FDA limits J&J COVID-19 vaccine use to certain adults

The Food and Drug Administration yesterday revised its emergency use authorization for the Johnson & Johnson COVID-19 vaccine to limit its use to individuals 18 and older for whom the other authorized or approved vaccines are not accessible or clinically appropriate, or who choose to receive it because they would otherwise not receive a vaccine.

“After conducting an updated analysis, evaluation and investigation of reported cases, 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 approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine,” the agency said.

For more information, see the fact sheet for health care providers administering the vaccine.