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FDA Limits Use of Janssen COVID-19 Vaccine

May 6, 2022


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.

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