FDA Restricts Use of J&J COVID-19 Vaccine after New Evaluation of TTS Risk

The US Food and Drug Administration (FDA) on Thursday announced it is limiting authorized use of the Janssen COVID-19 vaccine.

Adminstration of the vaccine is now restricted to individuals aged ≥18 years for whom other authorized or approved vaccines against SARS-CoV2 infection are not accessible or are clinically inappropriate and to those in the same age group who choose to receive the Janssen COVID-19 vaccine because they would otherwise not receive one, according to the FDA statement.

The FDA determined the limitation is warranted based on an updated analysis, evaluation, and investigation of the risk of thrombosis with thrombocytopenia syndrome (TTS). The review included reported cases of TTS, a syndrome of potentially life-threatening blood clots and reduced platelets with symptoms presenting approximately 1 to 2 weeks after administration of the Janssen COVID-19 vaccine.

The FDA also decided, however, that known benefits of the vaccine for the prevention of COVID-19 do outweigh the potential risks for individuals aged ≥18 years, in situations where other vaccines are unavailable.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the US and across the global community,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA announcement. “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."

Marks added that the FDA's current steps reflect the agency's robust safety surveillance and its "commitment to ensuring that science and data guide our decisions. 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.”

Past, present, future

The US FDA granted emergency use authorization (EUA) to the Janssen COVID-19 vaccine in February 2021. The authorization was followed in April by a joint recommendation from the FDA and the Centers for Disease Control and Prevention (CDC) to pause administration of the vaccine to allow investigation of 6 reported cases of TTS and to make health care providers aware of the potential for the condition. Broad communication was important to help clinicians plan for recognition and clinical management given the unique treatment required for TTS. The pause was lifted after 10 days with the agencies confirming a total of 15 cases of TTS out of approximately 8 million doses of the vaccine administered at the time.

Subsequently, the CDC’s Advisory Committee on Immunization Practices (ACIP) made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen shot in all individuals aged ≥18 years.

The current decision to limit authorized use of the vaccine was based on the fact that the rates of TTS and related deaths have not decreased appreciably over time and that risk factors for the syndrome remain unknown. TTS also is associated with significant long-term morbidity and an elevated mortality rate.