Product Information

Indication
  • Individuals 12 years of age and older.
Dose
  • 2 x 0.3 ml doses given IM (deltoid)
  • The 2nd dose should be given 21 days after the 1st.
    • The manufacturer recommends a 21-day interval; however:
      • NACI recommends a minimum interval of 19 days between doses (any doses provided at an earlier interval would be considered invalid and need to be repeated).
      • NACI advises that a 28-day interval is acceptable and that intervals up to 16 weeks may be required in the context of vaccine supply constraints.
        • If the 2nd dose is delayed beyond 16 weeks, there is no reason to restart the series. Provide the 2nd dose as soon as possible as both doses are needed for full immune protection.
Adverse Effects 
  • Only short to medium 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 injection site
    • fatigue
    • headache
    • muscle pain
    • chills
    • joint pain
    • fever
  • 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 mRNA vaccination.
      • 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 and Moderna COVID-19 vaccine labels.
Drug Interactions
  • There are no known drug interactions.
  • Under 12 years of age
    • The Pfizer-BioNTech vaccine is approved for use in persons 12 years of age and older.
  • History of anaphylaxis following previous doses of the vaccine.

  • Reported hypersensitivity to one of the ingredients. See product monograph for ingredients.
  • 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.

  • NOTECertain 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 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.
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.
    • Trial included <10% participants with COVID-19 infection proven by serology.
  • Because of no data, to be prudent, simultaneous administration with other vaccines should be avoided to maximize benefits of COVID-19 vaccination while minimizing any risks of harm. Recommended intervals: 

    • ≥14 days after receiving another vaccine before receiving COVID-19 vaccines
      • The main reason for this recommendation is to avoid erroneously attributing AEFIs to a particular vaccine.
    • ≥ 28 days after receiving COVID-19 vaccine before receiving other vaccines
      • The main reason for this recommendation is the theoretical potential for interference of the immune response.
      • If an individual requires a vaccination as part of a post-exposure prophylaxis protocol, it should be administered regardless of timing of any COVID-19 vaccine doses.

  • There may be exceptions in consultation with a primary care provider.

  • If another vaccine(s) is administered within these time intervals (purposely or inadvertently), consider all vaccine doses valid.

References:


 

Saskatchewan is adopting the following strategy for vaccine to use as 2nd dose (following current 2nd dose eligibility).

  • mRNA vaccines (Pfizer-BioNTech or Moderna) are considered interchangeable. Anyone who received an mRNA vaccine for the 1st dose should take whichever of these two vaccines is available to them for their 2nd dose, rather than waiting for the same brand of vaccine. This will provide residents with more options to be immunized sooner.
  • Currently there are limited data regarding safety and efficacy of interchangeability of COVID-19 vaccines. For a review of the current available evidence and to support informed decision making, refer to NACI’s full Statement of Recommendations on the use of COVID-19 Vaccines, Jun 17,2021 or the Summary of Changes, June 17, 2021

    Minimum Intervals Between COVID-19 Vaccine Doses
    Vaccine Brand 1st Dose Vaccine Brand 2nd Dose Interval
    Pfizer-BioNTech Pfizer-BioNTech Minimum 28 days*
    Pfizer-BioNTech Moderna Minimum 28 days
    *21 days is the minimum interval authorized by Health Canada;19 days is included in NACI recommendations based on the per-protocol design for the Pfizer-BioNTech clinical trial that was 19-23 days. The province is adopting a 28 day interval for all vaccines. 
References

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

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.