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alert date:

May 5, 2022

FDA Limits Authorized Use of Johnson & Johnson/Janssen COVID-19 Vaccine

The FDA has limited the authorized use of the Johnson & Johnson/Janssen COVID-19 Vaccine to individuals for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals who elect to receive the Johnson & Johnson/Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine. The FDA has determined that the Johnson & Johnson/Janssen COVID-19 vaccine comes with 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 approximately one to two weeks following administration.

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