Product Information

Indication

  • Individuals 18 years of age and older 

Dose

  • 0.5 ml single* dose given IM (preferably deltoid)
    • *Janssen single dose vaccine recipients are eligible for a booster dose 2 months or later following their vaccination. An mRNA COVID-19 vaccine (Pfizer-BioNTech Comirnaty™ or Moderna Spikevax™) will be used for the booster dose.
      • NACI recommends that individuals who received one dose of Janssen (Johnson & Johnson) COVID-19 vaccine may be offered a booster dose with mRNA COVID-19 vaccine at least 6 months following the Janssen dose.

    • *The Ministry of Health has authorized additional doses for individuals who are immunocompromised/clinically vulnerable and meet eligibility criteria; additional doses have also been authorized for travel purposes. See details of eligibility criteria/intervals of additional doses in Saskatchewan here.
  • There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 vaccine.

Adverse Effects

Only short to medium term data are available at this time. Most adverse reactions occurred within 2 days following vaccination, were mild to moderate in severity, and of short duration (2 to 3 days). Surveillance will continue for long-term adverse effects.

The most commonly reported adverse effects included:  

  • injection site pain
  • headache
  • fatigue
  • myalgia
  • nausea

Rare adverse effects

  • VITT
    • The combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been reported post-market following vaccination with viral vector COVID-19 vaccines. This adverse event is being referred to as Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT).
  • Guillain-Barré Syndrome
    • Very rare events of demyelinating disorders, such as Guillain-Barré Syndrome (GBS), have been reported following vaccination with viral vector COVID-19 vaccines during post-authorization use.
  • Immune Thrombocytopenia (ITP)
    • Very rare cases of ITP have been reported following receipt of Janssen (Johnson & Johnson) COVD-19 Vaccine. This differs from VITT in that these cases were not associated with thrombosis.
  • Venous Thromboembolism (VTE)
    • Rare cases of VTE have been reported following receipt of Janssen (Johnson & Johnson) COVD-19 Vaccine. This differs from VITT in that these cases were not associated with thrombocytopenia.
    • The risk of VTE should be considered for individuals who are at increased risk for thromboembolism before receiving this vaccine.

Drug Interactions

  • There are no known drug interactions. 
References

 01 Dec 2021

  • Age
    • Janssen (Johnson & Johnson) Covid-19 vaccine is approved for use in persons 18 years of age and older. 

  • Reported hypersensitivity to one of the ingredients. See product monograph for ingredients.
    • In individuals with a confirmed severe immediate allergic reaction (e.g., anaphylaxis) to a component of this vaccine or its container, consultation with an allergist is recommended before receiving the vaccine.
    • Polysorbate 80 is a potentially allergenic ingredient.

  • Individuals with a history of the following conditions should not receive this vaccine:
    • heparin-induced thrombocytopenia (HIT)
    • thrombosis associated with lupus anticoagulant (thrombotic antiphospholipid syndrome)
    • major venous or arterial thrombosis with thrombocytopenia following viral vector COVID-19 vaccine
    • capillary leak syndrome

  • It is recommended individuals with a history of cerebral venous sinus thrombosis (CVST) with thrombocytopenia only receive this vaccine if benefit outweighs risk; mRNA COVID-19 vaccine is preferred.

  • For individuals with a history of immune thrombocytopenia, platelet monitoring may be recommended following vaccination with a viral vector vaccine.

  • The risk of venous thromboembolism should be considered for individuals who are at increased risk for thromboembolism before receiving this vaccine.

  • Pregnancy
    • As of May 21, 2021, Janssen (Johnson & Johnson) Covid-19 vaccine is not to be routinely offered to pregnant individuals and instead these individuals should receive mRNA vaccines (i.e. Pfizer-BioNTech Comirnaty™, Moderna Spikevax™). 
      • Janssen (Johnson & Johnson) Covid-19 vaccine can be offered if:
        • allergy to any of the mRNA vaccine components, or
        • mRNA vaccine is not readily available
      • The reason for this recommendation is concerns about increased complexity in medical care if Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) were to occur following a viral vector vaccine.
    • Receipt of Janssen (Johnson & Johnson) Covid-19 vaccine during pregnancy is not a reason to terminate pregnancy.

  • Currently feeling unwell with symptoms that could be COVID-19.
    • to avoid confusion if symptoms arise/worsen as they could be adverse effects of the vaccine or because of the underlying infection
    • to prevent potential transmission to others who are at the vaccine clinic/site (clients should be following public health quarantine recommendations) 
  • Breastfeeding/Immunocompromised/Autoimmune Conditions
    • These populations were excluded from the initial vaccine trials such that we had no data on safety and efficacy of the vaccines in these populations when vaccination started and decisions were based on risk-benefit assessments.
    • Based on real world data indicating COVID-19 vaccines are safe in these populations, NACI’s recommendations for COVID-19 vaccination in these populations are now the same as those for the general adult population, which is to receive a complete series of mRNA vaccine.  
      • Regarding special populations, most of the data have come from mRNA vaccines.
      • However, viral vector vaccine should be used if there are any contraindications to mRNA vaccine or if mRNA vaccine is not accessible.
References

01 Dec 2021

Current Infection

  • Clients with current infection should not present for vaccination to prevent transmission to others at the vaccination clinic/site and should follow public health quarantine recommendations.

Past Infection

  • If acute symptoms have resolved and all quarantine orders have been followed, the client can be vaccinated.
Reference

26 Oct 2021

  • Previous direction had been to separate COVID-19 vaccine from all other vaccines based on limited safety, reactogenicity and immunogenicity evidence.

  • The Ministry of Health is authorizing COVID-19 vaccine to be administered concomitantly with other vaccines; no intervals are required before or after COVID-19 vaccine administration and another vaccine.
    • The Ministry of Health closely monitored simultaneous administration of COVID-19 and other vaccines as implemented in other jurisdictions over the past few months. No additional safety risks or adverse events following immunization have been identified by simultaneous administration of these vaccines.
    • This directive ensures that individuals have the opportunity to be immunized against COVID-19 when they are eligible to receive other vaccines such as influenza and school-aged vaccines.

  • NACI recommends that, in adolescents and adults, COVID-19 vaccines may be given at the same time as, or any time before or after, other vaccines, including live, non-live, adjuvanted or unadjuvanted vaccines
  • Separate injection sites should be used when administering > 1 vaccine
    • Preferably use two different limbs but if need to inject >1 vaccine into the same limb, separate the two injection sites by at least 2.5 cm (1 inch).
References

01 Dec 2021