The FDA and CDC called for a pause on the single-dose vaccine "out of an abundance of caution" after six women developed a rare blood clot disorder

By Georgia Slater
April 13, 2021 10:00 AM
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The Food and Drug Administration and the Centers for Disease Control and Prevention are calling for an immediate halt on the single-dose Johnson & Johnson coronavirus vaccine after six recipients in the United States developed a rare blood clotting disorder within two weeks of vaccination.

On Tuesday, the FDA and the CDC issued a joint statement recommending a pause on the use of the vaccine "out of an abundance of caution," adding that the "adverse events" appear to be "extremely rare." Of the more than 6.8 million people in the U.S. have received the Johnson & Johnson vaccine so far, and only 6 have reported cases of the blood clotting disorder.

According to The New York Times, the reported cases were all women between the ages of 18 and 48. One woman died and a second woman has been hospitalized in critical condition.

"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," the statement read.

"Until that process is complete, we are recommending this pause. 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," the agencies added.

The FDA and CDC also noted that "treatment of this specific type of blood clot is different from the treatment that might typically be administered."

Pfizer-BioNTech COVID-19 vaccine
A woman receiving a COVID-19 vaccine
| Credit: FRANK AUGSTEIN/POOL/AFP via Getty

A news conference regarding the recommendation is scheduled for 10 a.m ET Tuesday, the FDA announced.

Following the announcement by the FDA and CDC, Johnson & Johnson issued a statement confirming that the company is "aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines," ABC News reported.

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"At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine," the statement read. "We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public."

"The safety and well-being of the people who use our products is our number one priority. We share all adverse event reports about individuals receiving our COVID-19 vaccine, along with our assessment of these reports, with health authorities in compliance with regulatory standards," Johnson & Johnson said.

The White House said that the U.S. has enough doses of Pfizer and Moderna vaccines to continue the vaccine distribution.

"This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date," Jeff Zients, the White House COVID-19 Response Coordinator, said in a statement shared with PEOPLE. "Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans."

"We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine," he added.

As of Tuesday morning, there have been more than 31.2 million reported cases of the coronavirus in the U.S. and at least 562,007 deaths, according to data from the Times.

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