- FDA has restricted the authorized use of the Johnson & Johnson/Janssen COVID-19 vaccine to individuals 18 and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or who elect to receive the Johnson & Johnson vaccine because they would otherwise not receive a COVID-19 vaccine.
- This limitation is due to the risk of thrombosis with thrombocytopenia syndrome (TTS) approximately one to two weeks following administration of the Johnson & Johnson/Janssen COVID-19 Vaccine.
- FDA’s Fact Sheet for Healthcare Providers Administering Vaccine now reflects the change to the authorized use of the Johnson & Johnson/Janssen COVID-19 vaccine and includes a warning statement.
- CDC’s expansion and strengthening of the country’s ability to monitor vaccine safety allows for the detection of safety issues that may not have been seen during the COVID-19 vaccine clinical trials.
- CDC scientists can now quickly study and determine whether there is a safety concern with a particular vaccine.
- Continue to communicate with your networks about COVID-19 vaccine safety monitoring systems for pregnant people, Vaccine Adverse Event Reporting System (VAERS), and v-safe.
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