Feds: Pause Johnson & Johnson COVID-19 Vaccine In PA, Nationwide

PENNSYLVANIA – 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 due to concerns about blood clots.

The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot after receiving the vaccine. As of Monday, more than 6.8 million doses of the single-dose vaccine have been administered in the United States, according to the FDA.

"We are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Peter Marks of the FDA and Dr. Anne Schuchat of the CDC said in a joint statement.

In Pennsylvania, the Johnson & Johnson shot was used in a special initiative to vaccinate more than 112,500 teachers and school staff in about three weeks. That initiative was completed earlier this month.

"Right now, these adverse events appear to be extremely rare," Marks and Schuchat said in the joint statement from the FDA and CDC. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."

Pennsylvania was slated to receive 20,000 doses of the Johnson & Johnson vaccine this week, and Philadelphia another 2,800, according to CDC data.

Pennsylvania had just moved to phase 1C Monday when Gov. Tom Wolf announced all residents would be eligible to receive the vaccine on Tuesday. It's unclear how the announcement regarding Johnson & Johnson will impact that timeline. Patch has reached out to officials and will update this story as more information comes in.

Some pharmacies that operate in Pennsylvania have announced they're pausing the use of the company's vaccine for the time being.

The move to pause the use of the vaccine comes weeks after the FDA halted production of the J&J vaccine at a Baltimore facility run by Emergent BioSolutions following a mix-up in ingredients. However, the company said none of the 15 million doses that had been tainted were ever shipped out from the plant.

The CDC's Advisory Committee on Immunization Practices will meet Wednesday to further review the blood clot cases and assess their potential significance. The FDA will review that analysis as it also investigates.

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

Blood Clot Prompts Investigation

The CDC and FDA issued a joint statement about the decision to stop using the J&J vaccine with more detail on the cases that prompted the investigation.

"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."

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.

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

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System. Leaders from the CDC and FDA will provide additional information and answer questions at a media briefing at 10 a.m. that will be broadcast on YouTube.

With reporting by Tom Davis and Elizabeth Janney