The Janssen COVID-19 vaccine should not be administered to individuals with a history of thrombosis with thrombocytopenia (TTS) following receipt of this vaccine or any other adenovirus-vectored COVID-19 vaccines (eg, AstraZeneca’s COVID-19 vaccine), according to the revised fact sheet.
The new contraindication was announced by the Food and Drug Administration (FDA) based on evidence of an increased risk of TTS. An analysis of reports from the Vaccine Adverse Events Reporting System (VAERS) shows that the onset of symptoms occurred approximately 1 to 2 weeks after administration of the Janssen COVID-19 vaccine.
Cases of TTS have been reported in both males and females, with the highest reporting rate (approximately 1 case per 100,000 doses) in females 30 to 49 years old. Approximately 15% of these cases have been fatal.
At this time, the FDA still believes that the benefits of the vaccine continue to outweigh the risks; an investigation into the level of potential excess risk is ongoing.
US Food and Drug Administration. FDA Coronavirus (COVID-19) Update: December 14, 2021. Accessed December 15, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-14-2021.