Product Information

Indication

  • Individuals 18 years of age and older 

Dose

Primary Series

  • 0.5 ml single* dose given IM (preferably deltoid)

*Immunocompromised individuals should preferably receive 3 doses of mRNA vaccine for the primary series. NACI recommends that immunocompromised individuals who have received a Janssen dose should receive 1 mRNA dose at least 28 days following the Janssen dose to complete the primary series.

Booster Doses

  • The Ministry of Health recommends that individuals who received Janssen Jcovden™ as the primary series receive an mRNA vaccine (Pfizer-BioNTech Comirnaty™ or Moderna Spikevax™) booster dose 2 months or later after the Janssen dose.
  • Real-world evidence indicates that a booster dose of Janssen COVID-19 vaccine may not be as effective or immunogenic as a booster dose of an mRNA COVID-19 vaccine given as a homologous or heterologous booster. Janssen Jcovden™ may be used for those in whom other COVID-19 vaccines are contraindicated or who state their preference to receive Janssen after receiving all the information.
  • See COVID-19 Vaccine Doses, Eligibility, and Intervals for more details.

Adverse Events

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 events.

The most commonly reported adverse events included:  

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

Rare adverse events

  • Thrombosis with Thrombocytopenia Syndrome (TTS)
    • 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. The terminology of this syndrome has been evolving. In Canada, TTS following COVID-19 vaccination in combination with the presence of a specific biomarker is referred to as Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT), and is considered a subset of TTS.
    • Individuals who have experienced TTS following vaccination with a viral vector COVID-19 vaccine should not receive a subsequent dose of a viral vector COVID-19 vaccine. They may receive further doses of mRNA COVID-19 vaccines following consultation with their clinical team, which may include a hematologist.
  • Capillary Leak Syndrome
    • Very rare cases of capillary leak syndrome (CLS) have been reported following immunization with viral vector COVID-19 vaccines. Some affected patients had a previous diagnosis of CLS. CLS is a serious, potentially fatal condition characterized by acute episodes of limb edema, hypotension, hemoconcentration and hypoalbuminemia. Individuals with a history of CLS should not receive Janssen.
  • 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 Jcovden™. 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 Jcovden™. 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

  • Anti-SARS-CoV-2 monoclonal antibodies for treatment of COVID-19
    • Based on expert opinion, vaccination with COVID-19 vaccine should be delayed for at least 90 days after treatment with anti-SARS-CoV-2 monoclonal antibodies for treatment of COVID-19 infection, as this therapy may interfere with and delay response to the COVID-19 vaccine. The period of 90 days is based on the half-life of the therapy.
  • Evusheld™ (tixagevimab / cilgavimab) for pre-exposure prophylaxis of COVID-19
    • NACI recommends delaying administration of Evusheld™ for at least 14 days following COVID-19 vaccination.
    • Information regarding effect of Evusheld™ on future COVID-19 vaccination is not available and NACI recommends timing be assessed on a case-by-case basis in consultation with clinical experts.
References

 22 Jun 2022

  • Age
    • Janssen Jcovden™ 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 (TTS) 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
    • Janssen Jcovden™ 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 Jcovden™ 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 Jcovden™ 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 events of the vaccine or because of the underlying infection
    • to prevent potential transmission to others who are at the vaccine clinic/site (individuals should be following public health self-isolation recommendations) 
  • Breastfeeding/Immunocompromised/Autoimmune Conditions
    • These populations were excluded from the initial vaccine trials.
    • 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 or recombinant protein subunit vaccine (e.g. Novavax Nuvaxovid™) may be used if there are any contraindications to mRNA vaccine or if mRNA vaccine is not accessible.
References

01 Dec 2021

Current Infection

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

Past Infection

  • If acute symptoms have resolved, the individual can be vaccinated. Following public health self-isolation recommendations is suggested.
  • NACI has suggested intervals between SARS-Co-V-2 infection and COVID-19 vaccination.
    • Note that these are suggested, not required intervals. These intervals have not been recommended in Saskatchewan, but the Ministry of Health supports these recommendations.
    • Based on vaccine and immunology principles, longer intervals between infection and vaccination are expected to produce more robust and durable responses to the vaccine.
    • Because mRNA vaccines are preferred, see similar questions in Pfizer-BioNTech Comirnaty™ or Moderna Spikevax™ FAQs for more details.
References

26 Sep 2022

  • Janssen Jcovden™ 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

26 Sep 2022