Based on concerns about the increased incidence of thrombosis with thrombocytopenia (TTS) in people who received the Janssen/Johnson & Johnson (J&J) COVID-19 vaccine, an advisory committee of the US Centers for Disease Control and Prevention (CDC) recommended that COVID-19 vaccines other than Johnson & Johnson’s be preferred. The CDC states that the US TTS case reporting rate following Janssen COVID-19 vaccination is higher than previously presented.
The TTS risk is estimated to occur in 1 in 100,000 people who received the vaccine. The FDA issued an updated fact sheet for the Janssen/J&J vaccine reflecting concern about the TTS risk linked to the vaccine. The Janssen/J&J COVID-19 vaccine should not be administered to individuals with a history of TTS following receipt of this vaccine or any other adenovirus-vectored COVID-19 vaccines, according to a newly revised FDA vaccine fact sheet.
Reports from the Vaccine Adverse Events Reporting System (VAERS) show that the onset of symptoms occurred approximately 1 to 2 weeks after administration of the Janssen COVID-19 vaccine. Cases were reported in both males and females, with approximately 15% of cases being fatal. The highest rate was reported in females 30 to 49 years of age.