Coronavirus: FDA limits Johnson & Johnson vaccine to adults over blood clot risks

The use of Johnson & Johnson vaccines for COVID-19 has been limited to adults who cannot receive other coronavirus shots, U.S. regulators said Thursday.

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The U.S. Food and Drug Administration said in a news release that it limited the use of the COVID-19 vaccine by Johnson & Johnson to people 18 years of age and older when other authorized or approved vaccines were not accessible or clinically appropriate. The agency cited a rare but serious risk of blood clots for strictly limiting who can receive the Janssen COVID-19 vaccine, The Associated Press reported.

“After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 vaccine, warrants limiting the authorized use of the vaccine,” the FDA said in its release.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.”

In December, the Centers for Disease Control and Prevention recommended prioritizing the Moderna and Pfizer shots over the Johnson & Johnson vaccine because of its safety issues, the AP reported. Previously U.S. officials treated all three vaccines similarly because they had each been shown to offer strong protection against COVID-19, according to the news organization.

Follow-up studies have shown lower effectiveness for the Johnson & Johnson vaccine, the FDA stated in its release. Although blood clots from the Johnson & Johnson shots are rare, officials said there are still instances, according to the AP.

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