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EU Says Benefits of J&J Vaccine Outweigh Risks of Rare Blood Clots

The European Medicines Agency says a warning about very unusual blood clots should be added to labels for JNJ's COVID-19 vaccine.
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The European Union’s drug regulator said Tuesday that while there is a possible link between cases of rare blood clots and Johnson & Johnson’s  (JNJ) - Get Johnson & Johnson Report COVID-19 vaccine, the benefits of getting jabs into arms "outweigh the risks of side effects." 

J&J, the New Brunswick, N.J.-based company, was rising 2.3% to $166.43 in trading Tuesday.

The European Medicines Agency said that a warning about very unusual blood clots should be added to labels for Johnson & Johnson’s COVID-19 vaccine.

The agency's safety committee concluded that the clots should be listed as very rare side effects of the vaccine, which was developed by J&J's Janssen Pharmaceutical subsidiary.

"COVID-19 is associated with a risk of hospitalization and death," the agency said in a statement. "The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects." 

One plausible explanation for the combination of blood clots and low blood platelets is an immune response, the EMA said, leading to a condition similar to one seen sometimes in patients treated with the anticoagulant heparin.

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As of April 13, more than 7 million people had received J&J's vaccine in the United States, the agency said.

On Monday, Johnson & Johnson said that it remained committed to delivering 100 million doses of its single-shot vaccine after the U.S. Food & Drug Administration asked Emergent BioSolutions  (EBS) - Get Emergent Biosolutions Inc. Report to stop manufacturing ingredients at its Baltimore factory.

Last week, the Centers for Disease Control and Prevention and the Food and Drug Administration  suspended the use of Johnson & Johnson’s COVID-19 vaccine out of an abundance of caution due to a rare blood-clotting side effect.

The White House said at the time that the decision to pause the use of Johnson & Johnson’s vaccine would not affect the national rollout of vaccines.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the suspension the Johnson & Johnson vaccine could end this week, possibly with restrictions or broader warnings, the Associated Press reported.

Separately, Johnson & Johnson posted stronger-than-expected first-quarter earnings and boosted its full-year earnings forecast.