FDA Limits Janssen’s COVID-19 Vaccine

Due to the risk of blood clots, the FDA is limiting the authorized use of the Janssen COVID-19 vaccine.

Now, the use of the vaccine is limited to people 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, the FDA said in a statement.

After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare syndrome of potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms about one to two weeks after administration of the Janssen COVID-19 vaccine, warrants limiting the authorized use of the vaccine.

“The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine,” the agency said.

Peter Marks, M.D., Ph.D.

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

The Fact Sheet for Healthcare Providers Administering Vaccine now includes a warning statement on the risk of TTS and the Janssen vaccine. In addition, information on the revised authorized and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.

In mid-April 2021, the FDA and the CDC announced a recommended pause in administration of Janssen’s vaccine to investigate six reported cases of TTS. Then, on April 23, 2021, following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA and CDC lifted the recommended pause regarding the use of the Janssen COVID-19 Vaccine.

At the time, the agencies confirmed that a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS), including the original six reported cases, out of about 8 million doses administered.