The US FDA has limited the authorized use of the Johnson & Johnson Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to 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.
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 syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.
The Janssen COVID-19 Vaccine was authorized for emergency use on Feb. 27, 2021. On April 13, 2021, the FDA and the CDC, announced a recommended pause in administration of the vaccine to investigate six reported cases of TTS, and to help ensure that health care providers were made aware of the potential for TTS and could plan for proper recognition and management due to the unique treatment required for TTS.
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. 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 approximately 8 million doses administered.
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 Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine 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.
“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. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. 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.”