Pfizer-BioNTech Comirnaty™ (Purple and Grey Caps)

≥ 12 Years (30 mcg / 0.3 mL)

This information applies only to Pfizer-BioNTech Comirnaty™ (Purple and Grey Caps) approved for those ≥ 12 years of age. For information about Pfizer-BioNTech Comirnaty™ (Orange Cap) for those ≥ 5 years to < 12 years of age, go here.
Product Information
Indication
  • Individuals 12 years of age and older.
Dose

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

Primary Series
  • 2* x 0.3 ml (30 mcg mRNA) doses given IM (deltoid)
    • The 2nd dose should be given at least 21 days after the 1st, which is the Health Canada approved interval.
      • The Ministry of Health recommends an 8-week interval; however 21 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 19 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.
*Moderately to severely immunocompromised individuals should receive 3 doses for the primary series with intervals of 4 to 8 weeks between all doses (though 21 days is acceptable between doses 1 and 2).

  • For children who received Pfizer-BioNTech Comirnaty™ (Orange Cap; 10 mcg) for one or more doses and are 12 years old when they present for a subsequent dose, complete the series with Pfizer-BioNTech Comirnaty™ 30 mcg (Purple or Grey Cap).

Booster Doses

Adverse Events 
  • Only short to medium term 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 a few days.
  • Common adverse events included:  
    • pain at injection site
    • fatigue
    • headache
    • muscle pain
    • chills
    • joint pain
    • fever
  • Rare Adverse Events
    • 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 four recipients in the vaccine group compared to none in the placebo group in the clinical trial. There have been rare cases reported postmarket in Canada and internationally. 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
  • Anti-SARS-CoV-2 Monoclonal Antibodies
    • For treatment of COVID-19 (e.g., sotrovimab)
      • 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.

    • For pre-exposure prophylaxis of COVID-19
      • Evusheld™ (tixagevimab / cilgavimab)  
        • 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

06 Sep 2022

  • Under 12 years of age
    • Pfizer-BioNTech Comirnaty™ is approved for use in persons 12 years of age and older.
    • A different formulation, Pfizer-BioNTech Comirnaty™ (Orange Cap), is approved for use in persons ≥ 5 years to < 12 years. See information here 
  • 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. Note the formulation of this vaccine differs from the formulation for those ≥ 5 years to < 12 years. 
    • 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) is a potentially allergenic ingredient.
    • See the Health Canada recommendations for people with serious allergies.

  • Currently feeling unwell with symptoms that could be COVID-19 so as to:
    • avoid confusion if symptoms arise/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 following public health self-isolation recommendations).

  • 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 (with or without pericarditis) within 6 weeks of receiving a previous dose of an mRNA COVID-19 vaccine. This includes any individual who had an abnormal cardiac investigation including electrocardiogram (ECG), elevated troponins, echocardiogram or cardiac MRI after a dose of mRNA vaccine
      • Those with a history of pericarditis following a dose of mRNA COVID-19 vaccine and who either had no cardiac workup or had normal cardiac investigations can be revaccinated once they are symptom free and at least 90 days has passed since previous COVID-19 vaccine dose.
      • Among those with confirmed myocarditis (with or without pericarditis) following a dose of mRNA COVID-19 vaccine:
        • Administration of subsequent dose(s) of an mRNA COVID-19 vaccine may be considered in certain circumstances upon consultation with the individual’s specialist(s). Considerations for subsequent dose administration may include personal risk of severe acute COVID-19 (e.g., age, underlying conditions) as well as level of COVID-19 community transmission and personal risk of infection.
          • These individuals should be informed of the unknown risk of recurrence of myocarditis and pericarditis following a subsequent mRNA COVID-19 vaccine dose.
          • If vaccination with a dose of mRNA COVID-19 vaccine is chosen, they should wait at least until their episode of myocarditis or pericarditis has completely resolved. This includes resolution of symptoms attributed to myocarditis or pericarditis, as well as no evidence of ongoing heart inflammation or sequelae as determined by the individual's clinical team.
      • Individuals should be advised to seek medical attention if they develop symptoms including chest pain, shortness of breath or palpitations.

    • History of myocarditis or carditis unrelated to mRNA COVID-19 vaccination
      • This is not a contraindication to being immunized with Pfizer BioNTech Comirnaty™.

  • History of multisystem inflammatory syndrome (MIS) in children/adolescents (MIS-C) or adults (MIS-A)
    • MIS-C and MIS-A have very rarely been reported following mRNA COVID-19 vaccination; however, causality has not been established.
    • MIS-C has been reported as a complication of COVID-19 infection; real world evidence among adolescents 12 to 18 years of age suggests vaccination with age-appropriate mRNA vaccine reduces the risk of hospitalization due to MIS-C.
    • COVID-19 vaccination in individuals with a history of MIS-C or MIS-A should be delayed until clinical recovery or until ≥ 90 days since diagnosis, whichever is longer.
  • NOTECertain populations were excluded from the initial vaccine trials including pregnancy, breastfeeding, immunocompromised/immunosuppressed, and those with autoimmune conditions

    • 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 moderately to severely immunocompromised have shown lower immune responses to the COVID-19 vaccines compared to those who are immunocompetent. These individuals will need to continue to take precautions against SARS-CoV-2 infection even if fully vaccinated. The possibility of reduced immune response in those who are immunocompromised exists for most vaccines.
      • Moderna Spikevax™ may offer potentially greater immune response than Pfizer-BioNTech Comirnaty™, though Comirnaty™ is preferred for those under 30 years old.

    • 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

06 Sep 2022

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 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 there are also no recommendations in Saskatchewan against these longer intervals.
    • Based on vaccine and immunology principles, longer intervals between infection and vaccination are expected to produce more robust and durable responses to the vaccine.
    • See table below for suggestions.

NACI Suggested Intervals Between Previous SARS-CoV-2 Infection and Immunization with Pfizer-BioNTech Comirnaty™ 

SARS-CoV-2 Infection timing relative to COVID-19 vaccination

Population

Suggested interval between SARS-CoV-2 infection and vaccination

Infection prior to initiation or completion of primary vaccination series

(Primary series for individuals moderately to severely immunocompromised is 3 doses)

 

 

No previous history of MIS-C or MIS-A following vaccination

Not moderately to severely immunocompromised

Vaccine dose 8 weeks after symptom onset or positive test (if asymptomatic)

No previous history of MIS-C or MIS-A following vaccination

Moderately to severely immunocompromised

Vaccine dose 4-8 weeks after symptom onset or positive test (if asymptomatic)

Previous history of MIS-C or MIS-A following vaccination

Regardless of immunocompromised status

Vaccine dose when recovered clinically or at least 90 days since onset of MIS-C or MIS-A, whichever is longer

Infection after primary series but before booster dose

Individuals 12 years and older currently eligible for a booster dose

3 months after symptom onset or positive test (if asymptomatic) so long as at least 6 months from completing primary series

MIS-A = multisystem inflammatory syndrome in adults; MIS-C = multisystem inflammatory syndrome in children

References

22 Jun 2022

Original product labelling indicated each vial contained 5 doses, though there were reports that some were able to extract 6 full 0.3 ml doses. On February 9, 2021, Health Canada announced the labelling is being updated to reflect 6 doses per vial to minimize wastage and increase access. It is possible to extract 6 full doses using low dead-volume syringes and/or needles. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose

Reference

 26 Apr 2021

The recommendation is to keep the needle in the vial and expel the air. The needle should not be removed from the vial prior to expelling air to avoid potential wastage of the vaccine.

Reference

05 May 2021