Moderna Spikevax™ (Royal Blue Cap)

≥ 6 Months to < 6 Years (25 mcg / 0.25 mL)

This information applies only to Moderna Spikevax™ (Royal Blue Cap) to provide doses of 25 mcg to children 6 months to < 6 years old. Refer to Moderna Spikevax™ (Red Cap) for use in those ≥ 6 years old.


NOTE: Moderna Spikevax™ Royal Blue Cap 25 mcg / 0.25 mL has been approved for use in individuals 6 months of age and older; however, at this time, this formulation is only being used in those ≥ 6 months to < 6 years of age in Saskatchewan. 

Product Information

Indication

  • Individuals ≥ 6 months to < 6 years of age
† While this product is Health Canada-approved for all individuals 6 months of age and older, it will only be used in individuals ≥ 6 months to < 6 years of age in Saskatchewan.

NOTE: NACI and the Ministry of Health recommend Pfizer-BioNTech Comirnaty™ (Orange Cap; 10 mcg) in 5-year-old children (both products are approved for this age), though Moderna Spikevax™ (Royal Blue Cap; 25 mcg) can be offered to children in this age group if requested.

Dose

Primary Series

  • 2* x 0.25 ml (25 mcg mRNA) doses given IM (generally vastus lateralis if < 12 months of age; deltoid if ≥ 12 months of age) – Moderna Spikevax™ Red Cap (100 mcg/0.5 mL) is NOT to be used for this dose
    • In Saskatchewan, the 2nd dose should be given at least 8 weeks after the 1st dose.
      • This longer interval is expected to result in a more robust and durable immune response.
      • The Health Canada approved interval is at least 4 weeks after the 1st dose; the recommended interval in Saskatchewan may change when vaccine supply permits.
* Moderately to severely immunocompromised individuals should receive 3 doses for the primary series at intervals of 4 to 8 weeks between doses.

  • It is recommended that children who received Moderna Spikevax™ 25 mcg as a 1st dose and are 6 years old when they present for their 2nd dose, preferably complete the series with Moderna Spikevax™ Red Cap 50 mcg. However, if Moderna Spikevax™ Royal Blue Cap 25 mcg or Pfizer-BioNTech Comirnaty™ Orange Cap 10 mcg is given, the dose does not need to be repeated and the primary series is considered complete.

NOTE: If any interval is longer than recommended, there is no reason to restart the series. Provide the next dose as soon as possible.

Booster Doses

  • Children under 5 years of age are not yet eligible for a booster dose.
  • Children ≥ 5 years to < 12 years are eligible for a booster dose but only with Pfizer-BioNTech Comirnaty™ 10 mcg (Orange Cap). Moderna Spikevax™ is not to be used as booster doses for children < 12 years.

Adverse Events

  • Only short- to medium-term clinical trial data are available at this time. Surveillance will continue for long-term adverse events.
  • Reported adverse events were mild or moderate, more common following the 2nd dose, and generally resolved within 2-3 days.
  • Common adverse events included: 
    • Children ≥ 6 months to < 2 years of age
      • irritability/crying
      • local reactions: pain at injection site, redness, and swelling
      • loss of appetite
      • fever
    • Children ≥ 2 years to <6 years of age
      • irritability/crying
      • local reactions: pain at injection site, redness, and swelling
      • loss of appetite
      • fatigue
      • fever
      • headache
      • nausea/vomiting
      • chills
  • Rare Adverse Events
    • No cases of myocarditis, pericarditis, vaccine-related anaphylaxis, or multisystem inflammatory syndrome in children (MIS-C) were reported. However, these would not be expected given the size of the trial and will continue to be monitored.

Drug Interactions

  • There are no known drug interactions with medications used in this age group.
References
Last Updated

06 Sep 2022

  • < 6 Months or ≥ 6 Years of Age
    • This formulation of Moderna Spikevax™ is Health Canada approved for use in individuals 6 months and older; however, in Saskatchewan, it will only be used for individuals ≥ 6 months to < 6 years of age.
  • 5-Year-Old Children
    • According to Health Canada authorizations, 5-year-old children are eligible for two COVID-19 vaccines: Moderna Spikevax™ (Royal Blue Cap; 25 mcg) and Pfizer-BioNTech Comirnaty™ (Orange Cap; 10 mcg).
    • NACI and the Ministry of Health recommend Pfizer-BioNTech Comirnaty™ (Orange Cap; 10 mcg) for children who are 5 years old.
    • Only Pfizer-BioNTech Comirnaty™ 10 mcg (Orange Cap) is to be used for booster doses in children who are 5 years old.

  • Serious adverse or allergic reaction to previous dose of COVID-19 vaccine unless determined safe by an allergist or other healthcare provider. As per the Ministry of Health:
    • 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 usual 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.

  • Currently feeling unwell with symptoms that could be COVID-19 infection so as to:
    • avoid confusion if symptoms worsen as they could be adverse events of the vaccine or because of the underlying infection; and
    • prevent potential transmission to others who are at the vaccine clinic/site (individuals should be encouraged to follow public health self-isolation recommendations).

  • NOTE: Certain populations were excluded from the initial vaccine trials including those who are severely immunocompromised/immunosuppressed ans those with autoimmune conditions.
    • Considerations for children who are moderately to severely immunocompromised because of a condition or medications:
      • These individuals are at higher risk of contracting SARS-CoV-2 and higher risk of more severe complications of COVID-19.
      • Based on evidence in older age groups, individuals who are moderately to severely immunocompromised have a lower vaccine response than the general population. Individuals need to continue to take precautions against SARS-CoV-2 infection.

    • Based on evidence in older age groups, 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).

  • History of Myocarditis or pericarditis
    • History of myocarditis or pericarditis following mRNA COVID-19 vaccination
      • As a precautionary measure, further doses of mRNA COVID-19 vaccine should be deferred in most individuals who developed myocarditis or pericarditis following the first dose of an mRNA COVID-19 vaccine until more information is available.
    • History of myocarditis or pericarditis unrelated to mRNA COVID-19 vaccination
      • Children who have a history of myocarditis and/or pericarditis unrelated to mRNA COVID-19 vaccination should consult their clinical team for individual considerations and recommendations.
        • If they are no longer being followed clinically for cardiac issues, they may receive the vaccine. 

  • History of Multisystem Inflammatory Syndrome in Children (MIS-C)
    • COVID-19 vaccination in individuals with a history of MIS-C should be delayed until clinical recovery or until ≥ 90 days since diagnosis, whichever is longer.
References
Last Updated

21 Jul 2022

Current Infection

Past Infection

  • Based on NACI recommendation and limited supply of vaccine:
    • Non-immunocompromised children: delay vaccination for at least 8 weeks following symptom onset or positive test (if asymptomatic).
    • Moderately to severely immunocompromised children: delay vaccination for at least 4 to 8 weeks following symptom onset or positive test (if asymptomatic).
References
Last Updated

21 Jul 2022

  • Moderna Spikevax™ (Royal Blue Cap) will be available through clinics operated by SHA as well as Indigenous Services Canada and Northern Inter-Tribal Health Authority.
  • Moderna Spikevax™ (Royal Blue Cap) is NOT available at pharmacies.
Reference
Last Updated

21 Jul 2022