The FDA said it was limiting the use of Johnson & Johnson's JNJ COVID-19 vaccine for adults due to the risk of a rare blood clotting syndrome.
The J&J shot can be administered in cases where authorized or approved COVID-19 vaccines are not accessible, or if an individual is less keen on using the other two shots, the FDA said.
The FDA said the risk of TTS warranted limiting the use of the single-dose shot after it investigated reported cases.
The company has updated the U.S. COVID-19 vaccine fact sheet to warn about the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially life-threatening condition.
Last month, JNJ suspended its forecast for COVID-19 vaccine sales, citing a glut of supply.
TTS cases, which involve blood clots accompanied by a low level of platelets, have previously been reported in recipients of the J&J vaccine.
The FDA in January amended the fact sheet for the J&J vaccine to include the risk of immune thrombocytopenia.
The U.S. Centers for Disease Control and Prevention had recommended that Americans choose to receive mRNA shots from Pfizer Inc PFE / BioNTech SE BNTX and Moderna Inc MRNA over J&J's vaccine due to the rare cases of blood clotting.
Price Action: JNJ shares closed 1.11% lower at $175.00 during after-hours trading on Thursday.
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