- 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 Johnson & Johnson 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 Johnson & Johnson 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 Johnson & Johnson 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.
The Johnson & Johnson Janssen COVID-19 Vaccine was authorized for emergency use on Feb. 27, 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention (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.
The FDA and CDC have continuously monitored for and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Johnson & Johnson Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.
In making the determination to limit the authorized use of the Johnson & Johnson Janssen COVID-19 Vaccine, the agency considered that reporting rates of TTS and TTS deaths following administration of the Johnson & Johnson Janssen COVID-19 Vaccine are not appreciably lower than previously reported. Furthermore, the factors that put an individual at risk for TTS following administration of Johnson & Johnson Janssen COVID-19 Vaccine remain unknown. The FDA 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 agency also considered the availability of alternative authorized and approved COVID-19 vaccines which provide protection from COVID-19 and have not been shown to present a risk for TTS.
Remnant Editor's Comment: One down, two to go.
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