A box of Johnson & Johnson's Janssen COVID-19 vaccine doses are pictured at Grubb's Pharmacy on Capitol Hill in this file photo. On Tuesday, the CDC and FDA issued an official recommendation to pause use of the Johnson & Johnson vaccine out of what agencies called "an abundance of caution," citing a "rare and severe type of blood clot" in some individuals after receiving the single-dose shot. (Photo: Tom Williams/CQ-Roll Call, Inc via Getty Images)
'Out of Abundance of Caution,' FDA and CDC Recommend Pause of Johnson & Johnson Covid-19 Vaccine
Out of 6.8 million doses administered thus far, the agencies said they are "reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine."
This is a breaking news story... Check back for possible updates...
The U.S. Centers for Disease Control and the Food and Drug Administration on Tuesday issued an official recommendation to pause the use of Johnson & Johnson's Covid-19 vaccine out what the agencies called an "abundance of caution," citing a "rare and severe type of blood clot" that some individuals have experienced as a side effect following the single-shot dose.
As of April 12, according to a public statement by the two agencies released via Twitter, more than 6.8 million doses of the J&J vaccine have been administered in the United States. Of those, the agency said it is now "reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare."
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered," the agencies noted.
As part of the review, the CDC will convene a Wednesday meeting of the Advisory Committee on Immunization Practices (ACIP) "to further review these cases and assess their potential significance." FDA, the statement added, will also review the CDC analysis as part of its separate investigation into these cases.
"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," tweeted the FDA.
"Vaccine safety is a top priority for the federal government," the agencies added, "and we take all reports of health problems following COVID-19 vaccination very seriously."
The CDC and FDA will be hosting a live audio press conference at 10:00 are ET to detail the matter and update the public on the decision.
Listen to the press conference:
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This is a breaking news story... Check back for possible updates...
The U.S. Centers for Disease Control and the Food and Drug Administration on Tuesday issued an official recommendation to pause the use of Johnson & Johnson's Covid-19 vaccine out what the agencies called an "abundance of caution," citing a "rare and severe type of blood clot" that some individuals have experienced as a side effect following the single-shot dose.
As of April 12, according to a public statement by the two agencies released via Twitter, more than 6.8 million doses of the J&J vaccine have been administered in the United States. Of those, the agency said it is now "reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare."
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered," the agencies noted.
As part of the review, the CDC will convene a Wednesday meeting of the Advisory Committee on Immunization Practices (ACIP) "to further review these cases and assess their potential significance." FDA, the statement added, will also review the CDC analysis as part of its separate investigation into these cases.
"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," tweeted the FDA.
"Vaccine safety is a top priority for the federal government," the agencies added, "and we take all reports of health problems following COVID-19 vaccination very seriously."
The CDC and FDA will be hosting a live audio press conference at 10:00 are ET to detail the matter and update the public on the decision.
Listen to the press conference:
This is a breaking news story... Check back for possible updates...
The U.S. Centers for Disease Control and the Food and Drug Administration on Tuesday issued an official recommendation to pause the use of Johnson & Johnson's Covid-19 vaccine out what the agencies called an "abundance of caution," citing a "rare and severe type of blood clot" that some individuals have experienced as a side effect following the single-shot dose.
As of April 12, according to a public statement by the two agencies released via Twitter, more than 6.8 million doses of the J&J vaccine have been administered in the United States. Of those, the agency said it is now "reviewing data involving 6 reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare."
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered," the agencies noted.
As part of the review, the CDC will convene a Wednesday meeting of the Advisory Committee on Immunization Practices (ACIP) "to further review these cases and assess their potential significance." FDA, the statement added, will also review the CDC analysis as part of its separate investigation into these cases.
"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," tweeted the FDA.
"Vaccine safety is a top priority for the federal government," the agencies added, "and we take all reports of health problems following COVID-19 vaccination very seriously."
The CDC and FDA will be hosting a live audio press conference at 10:00 are ET to detail the matter and update the public on the decision.
Listen to the press conference: