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CDC, FDA recommend pausing Johnson & Johnson COVID-19 Vaccine

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CDC, FDA recommend pausing Johnson & Johnson COVID-19 Vaccine

The CDC Roybal Campus. Source: CDC.gov
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This story has been updated. 

Atlanta, GA — Following a handful of severe adverse reactions, the CDC and FDA on April 13 announced they are recommending pausing administration of the Johnson & Johnson COVID-19 vaccine.

The CDC has received reports of six people developing a rare type of blood clot after receiving the vaccination.

“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,” the joint press release says. “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.”

The CDC says that more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., and Georgia has received about 256,100 doses, according to the Georgia Department of Public Health. Unlike other vaccines on the market, the Johnson & Johnson vaccine only requires one shot.

“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,” the joint press release says. “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.”

The press release reiterates that these side effects are rare.

“Right now, these adverse events appear to be extremely rare. 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 press release says. “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. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.”

Recently the state Department of Public Health paused administration of the Johnson & Johnson vaccine at the Cumming Fairgrounds “out of an abundance of caution” after eight people experienced adverse reactions. One person was evaluated at a hospital and released. The others were monitored on site and then sent home.

“The reactions were consistent with common reactions in adults being vaccinated with any vaccine, but due to the number of individuals affected, the site stopped the J&J vaccinations to evaluate,” the Department of Public Health says. “There were 425 J&J vaccines administered at the site [last] Wednesday, and tens of thousands of J&J doses have been given statewide with no adverse reactions.”

The state Department of Public Health said at the time that it believed the vaccine was safe.

“There is no reason to believe there is anything wrong with the vaccine itself, and other individuals who have received the J&J vaccine should not be concerned,” DPH Kathleen E. Toomey said in a press release. “We are looking into what happened and what may have caused the reactions, including the conditions at the fairgrounds such as heat and the ability to keep the site cool.”

The press release from DPH noted that the CDC was evaluating these reactions as well as cases in Iowa, Colorado and North Carolina.

Following the CDC and FDA’s recommendation, Georgia paused administration of the Johnson & Johnson vaccine. Here’s the full announcement from the Department of Public Health:

Atlanta – 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.

For updates on COVID-19, follow @GaDPH and @GovKemp on Twitter and @GaDPH and @GovKemp on Facebook.

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