VACCINE TYPE

• Janssen’s COVID-19 Vaccine is no longer available in the U.S.
  • All remaining U.S. government stock of Janssen COVID-19 Vaccine expired May 7, 2023.
  • Any remaining Janssen COVID-19 Vaccine should be disposed of per local, state, and federal regulations.
• The Janssen COVID-19 vaccine is a suspension of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the SARS-CoV-2 spike (S) protein in a stabilized conformation.
  • Single intramuscular (IM) dose to be given to patients 18 and older.
• The U.S. FDA issued an Emergency Use Authorization (EUA) to permit the emergency use of the Janssen COVID-19 vaccine for active immunization to prevent COVID-19 in individuals 18 and older.
  • On May 5, 2022, the FDA revised the criteria for the EUA, limiting the vaccine’s use due to the perceived risk of thrombosis with thrombocytopenia syndrome (TTS) within 1 - 2 weeks after receipt of the vaccine.
    • Use of the Janssen COVID-19 vaccine is limited to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
  • Mandatory requirements for the administration of the Janssen vaccine under the EUA are as follows:
    • The vaccine is authorized in patients ≥ 18 years of age.
    • The vaccination provider must give the individual receiving the Janssen vaccine or their caregiver the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving the Janssen vaccine.
    • Vaccine providers must include vaccine information in the state’s or local jurisdiction’s Immunization Information System or other designated systems.
    • Vaccine providers are responsible for reporting certain events to the Vaccine Adverse Events Reporting System (VAERS):
      • Vaccine administration errors, whether or not associated with an adverse event
      • Serious adverse events include death, life-threatening events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, and congenital anomalies/birth defects.
      • Cases of multisystem inflammatory syndrome (MIS) in children and adults
      • Cases of COVID-19 that result in hospitalization and death
    • Vaccine providers are responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following the administration of the Janssen vaccine.
  • The CDC recommended that anyone 18 or older be given a booster shot at least 2 months after the initial dose.
    • Booster doses should be provided with one of the mRNA vaccines (Pfizer BioNTech or Moderna)
    • On March 29, 2022, the CDC recommended that a second booster dose with an available mRNA vaccine be provided 4 months after the initial booster.