Due to potential for rare but serious blood clots, the FDA has limited emergency use authorization (EAU) for Janssen’s COVID-19 vaccine.

• The vaccine initially received an EUA in February 2021 to prevent COVID-19 in individuals at least 18 years of age. It is now only authorized to prevent COVID-19 in:
  • Individuals at least 18 years old for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate.
  • Individuals at least 18 years old who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
• The FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but life-threatening condition observed in some recipients of the vaccine, warrants limiting the product’s authorized use.