Pfizer-BioNTech Covid-19 Vaccine

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HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 Vaccine UNDER AN INTERIM ORDER
PFIZER-BIONTECH COVID-19 VACCINE is indicated for:

Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

The use of PFIZER-BIONTECH COVID-19 VACCINE is permitted under an interim authorization delivered in accordance with section 5 of the COVID-19 Interim order (IO)*. Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. *https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs.html#a2.8

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

Pfizer-BioNTech COVID-19 Vaccine Quick Finder

Report an adverse event or concern about the quality of a Pfizer product

To report and adverse reaction, or concern about the quality of a Pfizer product, please call Pfizer 1 866 723-7111 or visit www.healthcanada.gc.ca/medeffect or call Canada Vigilance Program at 1-866-234-2345.
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
Pfizer-BioNTech COVID-19 Vaccine site
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Note: the information below includes the Part I: Health Professional Information.

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Health Professional Information

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Contraindications

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Serious Warnings And Precautions

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Dosage And Administration

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Dosing Considerations

Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection which must be diluted prior to administration. After preparation, a single dose is 0.3 mL.

Recommended Dose and Dosage Adjustment

Vaccination Schedule for Individuals 16 Years of Age and Older
Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly after dilution as a series of two doses (0.3 mL each) 21 days apart (see Trial Design and Study Demographics section).

There are no data available on the interchangeability of Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.

Reconstitution

Preparation for Administration

The Pfizer‑BioNTech COVID-19 Vaccine multiple dose vial contains a frozen suspension that does not contain preservative and must be thawed and diluted prior to administration.
Vials may be thawed in the refrigerator (2°C to 8°C)or at room temperature (up to 25°C [77°F]) (see STORAGE, STABILITY AND DISPOSAL section).
Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles.
The contents of the vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form the Pfizer‑BioNTech COVID-19 Vaccine.
0.9% Sodium Chloride Injection, USP is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.
After dilution, the vial contains 5 doses of 0.3 mL.
After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed.
Strict adherence to aseptic techniques must be followed.

DILUTE BEFORE USE
	Remove a thawed vial of Pfizer-BioNTech COVID‑19 Vaccine from the refrigerator and allow it to come to room temperature. If using a frozen vial of Pfizer‑BioNTech COVID‑19 Vaccine, thaw for 30 minutes at room temperature. Vials at room temperature must be diluted within 2 hours.
	Before dilution, invert gently 10 times to mix. Do not shake.
	Obtain sterile 0.9% Sodium Chloride Injection, USP. Cleanse the vial stopper with a single-use antiseptic swab. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the Pfizer‑BioNTech COVID-19 Vaccine vial using a needle 21‑gauge or narrower.
	Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
	Gently invert the vial containing the Pfizer‑BioNTech COVID-19 Vaccine 10 times to mix. Do not shake.
	Record the date and time of dilution on the Pfizer‑BioNTech COVID-19 Vaccine vial label. Store between 2°C to 25°C (35°F to 77°F). Discard any unused vaccine 6 hours after dilution.

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER‑BIONTECH COVID-19 VACCINE
	Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine. Administer immediately, and no later than 6 hours after dilution.

Administration

Visually inspect each dose in the dosing syringe prior to administration. The diluted vaccine will be an off‑white suspension. During the visual inspection:

verify the final dosing volume of 0.3 mL, and
confirm there are no particulates and that no discolouration is observed.

If the visual inspection fails, do not administer the vaccine.

Administer Pfizer‑BioNTech COVID-19 Vaccine intramuscularly in the deltoid muscle.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

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Overdosage

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Dosage Forms, Strengths, Composition And Packaging

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Table 1 – Dosage Forms, Strengths, Composition and Packaging
Route of Administration	Dosage Form / Strength/Composition	Non-medicinal Ingredients
Intramuscular injection	Suspension (to be diluted) Multiple dose vial (after dilution, each vial contains 5 doses of 0.3 mL)	ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-distearoyl-sn-glycero-3-phosphocholine cholesterol dibasic sodium phosphate dihydrate monobasic potassium phosphate potassium chloride sodium chloride sucrose water for injection

Warnings And Precautions

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Adverse Reactions

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Adverse Reaction Overview

The safety of Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162‑01 (Study 1) enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) enrolled approximately 44,000 participants, 12 years of age or older.

In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of Pfizer-BioNTech COVID-19 Vaccine and a total of 21,728 participants 16 years of age or older received placebo.

At the time of the analysis of Study 2, a total of 19,067 (9,531 Pfizer-BioNTech COVID-19 Vaccine and 9,536 placebo) participants 16 years of age or older were evaluated for safety 2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine.

The safety evaluation of participants in Study 2 is still ongoing. Participants were monitored for solicited local and systemic events, and use of antipyretic medication after each vaccination. Participants continue to be monitored for unsolicited adverse events, including serious adverse events up to six months after the last vaccine dose (see CLINICAL TRIALS section).

The most frequent adverse reactions in a subset (n=8183) of participants 18 years of age and older, who received the vaccine and comprised a subset of the safety population monitored for reactogenicity with an electronic diary were:, injection site pain ( 84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%),joint pain (23.6%) and fever (14.2%) and were usually mild or moderate in intensity and resolved within a few days after vaccination.

Clinical Trial Adverse Reactions

Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

Tables 2 through 5 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo in the subset of participants 18 years of age and older (n=8183) in the safety population who were monitored for reactogenicity with an electronic diary.

Table 2: Study 2 – Frequency of Solicited Local Reactions Within 7 Days After Each Dose – Participants 18-55 Years of Age (Reactogenicity subset Safety Population^*#)
Local Reaction	Dose 1		Dose 2
a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site c Severe: >10.0 cm d Severe: prevents daily activity * Randomized participants who received at least 1 dose of the study intervention # Five participants were between 16 and 17 years of age
Local Reaction	Pfizer-BioNTech COVID-19 Vaccine N^a=2291 %	Placebo N^a=2298 %	Pfizer-BioNTech COVID-19 Vaccine N^a=2098 %	Placebo N^a=2103 %
Redness
Any^b	4.5	1.1	5.9	0.7
Severe^c	0.3	0.2	0.5	0
Swelling
Any^b	5.8	0.5	6.3	0.2
Severe^c	0.2	0.1	0.3	0
Pain at the Injection Site
Any^b	83.1	14.0	77.8	11.7
Severe^d	1.0	0.1	1.2	0
Any local reaction^b	83.6	14.7	78.1	12.2

Table 3: Study 2 – Frequency of Solicited Systemic Events Within 7 Days After Each Dose – Participants 18-55 Years of Age (Reactogenicity subset Safety Population^*#)
Systemic Event	Dose 1		Dose 2
a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b Any systemic event: any fever ≥38.0°C, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or worsened joint pain c Severe: prevents daily activity d Severe: requires intravenous hydration * All randomized participants who received at least 1 dose of the study intervention # Five participants were between 16 and 17 years of age
Systemic Event	Pfizer-BioNTech COVID-19 Vaccine N^a=2291 %	Placebo N^a=2298 %	Pfizer-BioNTech COVID-19 Vaccine N^a=2098 %	Placebo N^a=2103 %
Fever
≥38.0°C	3.7	0.9	15.8	0.5
>38.9°C	0.3	0.2	1.2	0.1
Fatigue
Any	47.4	33.4	59.4	22.8
Severe^c	1.4	0.5	4.6	0.7
Headache
Any	41.9	33.7	51.7	24.1
Severe^c	1.0	0.8	3.2	0.7
Chills
Any	14.0	6.4	35.1	3.8
Severe^c	0.4	0.1	2.1	0
Vomiting
Any	1.2	1.2	1.9	1.2
Severe^d	0	0	0.2	0
Diarrhea
Any	11.1	11.7	10.4	8.4
Severe^d	0.1	0.0	0.2	0.0
New or worsened muscle pain
Any	21.3	10.8	37.3	8.2
Severe^c	0.6	0.1	2.2	0.1
New or worsened joint pain
Any	11.0	6.0	21.9	5.2
Severe^c	0.2	0	1.0	0.2
Any systemic event^b	67.1	54.1	74.2	38.2
Use of antipyretic or pain medication	27.8	14.4	45.0	12.6

Table 4: Study 2 – Frequency of Solicited Local Reactions Within 7 Days After Each Dose – Participants 56 Years of Age and Older (Reactogenicity subset Safety Population^*)
Local Reaction	Dose 1		Dose 2
a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site c Severe: >10.0 cm d Severe: prevents daily activity * Randomized participants who received at least 1 dose of the study intervention
Local Reaction	Pfizer-BioNTech COVID-19 Vaccine N^a=1802 %	Placebo N^a=1792 %	Pfizer-BioNTech COVID-19 Vaccine N^a=1660 %	Placebo N^a=1646 %
Redness
Any^b	4.7	1.1	7.2	0.7
Severe^c	0.2	0.1	0.5	0.1
Swelling
Any^b	6.5	1.2	7.5	0.7
Severe^c	0.1	0	0.2	0.1
Pain at the Injection Site
Any^b	71.1	9.3	66.1	7.7
Severe^d	0.2	0	0.5	0
Any local reaction^b	72.1	10.4	66.9	8.5

Table 5: Study 2 – Frequency of Solicited Systemic Events Within 7 Days After Each Dose – Participants 56 Years of Age and Older (Reactogenicity subset Safety Population^*)
Systemic Event	Dose 1		Dose 2
a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b Any systemic event: any fever ≥38.0°C, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or worsened joint pain c Severe: prevents daily activity d Severe: requires intravenous hydration * All randomized participants who received at least 1 dose of the study intervention
Systemic Event	Pfizer-BioNTech COVID-19 Vaccine N^a=1802 %	Placebo N^a=1792 %	Pfizer-BioNTech COVID-19 Vaccine N^a=1660 %	Placebo N^a=1646 %
Fever
≥38.0°C	1.4	0.4	10.9	0.2
>38.9°C	0.1	0.1	0.3	0.1
Fatigue
Any	34.1	22.6	50.5	16.8
Severe^c	0.1	0.2	2.8	0.1
Headache
Any	25.2	18.1	39.0	13.9
Severe^c	0.1	0.2	0.5	0.2
Chills
Any	6.3	3.2	22.7	2.8
Severe^c	0	0.1	1.0	0
Vomiting
Any	0.5	0.5	0.7	0.3
Severe^d	0	0	0.1	0
Diarrhea
Any	8.2	6.6	8.3	6.0
Severe^d	0.2	0.1	0.1	0.2
New or worsened muscle pain
Any	13.9	8.3	28.7	5.3
Severe^c	0.1	0.2	1.0	0.1
New or worsened joint pain
Any	8.6	6.1	18.9	3.7
Severe^c	0.1	0.1	0.4	0.1
Any systemic event^b	49.0	37.9	64.5	28.2
Use of antipyretic or pain medication	19.9	11.9	37.7	9.8

Unsolicited Adverse Events

No deaths related to the vaccine were reported in the study.

Serious Adverse Events
In Study 2, in participants 16 to 55 years of age (Pfizer-BioNTech COVID-19 Vaccine = 10,841,  placebo = 10,851), serious adverse events from Dose 1 through 30 days after Dose 2 were reported by 0.4% of participants and by 0.3% of participants who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. In Study 2, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7960, placebo = 7934), serious adverse events were reported by 0.8% of participants and by 0.6% of participants who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively.

Non-Serious Adverse Events
Overall in Study 2, in which 10,841 participants 16 to 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through 30 days after Dose 2 were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. Overall in Study 2, in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. It was reported in the study that lymphadenopathy had occurred. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer‑BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer‑BioNTech COVID-19 Vaccine.

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Drug Interactions

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Clinical Pharmacology

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Storage, Stability And Disposal

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Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials (after dilution each vial contains 5 doses of 0.3 mL) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the Pfizer-BioNTech COVID 19 Vaccine Storage and Handling Reference Guide provided (also available at CVDvaccine.ca). Once received, remove the vial cartons immediately from the thermal container and store in the freezer between -80°C to -60°C (-112°F to -76°F). Vials must be kept frozen between -80°C to -60°C ( -112°F to -76°F) and protected from light, in the original cartons, until ready to use.

If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer- BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90°C to -60°C ( -130°F to -76°F). Storage within this temperature range is not considered an excursion from the recommended storage condition.

Thawed Vials Prior to Dilution
Prior to dilution, multiple dose vials of Pfizer-BioNTech COVID-19 Vaccine may be thawed and stored in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of 25 vials or 195 vials may take up to 2 or 3 hours to thaw in the refrigerator, respectively, whereas a fewer number of vials will thaw in less time. Vials may be stored in the refrigerator for up to 5 days (120 hours). Frozen vials may also be thawed at room temperature [up to 25°C (77°F)]. Prior to dilution, the multiple dose vial may be stored at room temperature for no more than 2 hours. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Thawed vials can be handled in room light conditions. Do not refreeze thawed vials (see DOSAGE AND ADMINISTRATION section).

Vials After Dilution
After dilution, multiple dose vials of Pfizer-BioNTech COVID-19 Vaccine must be stored between 2°C to 25°C (35°F to 77°F) and used within 6 hours from the time of dilution. Any vaccine remaining in vials must be discarded after 6 hours. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. After dilution, the vaccine vials can be handled in room light conditions. Do not freeze. If the vaccine is frozen, it must be discarded.

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To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111.

Canada Vigilance Program

You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect.

Pfizer-BioNTech COVID-19 Vaccine Quick Finder

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Contraindications

Serious Warnings And Precautions