The Food and Drug Administration on Thursday limited the use of the Johnson & Johnson/Janssen COVID-19 vaccine to adults who can’t access or refuse to get the Pfizer-BioNTech or the Moderna vaccines, citing concerns over safety.

  • Driving the news: A statement from the FDA said that the agency evaluated available data and determined that there is a risk of rare but life-threatening blood clots, warranting limited use of the vaccine.
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What they’re saying: “We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

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  • “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions,” he said in conclusion.

Details: Anyone with low blood platelet levels runs the risk of thrombosis with thrombocytopenia syndrome (TTS), an affliction that causes blood clots. In the case of the J&J vaccine, the potential risks outweigh the potential benefits, the FDA statement said.

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A total of 15 cases of TTS out of 8 million doses administered were reported to the Vaccine Adverse Event Reporting Systems.

The symptoms of TTS typically began one or two weeks after the vaccine was administered, an updated factsheet on the vaccine stated, adding that “approximately 15% of TTS cases have been fatal.”

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What Johnson & Johnson said: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine,” a J&J spokesman said.

Flashback: Per CBS News, in December, the Centers for Disease Control and Prevention recommended that health care providers prioritize the Moderna and Pfizer vaccines over Johnson & Johnson due to safety concerns.

  • While the blood clots are rare, the J&J vaccine also offered lower protection than other vaccines.