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 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.

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 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.