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FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.
FDA announced on May 5, 2022 that it has limited the emergency use authorization (EUA) of the Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age or older who elect to receive the vaccine because they would otherwise not receive a COVID-19 vaccine.
FDA warrants the EUA limitation to the risk of thrombosis with thrombocytopenia syndrome (TTS) associated with the vaccine. TTS is a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets. Onset of symptoms have been seen approximately one to two weeks following the administration of the Janssen vaccine.
FDA has determined that, for the specified groups the vaccine is to be limited to, the known and potential benefits of the vaccine outweigh the known and potential risks. The revision of the authorized use of the vaccine is reflected in the Fact Sheet for Healthcare Providers Administering Vaccine, which includes a warning statement summarizing the risk for TTS.
“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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. 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. The agency 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.”