Janssen (J&J) COVID-19 Vaccine

Janssen/Johnson & Johnson, J&J, Ad26.COV2.S

Administration

Vaccine

  • Janssen COVID-19 Vaccine. Ad26.COV2.S

Authorized for Use in

  • US FDA (not considered as a preferred vaccine), Health Canada, EU EMA, UK, WHO EUL, Australia TGA.  

Age

  • >18 years

Type

  • Non-replicating adenovirus vector

Primary Dosing

  • 0.5 mL IM (5 X 1010 virions) x 1 dose.
  • Moderate and severe immunocompromise: additional primary dose with an mRNA vaccine at least 28 days after the primary dose
  • Persons age 5-18 yrs: Not approved in this age group

First Booster Dosing

  • US guidelines presented; wide national variations regarding boosters.
  • 0.5 mL IM (same as dose 1) given at least 2 months after the first Janssen/J&J dose—may be give to persons aged ≥ 18 years. mRNA booster at least 2 months after the first Janssen/J&J dose is preferred. 
  • Moderate and severe immunocompromise: booster (third dose) at least 2 months after the additional dose but an mRNA vaccine is preferred for this dose in previous initial Janssen/J&J vaccinees whether 1 or 2 previous Janssen/J&J doses received. 
  • WHO EUL recommendation. Booster at 4-6 months after dose 2. Consider EUL mRNA vaccine for 2nd primary or subsequent booster doses. 
  • Three doses of mRNA vaccine is the only current effective strategy against the Omicron variant; no data yet on heterologous dosing with Janssen/J&J and subsequent mRNA boosters

Optional Second Booster Dosing

  • US guidelines presented; wide national variations regarding boosters. These CDC recommended options are without formal ACIP review. Supporting clinical data limited to 1 Israeli cohort over age 60
  • Optional:  May choose to boost with the indicated booster dose of an mRNA vaccine in healthy persons aged ≥ 50 years, 4 months after the first booster dose whether that booster dose was mRNA or Janssen/J&J. Dose 3 in these persons.
  • Optional: Healthy persons aged 18-49 years who received the Janssen/J&J vaccine as both their primary series dose and first booster dose may receive a second booster dose using an mRNA vaccine at least 4 months after the Janssen/J&J booster dose.  Dose 3 for these persons.
  • Optional:  May choose to boost with the indicated booster dose of an mRNA vaccine in moderately and severely immunocompromised persons aged ≥18, 4 months after the first booster dose whether 1 or 2 previous Janssen/J&J doses received.  Dose 4 for this population
  • WHO EUL recommendation--subsequent boosters not yet considered.

Interchangeability

  • CDC recommends that persons aged ≥ 18 years (including moderately or severely immunocompromised persons who received an additional primary dose) who were fully vaccinated with a WHO EUL vaccine not authorized/approved by US FDA or with a heterologous series composed of any FDA-authorized/approved or WHO EUL authorized vaccine are eligible to receive a single booster dose of the Pfizer vaccine (0.3 mL; 30 µg) at least 6 months after completion of their primary series under the existing age guidelines as for Moderna and Pfizer vaccines. Practically, either mRNA vaccine may be used for a booster in this situation.

Special Situation:

  • Many recipients of Janssen/J&J vaccine may have received a booster dose (Pfizer, Moderna [50 µg], or Janssen/J&J vaccine), without having had the second (additional) mRNA vaccine dose. In this situation, regardless of type and timing of vaccine received as the second dose, administer a Pfizer vaccine or a Moderna vaccine (100 µg) as the third (additional) dose at least 2 months after dose 2. 

Storage

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

Efficacy

Overall against symptomatic disease

  • 76% (US trial); 66.9% (US, Brazil, South Africa combined)
    • Overall efficacy against symptomatic disease in Phase 3 trials was pre-delta. Specific vaccine efficacy (VE) data against beta, gamma no longer relevant.

Real world against hospitalization

  • VE by vaccine (delta era): against hospitalization Moderna 95%, Pfizer 80%, J&J 60%. Poor efficacy of Janssen/J&J in South Africa asgainst beta. Waning immunity against hospitalization for delta very significant for >65 years of age.

Age > 65 years

  • 66.10%

Pediatric

  • Not approved

Against severe disease / death

  • 85.4% vs severe / critical; 100% against death in Phase 3. 81% VE against beta. Real world predelta: 68% against hospitalization and 73% against an emergency department or urgent care visit.

Against asymptomatic infection / transmission

  • Delta variant results in peak viral loads 1,000 times higher than the alpha variant and is equal between vaccinated and unvaccinated persons, but virus is cleared more rapidly in vaccinated
    persons.

Duration of efficacy after final dose

  • Durable humoral and cellular immune responses with minimal decreases for at least 8 months in pre-delta subjects. Few data with this vaccine. Duration against delta and omicron variants especially in
    immunocompromised and elderly is unknown and of concern.

Toxicities

Contraindications

Precautions

  • Same as Pfizer BioNTech mRNA and Moderna mRNA plus persons with a contraindication to mRNA COVID-19 vaccines (including allergy to PEG) have a precaution to the Janssen/J&J vaccine (cross-reactive polysorbate 80) and vice-versa.

Not contraindications

Adverse effects

  • Among 16.9 million Janssen/J&J vaccinees in the US 57 cases (including 9 deaths) of TTS following the primary dose of the Janssen/J&J vaccine have been reported in males (17 cases) and females (37 cases) aged ≥ 18 years, with an overall 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 (.45 cases per 100,000 doses administered) were observed in females aged 18-29 years, females aged 50-64 years, and males aged 40-49 years.Treat with oral anticoagulants and IVIG. No heparin for any thrombotic event withing 2 weeks of vaccination without negative anti-PF4 result. 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 Needs Populations

Pregnancy

  • Use. No reproductive or development concerns (preliminary); risk of disease effect > known vaccine risk; endorsed for use by ACOG. VSD data with insufficient numbers

Immunocompromised / HIV

  • Moderate and severe immunocompromise: booster (third dose) at least 2 months after the additional dose but an mRNA vaccine is preferred for this dose in previous initial Janssen/J&J vaccinees whether 1 or 2 previous Janssen/J&J doses received. No additional doses recommended 3 months later as with mRNA vaccine.