April 13, 2021- The Centers for Disease Control and Prevention and the Federal Drug Administration released a joint statement about the Johnson & Johnson COVID-19 Vaccine. 

"As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. 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 J&J vaccine. In these cases, 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. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, 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."

Read the complete statement here. 

Furthermore, the Georgia Department of Public Health (DPH) released a statement where it announced that J&J vaccinations in the state are paused. 

"Following the guidance and recommendations of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), the Georgia Department of Public Health (DPH) is pausing J&J (Janssen) vaccinations in Georgia until further notice.

The FDA and CDC are reviewing data involving six reported cases of a rare and severe type of blood clot occurring in women aged 18-48 about a week after vaccination. None of the six cases are in individuals vaccinated in Georgia and are unrelated to the reactions reported last week at the Cumming Fairgrounds site. DPH 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, and we ask for patience while scheduling arrangements and adjustments are made.

Right now, these adverse events appear to be extremely rare, but out of an abundance of caution DPH will temporarily stop the administration of the J&J vaccine while scientists review the data around these cases. More than 124,000 doses of J&J vaccine have been safely administered in Georgia.

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. 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.

Vaccination remains one of our best tools for stopping the spread of COVID-19, along with basic prevention measures – wearing a mask, distancing from others, avoiding large gatherings and frequent hand washing.

DPH will continue to monitor the situation with J&J vaccines and provide additional information as it becomes available."

Attached is a copy of the official press release. 

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