Product Information

  • Individuals 16 years of age and older.
  • 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.
        • If the 2nd dose is delayed beyond 28 days, 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.
    • Summary: Ideally, the 2nd dose is given between 21 and 28 days after the 1st dose.
      • It must be given at least 19 days after the 1st dose, otherwise the 2nd dose will need to be repeated.
      • If the 2nd dose is given later than 28 days, there is no need to restart the series but full protection requires both doses.
    • NOTE: As of March 3, 2021, NACI recommends that in the context of limited COVID-19 vaccine supply, jurisdictions should maximize the number of individuals benefiting from the first dose of vaccine by extending the interval for the second dose of vaccine to 4 months. This recommendation is subject to revision as evidence evolves.
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. 

Drug Interactions

There are no known drug interactions. However, if the patient is immunosuppressed by medication or disease state, they should not receive the vaccine at this time. Immunosuppressive medications include high dose steroids and certain biologics; more examples can be found here. 

  • Under 16 years of age
    • The Pfizer-BioNTech vaccine is approved for use in persons 16 years of age and older
    • Only limited clinical data in persons 12 to 15 years of age are available. If the client is at risk of severe outcomes of COVID-19 because of underlying medical condition AND is at increased risk of exposure, vaccination may be considered.
  • Certain populations (see below) have been excluded from the initial vaccine trials. At this time, NACI recommends that a risk-benefit analysis be conducted for these populations, including that the vaccine recipient/caregiver understands the absence of evidence of the safety and effectiveness in these populations at this time. If benefit outweighs risk (e.g. someone in one of these populations who cannot avoid potential exposure to the virus) and the person is in the authorized age group, the vaccine should be offered. At this time, there are no known harms in these populations. See the NACI Statement for more information regarding these populations and risk assessment. These populations include those who are/have:
    • Immunosuppressed from disease or treatment
    • Autoimmune conditions
      • See the Canadian Immunization Guideline Part 3 – Vaccination of Specific Populations for additional general information on autoimmune disorders and chronic inflammatory diseases. 
    • Currently pregnant or planning pregnancy before receiving both doses
      • NACI recommends delaying pregnancy until at least 28 days after the last dose to be prudent. However, receipt of vaccine before this time period is not a reason to terminate pregnancy.
      • The Society of Obstetricians and Gynaecologists of Canada (SOGC)- Statement on COVID-19 Vaccination in Pregnancy 
    • Currently breastfeeding
Other reasons to avoid the vaccine:
  • 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.
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.
    • However, the recommendation is for clients to wait 3 months to take advantage of the client's natural immunity and to leave the current supply of vaccine for others without immunity.
    • Trial included <10% participants with COVID-19 infection proven by serology.

No. At this time, NACI is recommending: 

  • The COVID-19 vaccines should be administered at least 14 days AFTER any other vaccines (live or inactivated).
  • Other vaccines should be avoided for 28 days AFTER receiving the last COVID-19 vaccine dose. 
  • Exception: If a patient requires a vaccination as part of a post-exposure prophylaxis protocol, it should be administered.

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. Excess vaccine from multiple vials should not be pooled to create extra doses.

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.