Product Information

Janssen COVID-19 Vaccine - product monograph

Indication

  • Individuals 18 years of age and older 

Dose

  • 0.5 ml single dose given IM (preferably deltoid)

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

Drug Interactions

  • There are no known drug interactions. 

 

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

    • History of anaphylaxis following previous dose of the vaccines.

    • Reported hypersensitivity to one of the ingredients. See product monograph for ingredients.
    • 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)
      • venous or arterial thrombosis with thrombocytopenia following viral vector COVID-19 vaccine

    • 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.

    • Pregnancy
      • As of May 21, 2021, Janssen Covid-19 vaccine is not to be routinely offered to pregnant individuals and instead these individuals should receive mRNA vaccines (i.e. Pfizer-BioNTech, Moderna). 
        • Janssen 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 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)

    • Serious adverse or allergic reaction to previous dose of COVID-19 vaccine unless determined safe by an allergist or other healthcare provider.

     

    References:

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.
  • Previous direction had been to separate COVID-19 vaccine from all other vaccines based on limited safety, reactogenicity and immunogenicity evidence.
  • As of September 2, 2021, 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.
    • 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).
    • Note that NACI continues to recommend separating COVID-19 vaccine from other vaccines and continues to monitor the evidence.
    • Minimum intervals between two COVID-19 vaccine doses are still required.
References:

 

  • 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.
  • However, NACI suggests Janssen COVID-19 vaccine may be used to complete an AstraZeneca COVID-19 vaccine series if AstraZeneca is not available. 
    • NOTE: currently Janssen COVID-19 vaccine is not available in Saskatchewan.

References: