The U.S. Food and Drug Administration limited the authorized use of the Janssen COVID-19 vaccine, otherwise known as the J&J vaccine to a small pool of patients.
The initially single dose vaccine has been limited to use in people 18 and older “for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine,” according to the FDA.
The FDA made this decision after assessing the risk of thrombocytopenia syndrome, or TTS, which can cause rare and potentially life-threatening blood clots and low blood platelet levels, with onset of symptoms occurring one to two weeks after receiving the vaccine.
However, the FDA noted that the benefits of the vaccine outweigh the known and potential risks for adults who cannot receive another COVID-19 vaccine.
“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,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The vaccine was initially authorized for emergency use on Feb. 27, 2021, though use of the vaccine was paused less than two months later after six cases of TTS were reported. The FDA and CDC lifted the pause 10 days after that. Since then, 15 total TTS cases have been reported out of about 8 million doses administered.
In December 2021, after reviewing updated vaccine effectiveness and safety data, the CDC’s Advisory Committee on Immunization Practices made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 Vaccine in all adults 18 years of age and older in the United States.
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