After conducting an updated analysis, evaluation and investigation of reported cases, the US Food and Drug Administration (FDA) said it has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS)of the Janssen COVID-19 Vaccine warrants limiting the authorized use of the vaccine.
“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. 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, director of the FDA’s Center for Biologics Evaluation and Research.
He said the move demonstrates the robustness of the FDA’s safety surveillance systems and its commitment to ensuring that science and data guide its decisions.
The agency will continue to monitor the safety of the Janssen vaccine, added Marks.
Examples of individuals who may still receive the Janssen shot include people who experienced an anaphylactic reaction after receipt of an mRNA COVID-19 vaccine, those who have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine and people who would remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines.
The factors that put an individual at risk for TTS following administration of Janssen COVID-19 vaccine remain unknown, said the FDA.
In making its decision to restrict the use of the Janssen shot, the agency said it also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences and that TTS has a high death rate.
The Janssen COVID-19 vaccine was authorized for emergency use in the US in February last year.
However, on April 13, 2021, the FDA and the US Centers for Disease Control and Prevention (CDC), announced a recommended pause in administration of the vaccine to investigate six reported cases of TTS.
On April 23 last year, following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA and the CDC lifted the recommended pause regarding the use of shot. The agencies confirmed 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 around 8 million doses administered.
In December 2021, after reviewing updated vaccine effectiveness and safety data, the ACIP made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen shot in all persons 18 years of age and older in the US.