FDA Revises Janssen Covid Vaccine Fact Sheets

FDA says there are revisions to two fact sheets for the Janssen (Johnson & Johnson) Covid-19 vaccine. An agency announcement says the Fact Sheet for Healthcare Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers 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. The sheets also update the information about the risk of thrombosis with thrombocytopenia syndrome following vaccination.

The notice says the agency and the Centers for Disease Control continue to investigate the level of potential excess risk and FDA continues to find that the known and potential benefits of the Janssen vaccine outweigh its known and potential risks to individuals age 18 and older.