FDA Limits Use of Johnson & Johnson COVID Vaccine Due to Risk of Thrombosis

The Food and Drug Administration (FDA) has announced that it is limiting use of Johnson & Johnson's COVID-19 vaccine over concerns of rare side effects including blood clots.

The FDA announced on Thursday that it was restricting authorized use of the vaccine, which is produced by the Johnson & Johnson-owned company Janssen Pharmaceuticals, to adults age 18 and over who would not otherwise become vaccinated against COVID. The agency said that the risk of the vaccine causing thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially fatal blood clotting condition, "warrants" limiting its use.

"We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement published by the FDA. "Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals."

"Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions," he added. "The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information."

Johnson & Johnson Janssen Vaccine FDA Restrictions
The FDA announced Thursday that it is limiting the use of Johnson & Johnson's COVID-19 vaccine due to risk of thrombosis. A vial of the Janssen COVID-19 Vaccine is shown in this photo taken at a clinic in Los Angeles, California, on December 15, 2021. FREDERIC J. BROWN/AFP/Getty

An updated FDA fact sheet for the vaccine notes that approximately 15 percent of TTS cases associated with the vaccine have been fatal. However, the risk of developing the condition or dying from it remains low, occurring at a rate of 3.23 cases and 0.48 deaths per 1 million doses administered, according to the FDA.

The FDA said that the vaccine was still approved for use when other COVID vaccines were "not accessible or clinically appropriate" or when individuals choose to use it "because they would otherwise not receive a COVID-19 vaccine."

Out of the nearly 220 million people who had been fully vaccinated against COVID in the U.S. as of Thursday, just under 17 million had been vaccinated with the Janssen vaccine, according to the U.S. Centers for Disease Control and Prevention (CDC).

Last year, the FDA recommended that Americans use two other approved or authorized vaccines made widely available, developed by Pfizer/BioNTech and Moderna. Both were developed using the mRNA platform rather than the viral vector method that was used for the Janssen vaccine.

The agency cited concerns about TTS and evidence that the single-dose vaccine was less effective than the mRNA vaccines, which require two initial doses. Johnson & Johnson said that it remained "confident in the overall positive benefit-risk profile" of its vaccine at the time.

In a statement obtained by Newsweek on Thursday, Johnson & Johnson said that data still supports a "favorable benefit-risk profile" for the vaccine "when compared with no vaccine," noting that the FDA action "does not reflect a change in the rate of [TTS] cases observed."

"Johnson & Johnson continues to collaborate with health authorities and regulators around the world to ensure healthcare professionals and individuals are warned and fully informed about reports of TTS, enabling correct diagnosis, appropriate treatment, and expedited reporting," the statement said.

"The Johnson & Johnson COVID-19 vaccine plays a crucial role in the global fight to end the COVID-19 pandemic," it continued. "The Company continues to focus its efforts on ensuring its vaccine is available during the pandemic where people are most in need."

Newsweek reached out to Janssen Pharmaceuticals for comment.