Johnson & Johnson COVID-19 Vaccine

Kathryn Dzintars, Pharm.D., BCPS
Johnson & Johnson COVID-19 Vaccine is a topic covered in the Johns Hopkins HIV Guide.

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VACCINE TYPE

  • The Janssen COVID-19 vaccine is a suspension consisting 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 years of age 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 years of age and older.
    • 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 Janssen vaccine.
      • Vaccine providers must include vaccine information to either 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 including death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, congenital anomaly/birth defects
        • Cases of the 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 administration of Janssen vaccine to recipients.

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VACCINE TYPE

  • The Janssen COVID-19 vaccine is a suspension consisting 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 years of age 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 years of age and older.
    • 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 Janssen vaccine.
      • Vaccine providers must include vaccine information to either 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 including death, life-threatening adverse events, inpatient hospitalization/prolonged hospitalization, persistent or significant incapacity, congenital anomaly/birth defects
        • Cases of the 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 administration of Janssen vaccine to recipients.

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Last updated: March 11, 2021