Feds Pause Johnson & Johnson COVID-19 Vaccine In GA, Across US

GEORGIA – The Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause, including in Georgia, 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," Dr. Peter Marks of the FDA and Dr. Anne Schuchat of the CDC said in a joint statement.

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.

More than 124,000 doses of J&J vaccine have been administered in Georgia, the Department of Public Health said Tuesday.

None of the six blood clot cases are in individuals vaccinated in Georgia, and are unrelated to the reactions reported last week at the Cumming Fairgrounds site, the Department of Public Health said Tuesday.

"Individuals who have received the J&J vaccine and develop severe headache, abdominal pain leg pain or shortness of breath within three weeks after vaccination should contact their health care providers," the Department of Public Health said in a statement. "DPH urges all health care providers to be aware of the potential for these adverse events and plan for appropriate treatment required with these types of blood clots."

Across the state, 1,744,617 Georgians have been fully vaccinated with all three versions — J&J, Moderna and Pfizer — according to the Georgia Department of Public Health.

Marks said in a joint media call Tuesday morning, with Schuchat and Active FDA Commissioner Dr. Janet Woodcock, that there have been more than 180 million doses of the coronavirus vaccine administered nationwide, and there have not been other reports of blood clot concerns.

There is no set time frame for the pause, Woodcock said in the call, because that will depend on what health officials learn in the new few days, but she does expect the pause to only last a few days.

The Georgia Department of Public Health and District Health Departments are working to provide Pfizer or Moderna vaccines for individuals with previously scheduled appointments for the J&J vaccine. In some cases, this may require rescheduling.

"We are committed to an expeditious review of the available information, and to an aggressive outreach to clinicians so they know how to diagnosis, treat and report," Schuchat said. "One of the things that the deliberation will do is review the data on the case and the context of risk-benefit, and the possible subsets of population that may be in a different category. Our plan is, in the days ahead, to provide an update regularly and that the pause provides us time for deliberation and assuring appropriate diagnosis and treatment."

Marks said there is no definitive cause of the blood clot concerns yet, but it may be an immune response that rarely occurs after some people receive the vaccine.

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.

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"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."

The move to pause 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."

As of Tuesday morning, several pharmacies have announced they are pausing the distribution of the vaccine.

That includes Walgreens, which said, "We're pausing J&J vaccines immediately, and we'll have more details soon."

CVS said it is "immediately implementing a pause in the use of the Johnson and Johnson’s COVID-19 vaccine per the recommendation from federal health agencies."

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 provided additional information at a media briefing that was broadcast on YouTube.

— By Tom Davis and Elizabeth Janney