FDA, CDC recommend pausing Johnson & Johnson COVID vaccine due to rare blood clotting issue

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This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the COVID-19 vaccine in the United States. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (Johnson & Johnson via AP)

AUSTIN (KXAN) — The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are calling for the U.S. to pause the use of the one-shot Johnson & Johnson COVID-19 vaccine out of “an abundance of caution” due to rare, severe blood clots.

Officials released the statement Tuesday morning saying there have been “extremely rare” blood clotting issues found in people who took the vaccine. The FDA says more than 6.8 million doses of the vaccine have been administered, and six cases of a severe type of blood clot have developed.

“All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination,” the FDA said in a statement.

“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” the FDA added. “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 FDA and CDC are reviewing data and the cases, and will convene a committee a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to start an investigation. Until that process is done, the agencies said the use of Johnson & Johnson vaccines should be paused “due to the unique treatment required with this type of blood clot.”

The Texas Department of State Health Services released a statement shortly after the announcement adhering to the federal government’s recommendation.

The Texas Department of State Health Services is asking vaccine providers in Texas to pause all administration of the Johnson & Johnson/Janssen COVID-19 vaccine following today’s recommendation from the Centers for Disease Control and Prevention and the Food and Drug Administration.

The pause is recommended following reports of blood clots in six individuals 6 to 13 days after receiving the Johnson & Johnson vaccine. Right now, these adverse events appear to be extremely rare and are being further evaluated to ensure vaccine safety. People who have received the Johnson & Johnson vaccine who develop a severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider.

None of the cases of blood clots reported at this time have occurred in Texas, where more than 500,000 doses of the Johnson & Johnson vaccine have been administered.

DSHS has not been notified of any change in vaccine distribution. Providers that have or receive the Johnson & Johnson vaccine should continue to store it in the proper conditions. Providers should report all adverse events following any vaccination to the Vaccine Adverse Events Reporting System at vaers.hhs.gov.

Texas Department of State Health Services

The agencies will hold a news conference at 9 a.m. on the FDA’s YouTube channel to discuss the pause. We will stream it live in this story and on Facebook.

The FDA says people who have gotten the Johnson & Johnson vaccine who “develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.”

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