FDA Advisory Limits Use Of Johnson & Johnson COVID-19 Vaccine

OLYMPIA, WA — New guidance from the U.S. Food and Drug Administration now strongly recommends that anyone still seeking COVID-19 vaccines choose alternative options over the Johnson & Johnson vaccine.

The FDA's new ruling limits the use of the J&J vaccine to adults 18 years old or older, who either cannot access the other COVID-19 vaccines or who want the J&J shot and would not otherwise get vaccinated.

Shortly after the FDA released the updated health advisory, the Washington State Department of Health cancelled its standing order for the Johnson & Johnson shots. Back in December, the state DOH officially recommended the Pfizer and Moderna vaccines over the J&J, in part because the one-dose J&J vaccine has been linked to thrombosis and thrombocytopenia syndrome. The syndrome, sometimes called TTS, is a rare but serious condition causing dangerous blood clots and a low platelet count. Millions of doses of the Johnson and Johnson vaccine have been administered, but only 60 patients have suffered TTS, though nine of those have died, including a King County woman.

The FDA says TTS complications are also the reason it is now officially limiting the application of the J&J shot.

“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. 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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Patients who still choose to take the Johnson & Johnson vaccine are asked to know the symptoms of an adverse reaction, which include severe headaches, abdominal pain, leg swelling, and shortness of breath. Anyone who suffers those symptoms after taking a J&J dose should contact their health care provider or an urgent care center.

As of the latest update from the DOH, 13.7 million COVID-19 vaccine doses have been administered in Washington, and the state still averages nearly 10,000 doses administered each day.

>> Read more on vaccine safety and efficacy from the Washington State Department of Health.