Janssen (J&J) COVID-19 Vaccine

by David O. Freedman, M.D. last updated 2022-09-13 10:36:05.897565-04:00 © Antimicrobial Therapy, Inc.
Janssen/Johnson & Johnson, J&J, Ad26.COV2.S, Jcovden

Introduction

  • CDC vaccination recommendations updated as of Sept 1, 2022 for new bivalent booster vaccines
  • Janssen/J&J vaccine is of historic interest and at present is only recommended in very exceptional cases and for a primary series only
  • Only a monovalent formulation was produced
  • See COVID-19, Vaccines for general vaccine indications, efficacy, duration of protection, choice an

Vaccine

  • Type: non-replicating adenovirus vectored vaccine, monovalent.  Does not contain live SARS-CoV2 virus
  • Janssen (Johnson & Johnson) COVID-19 Vaccine  (Ad26.COV2.S)
    • Contains the same original strain spike protein sequence that is coded for by mRNA vaccines

Dose

COVID-19 vaccine products currently approved or authorized in the United States: Janssen
Age indication Vaccine composition Primary series
Dose Injection volume
>18 years and older Monovalent 5×1010 viral particles 0.5 mL

Schedule (normal host)

  • No longer included in CDC clinical guidelines for primary or booster doses
  • Recipients of a single primary series dose should receive 1 bivalent mRNA booster dose 2 months after completion of the primary series if no previous vaccine dose of any kind or  >2 months after the last monovalent booster dose.

Storage

  • Store as follows:
    • 2-8°C (36-46°F) for up to 3 mos (for shipping and use); -20°C (-4°F) for up to 2 yrs

Toxicities

Contraindications

  • Anaphylaxis or immediate allergic reaction (within 4h) to a previous dose of an mRNA vaccine or separately to a vaccine constituent including polyethylene glycol (PEG) or polysorbate. 
    • Do not vaccinate with any mRNA vaccine
  • History of a known diagnosed allergy to a vaccine component

Precautions

  • Immediate allergic reaction (within 4h) to any other vaccine or injectable therapy not related to a component of mRNA-COVID-19 vaccines or polysorbate.
  • Persons with a reaction to a vaccine or injectable therapy that contains PEG
  • Allergy-related contraindication to one type of COVID-19 vaccine is a precaution to the other types of COVID-19 vaccines
  • Defer vaccination until resolution of a moderate or severe acute illness, with or without fever

Not Contraindications

  • Food (including egg and gelatin), pet, insect, venom, environmental, latex, oral medications; any other history of anaphylaxis not related to vaccine or injectables.

Adverse Effects

  • TTS rate of 0.38 cases per 100,000 doses; the highest rate (1 case per 100,000 doses administered) is among females aged 30-49 years.
  • Similar case rates (0.45 cases per 100,000 doses administered)  in females aged 18-29 years, females aged 50-64 years, and males aged 40-49 years N Engl J Med. 2021; 384:1964.
  • No data yet on anaphylaxis, none in trials, contains polysorbate 80 related to PEG
  • Injection-site reactions (pain), fatigue, headache, fever, and weakness.
  • Avoid if possible if previous GBS especially males over 50. GBS approximately 8/million vaccinees compared to 1.7 baseline rate.

Special Populations

Pregnancy

  • Not currently listed as an option for a primary series during pregnancy

Immunocompromised / HIV

  • Immunocompromised ≥18 years who received this vaccine for a primary series dose are recommended to receive a second (additional) dose (≥4 weeks apart) using a monovalent mRNA vaccine and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) at least 2 months after the additional dose
  • Self-attestation to moderately or severely immunocompromised status is acceptable