov. Phil Murphy has 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 in New Jersey this past week.

Murphy said the vaccines received in New Jersey were not contaminated, saying all of the J&J supplies so far have come from the Netherlands.

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