FDA Limits Use of J&J’s COVID-19 Vaccine

Citing the risk of rare blood clots, the FDA announced late yesterday that it is limiting the Emergency Use Authorization (EUA) for the Johnson & Johnson/Janssen COVID-19 vaccine to certain individuals.

The EUA now covers individuals age 18 years and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals age 18 years and older who choose to receive the Janssen COVID-19 vaccine “because they would otherwise not receive a COVID-19 vaccine,” the agency said.

“Our action reflects our updated analysis of the risk of [thrombosis with thrombocytopenia syndrome (TTS)] following administration of this vaccine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.”

The fact sheet for healthcare providers will now include a prominent warning statement about the risk of the syndrome.

The J&J vaccine was authorized for emergency use on Feb. 27, 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention recommended a pause in vaccinations to investigate six reported cases of the syndrome. The pause was lifted the following week.

In a comment to FDAnews, J&J said “language about the risk of TTS has been added to the first page of the Fact Sheet to increase its prominence. This update further highlights the potential risk of TTS and does not reflect a change in the rate of cases observed.”