Product Monograph
Indication
  • Individuals 12 years of age and older
Dose
  • Primary Series
    • 2* x 0.5 ml (100 mcg mRNA) doses given IM (deltoid)
      • The 2nd dose should be given at least 28 days after the 1st.
        • The manufacturer recommends a 28-day interval.
        • The Ministry of Health recommends an 8-week interval; however 28 days is acceptable.
        • NACI advises an interval of at least 8 weeks between the 1st and 2nd doses is optimal.
          • Local transmission of the SARS-CoV-2 virus; the degree of individual risk of exposure to the virus; and the need of a second dose for earlier protection should be considered when deciding the interval.
          • Individuals who completed their primary vaccine series using manufacturer-authorized intervals also have very good protection against severe COVID-19 disease and do not need to restart their vaccine series.
        • Based on NACI recommendation, the minimum interval is 21 days between doses (any doses provided at an earlier interval would be considered invalid and need to be repeated).
          • This interval is not a recommended interval and should only be used to determine dose validity.

    • *The Ministry of Health has authorized additional doses for individuals who are immunocompromised/extremely clinically vulnerable and who meet eligibility criteria; additional doses have also been authorized for travel purposes. See details of eligibility criteria/intervals of additional doses in Saskatchewan here.

  • Booster Dose
    • The Ministry of Health has authorized booster doses for individuals meeting eligibility criteria. See details of eligibility criteria in Saskatchewan here.
    • See Primary Series for immunocompromised individuals.    

Table: Moderna Spikevax™ Booster Doses

Residents of Long-Term Care (Special Care Homes), Personal Care Homes and Seniors’ Assisted Living, regardless of age 0.5 mL (100 mcg mRNA)
Individuals 70 years and older
Immunocompromised individuals (those who received a 3-dose primary series)
All others eligible for booster dose 0.25 mL (50 mcg mRNA)
 
  • If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.
Adverse Effects
  • Only short-term data are available at this time. Surveillance will continue for long-term adverse effects. 
  • Reported adverse effects were mild or moderate, resolved within a few days and included: 
    • pain at the injection site
    • fatigue
    • headache
    • myalgia
    • chills
  • Adverse effects were more common following the 2nd dose.
  • Rare Adverse Effects
    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with COVID-19 vaccines have been reported in a small number of people. Most cases followed vaccination with mRNA COVID-19 vaccine.
      • Symptoms can include chest pain, shortness of breath, or palpitations (feelings of having a fast-beating, fluttering or pounding heart). In many cases, these conditions are mild and require little to no treatment. However, more severe cases can lead to heart muscle damage.
      • Health Canada has issued a statement regarding updates to Pfizer-BioNTech Comirnaty™ and Moderna Spikevax™ labels.
    • Bell’s palsy / facial paralysis was reported in three recipients in the vaccine group compared to one in the placebo group in the clinical trial. It typically presents as sudden weakness or paralysis on one side of the face and generally starts to improve within a few weeks.
Drug Interactions
  • There are no known drug interactions. 
References

20 Dec 2021

  • Serious adverse or allergic reaction to previous dose of COVID-19 vaccine unless determined safe by an allergist or other healthcare provider.
    • It is possible for individuals who experienced a severe immediate allergic reaction (e.g. anaphylaxis) after a first dose of an mRNA COVID-19 vaccine to safely receive future doses of the same or another mRNA COVID-19 vaccine in a controlled setting after consulting with an allergist or another appropriate physician if risk assessment deems benefits outweigh risks for the individual and informed consent is provided.
    • Individuals with a history of severe immediate allergic reaction following a dose of an mRNA COVID-19 vaccine should:
      • Consult with an allergist or another appropriate physician before receiving future doses of an mRNA COVID-19 vaccine;
      • Receive future doses of an mRNA COVID-19 vaccine in a controlled setting with someone who is experienced in managing anaphylaxis; and
      • Be observed for at least 30 minutes after vaccination (the normal observation period for people who have not experienced a severe immediate allergic reaction after vaccination is 15 minutes).

  • 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.
    • Polyethylene glycol (PEG) and tromethamine are potentially allergenic ingredients.
    • See the Health Canada recommendations for people with serious allergies.

  • Currently feeling unwell with symptoms that could be COVID-19 infection.
    • to avoid confusion if symptoms 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 encouraged to follow public health quarantine recommendations)

  • History of myocarditis or pericarditis
    • As a precautionary measure, NACI recommends the second dose should be deferred in individuals who experienced myocarditis or pericarditis following an mRNA COVID-19 vaccine until more information is available.
    • Individuals who have a history of myocarditis unrelated to mRNA COVID-19 vaccination should consult their clinical team for individual considerations and recommendations. If they are no longer followed clinically for cardiac issues, they may receive the vaccine.
  • NOTE: Certain populations were excluded from the initial vaccine trials including pregnancy, breastfeeding, immunocompromised/immunosuppressed, and autoimmune conditions.
    • When vaccinations began, we had no data on safety and efficacy of the vaccines in these populations.
    • However, 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 and to complete a series initiated with AstraZeneca Vaxzevria™ with mRNA vaccine.   
    • Those who are immunocompromised have shown lower immune responses to the COVID-19 vaccines compared to those who are immunocompetent; it is not known if this will translate into less effectiveness in terms of severity of symptoms, hospitalizations and death, but it is a possibility and these individuals will need to continue to take precautions against COVID-19 disease. The possibility of reduced immune response in those who are immunocompromised exists for most vaccines.
    • Those with autoimmune conditions have shown similar safety and immune response compared to those without autoimmune conditions. Those taking immunosuppressive therapy showed diminished immune response (see above bullet).
    • Regarding pregnancy, the emerging safety and immunogenicity data of COVID-19 vaccines have found:
      • No maternal or neonatal safety signals have been raised. These data have been derived from:
        • International immunization registries
        • Preliminary analyses of > 35,000 pregnant women in the US who received mRNA vaccine
      • Data are available indication mRNA vaccination in pregnant individuals results in comparable antibody titres to those generated following mRNA vaccination in non-pregnant individuals.
      • Maternal IgG humoral response to mRNA COVID-19 vaccines transfers across the placenta to the fetus, leading to a significant and potentially protective, antibody titre in the neonatal bloodstream one week after the second dose.
    • Regarding breastfeeding, the emerging safety data of COVID-19 vaccinations have found:
      • Both anti-spike IgG and IgA are present in breastmilk after maternal vaccination with mRNA vaccines.
      • mRNA from COVID-19 vaccines was undetectable in breastmilk 4-48 hours post-vaccination in one small cohort study.
References

09 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

19 Apr 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

30 Nov 2021