Janssen (J&J) COVID-19 Vaccine

Introduction

• Janssen/J&J vaccine is of historic interest and at present is only recommended in very exceptional cases and for a primary series only.
• Limited availability in the US.
• Only a monovalent formulation was produced
• See COVID-19, Vaccines for general vaccine indications, efficacy, duration of protection, choice and interchangeability

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

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 booster dose of any kind or  >2 months after the last monovalent booster dose.

• Janssen/J&J booster doses are only indicated for recipients 18 years and age and older in very rare limited situations.

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.
• GBS following a previous Janssen/J&J dose.

• TTS following receipt of a previous Janssen dose (or other adenovirus vectored COVID-19 vaccines not currently authorized in the US (eg AstraZeneca).

   

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.

• History of GBS

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