FDA Restricts Johnson & Johnson Vaccine Over Risk of ‘Life-Threatening’ Blood Clots

On Thursday, the U.S. Food and Drug Administration (FDA) announced that it will restrict the use of the Johnson & Johnson COVID-19 vaccine to adults who cannot receive mRNA vaccines, citing the risk of potentially “life-threatening” side effects.

In a statement, the FDA cited an elevated risk of a life-threatening condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine in making the change.

“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. Dr. Marks added that the J&J vaccine “still has a role to play” in combatting the pandemic.

The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks for certain people. The agency encouraged adults who can’t get an mRNA vaccine for medical reasons to take the Johnson & Johnson vaccine, however.

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, according to a report from the Associated Press. 

As of Thursday, more than 18.7 million doses of the Johnson & Johnson vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention. Of those who are considered fully vaccinated, 7.7% got this vaccine.

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