Fact Sheets Updated for Janssen COVID-19 Vaccine
The U.S. FDA today announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Health Care Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers.
The fact sheets now include a contraindication to the administration of the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine.
And to update the information about the risk of thrombosis with thrombocytopenia syndrome or TTS following vaccination.
Cases of TTS following administration of the Janssen COVID-19 Vaccine have been reported in males and females 18 years of age and older.
The highest reporting rate of approximately one case per 100,000 doses administered in females 30-49 years of age; overall. About 1 out of 7 cases have been fatal.
On December 9, 2021, the WHO's SAGE published a Version #9 overview.
TTS was reported as approximately 1 per 500,000 doses administered.
The majority of the cases (69%) were reported from the USA and in age groups below 65 years (83%), 55% in females.
The mean and median time-to onset of the event was about 12 days.
The FDA says 'individuals should speak to their healthcare provider to determine which COVID-19 vaccine is most appropriate for their situation.'
The FDA continues to find that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older.