FDA Limits Use Of Johnson & Johnson COVID-19 Vaccine Due To Blood Clot Risk

The U.S. Food and Drug Administration has limited use of Johnson & Johnson's COVID-19 vaccine over concerns of rare side effects including blood clots.

The FDA said it has restricted authorized use of the vaccine to individuals 18 years of age and older who would not otherwise become vaccinated against COVID-19.

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 about one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the 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 Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

The agency said it will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.

The single-dose Janssen COVID-19 Vaccine was authorized in February 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention or CDC temporarily paused administering the shot to investigate six reported cases of TTS.

On April 23, 2021, the FDA and CDC lifted the recommended pause regarding the use of the Janssen COVID-19 Vaccine. The agencies confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS), including the original six reported cases, out of about 8 million doses administered.

In December 2021, the CDC recommended that people take the mRNA COVID-19 vaccines made by Pfizer and Moderna instead of Johnson & Johnson's single-shot COVID-19 vaccine due to a rare blood clotting disorder.

In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

The FDA said it also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate. The agency also considered the availability of alternative authorized and approved COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS.

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