The U.S. health regulator said on Thursday it was limiting the use of Johnson & Johnson’s COVID-19 vaccine for adults due to the risk of a rare blood clotting syndrome, the latest setback to the shot that has been eclipsed by rivals.
The Johnson & Johnson shot, which received U.S. clearance in February 2021 for adults, 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 Food and Drug Administration said.
Johnson & Johnson is one of the three vaccines in use in the United States. The other two are from Moderna and Pfizer.
The vaccine maker said it 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.
Use of the Johnson & Johnson shot has been weak in high-income countries, hurt by reports of rare, potentially deadly blood clots, production issues, including an accidental mix-up of ingredients by a contract manufacturer, and concerns about efficacy.
Cases of TTS, which involves blood clots accompanied by a low level of platelets, have previously been reported in recipients of the Johnson & Johnson vaccine.
The U.S. Centers for Disease Control and Prevention in December had recommended that Americans choose to receive mRNA shots from Pfizer and Moderna over J&J’s vaccine due to the rare cases of blood clotting.