Feds recommend pausing J&J vaccine over blood clotting concerns


Federal health agencies on Tuesday recommended an immediate pause in the use of Johnson & Johnson’s coronavirus vaccine after six people developed a rare and severe type of blood clot after receiving the shot.

All those affected were women between the ages of 18 and 48, and their symptoms developed 6-13 days after vaccination, the Food and Drug Administration and the Centers for Disease Control and Prevention said in a joint statement.

Johnson & Johnson later Tuesday said it would delay the rollout of its shot in Europe while safety data is reviewed.

More than 6.8 million doses of the single-shot vaccine had been administered in the United States as of Monday, the agencies said. “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,” White House Covid-19 response coordinator Jeff Zients said in a statement.

CDC’s vaccine advisory committee will meet Wednesday to review the blood clotting incidents. The FDA, which is set to hold a press conference Tuesday morning, will review the CDC analysis and conduct its own investigation.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA’s top vaccine regulator, Peter Marks, and CDC Principal Deputy Director Anne Schuchat said a joint statement.

“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 officials added.

“Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine,” Johnson & Johnson said in a statement. “In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.”

Concerns about blood clots first emerged while the FDA was reviewing the J&J vaccine for emergency authorization. The agency’s vaccine advisory committee recommended the shot be authorized in a 22-0 vote in late March but noted a potential link to rare cases of clotting. FDA said then the available information did not demonstrate a link between the shot and the clotting reports, but that it would continue to monitor how often blood clots occur in the broader population to understand any connection to the vaccine.

The advisory from federal health officials comes just days after the European Medicines Agency said it was investigating four reports of blood clotting in people who received the J&J vaccine. One of the cases occurred in a person participating in a clinical trial, while the other three were reported in the U.S., the European regulator said Friday.

The EMA said that all four cases were so-called thromboembolic events — in which a blood clot forms in a vessel, breaks off and blocks another vessel — and that one person died. The agency added that it was not clear whether the clots were a side effect of the vaccine.

European regulators have also been probing reports of blood clots related to a Covid-19 vaccine from AstraZeneca, which like Johnson & Johnson uses a weakened adenovirus as the basis for its shot. The EMA said last week that there is a “possible link” between the AstraZeneca shot and cases of blood clotting and low platelets, but backed the vaccine’s continued use.

The European agency is also investigating links between the AstraZeneca shot and another rare condition called capillary leak syndrome, in which fluid leaks from blood vessels causing tissues to swell and blood pressure to drop.

While U.S. health agencies’ recommendation to pause use of the J&J vaccine most immediately affects federal vaccination sites, the agencies said that they are recommending states and health care providers follow suit in part to allow medical personnel to learn more about the particular type of clotting that has been reported.

“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” Marks and Schuchat said in their statement. “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.”

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Federal health agencies on Tuesday recommended an immediate pause in the use of Johnson & Johnson’s coronavirus vaccine after six people developed a rare and severe type of blood clot after receiving the shot.

All those affected were women between the ages of 18 and 48, and their symptoms developed 6-13 days after vaccination, the Food and Drug Administration and the Centers for Disease Control and Prevention said in a joint statement.

Johnson & Johnson later Tuesday said it would delay the rollout of its shot in Europe while safety data is reviewed.

More than 6.8 million doses of the single-shot vaccine had been administered in the United States as of Monday, the agencies said. “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,” White House Covid-19 response coordinator Jeff Zients said in a statement.

CDC’s vaccine advisory committee will meet Wednesday to review the blood clotting incidents. The FDA, which is set to hold a press conference Tuesday morning, will review the CDC analysis and conduct its own investigation.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA’s top vaccine regulator, Peter Marks, and CDC Principal Deputy Director Anne Schuchat said a joint statement.

“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 officials added.

“Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine,” Johnson & Johnson said in a statement. “In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.”

Concerns about blood clots first emerged while the FDA was reviewing the J&J vaccine for emergency authorization. The agency’s vaccine advisory committee recommended the shot be authorized in a 22-0 vote in late March but noted a potential link to rare cases of clotting. FDA said then the available information did not demonstrate a link between the shot and the clotting reports, but that it would continue to monitor how often blood clots occur in the broader population to understand any connection to the vaccine.

The advisory from federal health officials comes just days after the European Medicines Agency said it was investigating four reports of blood clotting in people who received the J&J vaccine. One of the cases occurred in a person participating in a clinical trial, while the other three were reported in the U.S., the European regulator said Friday.

The EMA said that all four cases were so-called thromboembolic events — in which a blood clot forms in a vessel, breaks off and blocks another vessel — and that one person died. The agency added that it was not clear whether the clots were a side effect of the vaccine.

European regulators have also been probing reports of blood clots related to a Covid-19 vaccine from AstraZeneca, which like Johnson & Johnson uses a weakened adenovirus as the basis for its shot. The EMA said last week that there is a “possible link” between the AstraZeneca shot and cases of blood clotting and low platelets, but backed the vaccine’s continued use.

The European agency is also investigating links between the AstraZeneca shot and another rare condition called capillary leak syndrome, in which fluid leaks from blood vessels causing tissues to swell and blood pressure to drop.

While U.S. health agencies’ recommendation to pause use of the J&J vaccine most immediately affects federal vaccination sites, the agencies said that they are recommending states and health care providers follow suit in part to allow medical personnel to learn more about the particular type of clotting that has been reported.

“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” Marks and Schuchat said in their statement. “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.”

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