Pfizer-BioNTech Covid-19 Vaccine

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Health Canada has authorized use of COVID-19 vaccine in adolescents aged 12 to 15 years under Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

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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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Product Monograph

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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 12 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

Prior to Dilution:

The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial contains a volume of 0.45 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to administration.
Vials may be thawed in the refrigerator (2°C to 8°C [35°F to 46°F])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.
Refer to thawing instructions in the panels below.

Dilution:

Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form the Pfizer-BioNTech COVID-19 Vaccine. Do not add more than 1.8 mL of diluent.
ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent 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, one vial contains 6^† doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Product Monograph regarding the number of doses per vial after dilution supersedes the number of doses stated on the vial labels and cartons.
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.
Refer to dilution and dose preparation instructions in the panels below.

†: Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a 6^th dose from a single vial.

THAWING PRIOR TO DILUTION
	Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by: Allowing vial(s) to thaw in the refrigerator (2°C to 8°C [35°F to 46°F]). A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. Allowing vial(s) to sit at room temperature (up to 25°C [77°F]) for 30 minutes. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature.
	Before dilution, invert vaccine vial gently 10 times. Do not shake. Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. Do not use if liquid is discoloured or if other particles are observed.
DILUTION
	Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent. Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (21-gauge or narrower needle). Cleanse the vaccine vial stopper with a single-use antiseptic swab. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial.
	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. Inspect the vaccine in the vial. The vaccine will be an off-white suspension. Do not use if vaccine is discoloured or contains particulate matter.
	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, preferentially using low dead-volume syringes and/or needles. Each dose must contain 0.3 mL of vaccine. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Administer immediately, and no later than 6 hours after dilution. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction.

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, preferentially using low dead-volume syringes and/or needles.
Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Administer immediately, and no later than 6 hours after dilution.
Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction.

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.
confirm there are no particulates and that no discolouration is observed.
do not administer if vaccine is discoloured or contains particulate matter.

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

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. If standard syringes and needles are used, there may not be sufficient volume to extract a 6^th dose from a single vial. Irrespective of the type of syringe and needle:

Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials.

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Overdosage

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Dosage Forms, Strengths, Composition And Packaging

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Pfizer-BioNTech COVID-19 Vaccine multiple dose vials are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials. Not all pack sizes may be available.

Table 1 – Dosage Forms, Strengths, Composition and Packaging
Route of Administration	Dosage Form / Strength/Composition	Non-medicinal Ingredients
† Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a 6^th dose from a single vial. * Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Product Monograph regarding the number of doses per vial after dilution supersedes the number of doses stated on the vial labels and cartons.
Intramuscular injection	Suspension (to be diluted) Multiple dose vial (after dilution, each vial contains 6^†* 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

Pfizer-BioNTech COVID-19 Vaccine is a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection. Pfizer-BioNTech COVID-19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2 and the non-medicinal ingredients listed in Table 1 above.

Pfizer-BioNTech COVID-19 Vaccine is packaged in a clear glass 2 mL vial with a rubber stopper (not made with natural rubber latex), aluminum overseal, and flip-off cap.

To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date.

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Warnings And Precautions

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Acute Allergic Reactions

Anaphylaxis has been reported. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine.

Vaccine recipients should be kept under observation for at least 15 minutes after immunization; 30 minutes is a preferred interval when there is a specific concern about a possible vaccine reaction.

A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Pfizer-BioNTech COVID-19 Vaccine.

Cardiovascular

Myocarditis and Pericarditis

Very rare cases of myocarditis and/or pericarditis following vaccination with Pfizer-BioNTech COVID-19 Vaccine have been reported during post-authorization use. These cases occurred more commonly after the second dose and in adolescents and young adults. Typically, the onset of symptoms has been within a few days following receipt of the Pfizer-BioNTech COVID-19 Vaccine. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances.

Healthcare professionals are advised to consider the possibility of myocarditis and/or pericarditis in their differential diagnosis if individuals present with chest pain, shortness of breath, palpitations or other signs and symptoms of myocarditis and/or pericarditis following immunization with a COVID-19 vaccine. This could allow for early diagnosis and treatment. Cardiology consultation for management and follow up should be considered.

General

The administration of Pfizer-BioNTech COVID-19 Vaccine should be postponed in individuals suffering from acute severe febrile illness.

As with any vaccine, vaccination with Pfizer-BioNTech COVID-19 Vaccine may not protect all recipients.

Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see CLINICAL TRIALS section).

Hematologic

Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration.

Immune

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.

Special Populations

Pregnant Women

The safety and efficacy of Pfizer-BioNTech COVID-19 Vaccine in pregnant women have not yet been established.

Breast-feeding

It is unknown whether Pfizer-BioNTech COVID-19 Vaccine is excreted in human milk. A risk to the newborns/infants cannot be excluded.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunization against COVID-19.

Pediatrics

The safety and efficacy of Pfizer-BioNTech COVID-19 Vaccine in children under 12 years of age have not yet been established.

Geriatrics

Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (See ADVERSE REACTIONS and CLINICAL TRIALS sections).

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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 12 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) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. Of these, approximately 43,448 participants (21,720 Pfizer BioNTech COVID 19 Vaccine; 21,728 placebo) in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2260 adolescents are 12 to 15 years of age (1131 and 1129 in the vaccine and placebo groups, respectively).

At the time of the analysis of Study 2 (data accrued through November 14, 2020), a total of 37,586 (18,801 Pfizer-BioNTech COVID-19 Vaccine and 18,785 placebo) participants 16 years of age or older had been followed for a median of 2 months after the second dose of Pfizer BioNTech COVID 19 Vaccine. Of these, 19,067 (9,531 Pfizer-BioNTech COVID-19 Vaccine and 9,536 placebo) participants 16 years of age or older had at least 2 months of follow-up after Dose 2.

In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2260 adolescents (1131 Pfizer‑BioNTech COVID‑19 Vaccine; 1129 placebo) were 12 to 15 years of age. Of these, 1308 (660 Pfizer‑BioNTech COVID‑19 Vaccine and 648 placebo) adolescents have been followed for at least 2 months after the second dose of Pfizer-BioNTech COVID-19 Vaccine.

The safety evaluation of participants in Study 2 is still ongoing. Participants 18 years of age and older in the reactogenicity subset and adolescents 12 to 15 years of age were monitored for solicited local and systemic reactions, and use of antipyretic medication after each vaccination with an electronic diary. 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.

Adverse reactions in adolescents 12 to 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

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.

Participants 16 Years of Age and Older

Solicited Adverse Reactions

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 of the 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 n = Number of participants with the specified reaction. c Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site d Severe: >10.0 cm e Severe: prevents daily activity * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention # Eight participants were between 16 and 17 years of age
Local Reaction	Pfizer-BioNTech COVID-19 Vaccine N^a=2291 n^b (%)	Placebo N^a=2298 n^b (%)	Pfizer-BioNTech COVID-19 Vaccine N^a=2098 n^b (%)	Placebo N^a=2103 n^b (%)
Redness
Any^c	104 (4.5)	26 (1.1)	123 (5.9)	14 (0.7)
Severe^d	6 (0.3)	4 (0.2)	10 (0.5)	0 (0.0)
Swelling
Any^c	132 (5.8)	11 (0.5)	132 (6.3)	5 (0.2)
Severe^d	5 (0.2)	3 (0.1)	7 (0.3)	0 (0.0)
Pain at the Injection Site
Any^c	1904 (83.1)	322 (14.0)	1632 (77.8)	245 (11.7)
Severe^e	24 (1.0)	2 (0.1)	25 (1.2)	0 (0.0)
Any local reaction^c	1916 (83.6)	338 (14.7)	1638 (78.1)	256 (12.2)

Table 3: Study 2 – Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose – Participants 18-55 Years of Age^# (Reactogenicity Subset of the Safety Population^*#)
Systemic 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 n = Number of participants with the specified reaction. c Any systemic reaction: 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 d Severe: prevents daily activity e Severe: requires intravenous hydration f Severe: 6 or more loose stools in 24 hours * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention # Eight participants were between 16 and 17 years of age
Systemic Reaction	Pfizer-BioNTech COVID-19 Vaccine N^a=2291 n^b (%)	Placebo N^a=2298 n^b (%)	Pfizer-BioNTech COVID-19 Vaccine N^a=2098 n^b (%)	Placebo N^a=2103 n^b (%)
Fever
≥38.0°C	85 (3.7)	20 (0.9)	331 (15.8)	10 (0.5)
>38.9°C	6 (0.3)	5 (0.2)	27 (1.3)	2 (0.1)
Fatigue
Any	1085 (47.4)	767 (33.4)	1247 (59.4)	479 (22.8)
Severe^d	33 (1.4)	11 (0.5)	97 (4.6)	14 (0.7)
Headache
Any	959 (41.9)	775 (33.7)	1085 (51.7)	506 (24.1)
Severe^d	23 (1.0)	19 (0.8)	67 (3.2)	15 (0.7)
Chills
Any	321 (14.0)	146 (6.4)	737 (35.1)	79 (3.8)
Severe^d	9 (0.4)	2 (0.1)	45 (2.1)	0 (0.0)
Vomiting
Any	28 (1.2)	28 (1.2)	40 (1.9)	25 (1.2)
Severe^e	0 (0.0)	1 (0.0)	4 (0.2)	0 (0.0)
Diarrhea
Any	255 (11.1)	270 (11.7)	219 (10.4)	177 (8.4)
Severe^f	3 (0.1)	1 (0.0)	4 (0.2)	1 (0.0)
New or worsened muscle pain
Any	487 (21.3)	249 (10.8)	783 (37.3)	173 (8.2)
Severe^d	13 (0.6)	2 (0.1)	47 (2.2)	3 (0.1)
New or worsened joint pain
Any	251 (11.0)	138 (6.0)	459 (21.9)	109 (5.2)
Severe^d	5 (0.2)	0 (0.0)	20 (1.0)	4 (0.2)
Any systemic reaction^c	1538 (67.1)	1243 (54.1)	1557 (74.2)	803 (38.2)
Use of antipyretic or pain medication	638 (27.8)	332 (14.4)	945 (45.0)	266 (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 of the 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 n = Number of participants with the specified reaction. c Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site d Severe: >10.0 cm e Severe: prevents daily activity * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
Local Reaction	Pfizer-BioNTech COVID-19 Vaccine N^a=1802 n^b (%)	Placebo N^a=1792 n^b (%)	Pfizer-BioNTech COVID-19 Vaccine N^a=1660 n^b (%)	Placebo N^a=1646 n^b (%)
Redness
Any^c	85 (4.7)	19 (1.1)	120 (7.2)	12 (0.7)
Severe^d	3 (0.2)	2 (0.1)	8 (0.5)	1 (0.1)
Swelling
Any^c	118 (6.5)	21 (1.2)	124 (7.5)	11 (0.7)
Severe^d	2 (0.1)	0 (0.0)	3 (0.2)	1 (0.1)
Pain at the Injection Site
Any^c	1282 (71.1)	166 (9.3)	1098 (66.1)	127 (7.7)
Severe^e	4 (0.2)	0 (0.0)	8 (0.5)	0 (0.0)
Any local reaction^c	1300 (72.1)	187 (10.4)	1110 (66.9)	140 (8.5)

Table 5: Study 2 – Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose – Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*)
Systemic 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 n = Number of participants with the specified reaction. c Any systemic reaction: 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 d Severe: prevents daily activity e Severe: requires intravenous hydration f Severe: 6 or more loose stools in 24 hours * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention
Systemic Reaction	Pfizer-BioNTech COVID-19 Vaccine N^a=1802 n^b (%)	Placebo N^a=1792 n^b (%)	Pfizer-BioNTech COVID-19 Vaccine N^a=1660 n^b (%)	Placebo N^a=1646 n^b (%)
Fever
≥38.0°C	26 (1.4)	7 (0.4)	181 (10.9)	4 (0.2)
>38.9°C	2 (0.1)	2 (0.1)	5 (0.3)	1 (0.1)
Fatigue
Any	615 (34.1)	405 (22.6)	839 (50.5)	277 (16.8)
Severe^d	2 (0.1)	3 (0.2)	46 (2.8)	2 (0.1)
Headache
Any	454 (25.2)	325 (18.1)	647 (39.0)	229 (13.9)
Severe^d	2 (0.1)	3 (0.2)	9 (0.5)	4 (0.2)
Chills
Any	113 (6.3)	57 (3.2)	377 (22.7)	46 (2.8)
Severe^d	0 (0.0)	1 (0.1)	17 (1.0)	0 (0.0)
Vomiting
Any	9 (0.5)	9 (0.5)	11 (0.7)	5 (0.3)
Severe^e	0 (0.0)	0 (0.0)	1 (0.1)	0 (0.0)
Diarrhea
Any	147 (8.2)	118 (6.6)	137 (8.3)	99 (6.0)
Severe^f	3 (0.2)	1 (0.1)	2 (0.1)	4 (0.2)
New or worsened muscle pain
Any	251 (13.9)	149 (8.3)	477 (28.7)	87 (5.3)
Severe^d	1 (0.1)	3 (0.2)	16 (1.0)	1 (0.1)
New or worsened joint pain
Any	155 (8.6)	109 (6.1)	313 (18.9)	61 (3.7)
Severe^d	2 (0.1)	1 (0.1)	7 (0.4)	1 (0.1)
Any systemic reaction^c	883 (49.0)	679 (37.9)	1070 (64.5)	464 (28.2)
Use of antipyretic or pain medication	358 (19.9)	213 (11.9)	625 (37.7)	161 (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.

Adolescents 12 to 15 Years of Age

Solicited Adverse Reactions

Table 6 and Table 7 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 adolescents 12 to 15 years of age included in the safety population who were monitored for reactogenicity with an electronic diary.

Table 6: Study 2 – Frequency of Solicited Local Reactions Within 7 Days After Each Dose – Adolescents 12 to 15 Years of Age – Safety Population*
Local Reaction	Pfizer-BioNTech COVID-19 Vaccine Dose 1 N^a=1127 n^b (%)	Placebo Dose 1 N^a=1127 n^b (%)	Pfizer-BioNTech COVID-19 Vaccine Dose 2 N^a=1097 n^b (%)	Placebo Dose 2 N^a=1078 n^b (%)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b n = Number of participants with the specified reaction. c Severe: >10.0 cm. d Severe: prevents daily activity. e Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Redness
Any (>2 cm)	65 (5.8)	12 (1.1)	55 (5.0)	10 (0.9)
Severe^c	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Swelling
Any (>2 cm)	78 (6.9)	11 (1.0)	54 (4.9)	6 (0.6)
Severe^c	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Pain at the injection site
Any	971 (86.2)	263 (23.3)	866 (78.9)	193 (17.9)
Severe^d	11 (1.0)	0 (0.0)	7 (0.6)	0 (0.0)
Any local reaction^e	976 (86.6)	271 (24.0)	872 (79.5)	198 (18.4)

Table 7: Study 2 – Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose – Adolescents 12 to 15 Years of Age – Safety Population*
Systemic Reaction	Pfizer-BioNTech COVID‑19 Vaccine Dose 1 N^a=1127 n^b (%)	Placebo Dose 1 N^a=1127 n^b (%)	Pfizer-BioNTech COVID‑19 Vaccine Dose 2 N^a=1097 n^b (%)	Placebo Dose 2 N^a=1078 n^b (%)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. a N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. b n = Number of participants with the specified reaction. c Severe: prevents daily activity. d Severe: requires intravenous hydration. e Severe: 6 or more loose stools in 24 hours. f Any systemic reaction: 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 * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Fever
≥38.0°C	114 (10.1)	12 (1.1)	215 (19.6)	7 (0.6)
>38.9°C	11 (1.0)	2 (0.2)	25 (2.3)	1 (0.1)
Fatigue
Any	677 (60.1)	457 (40.6)	726 (66.2)	264 (24.5)
Severe^c	15 (1.3)	8 (0.7)	26 (2.4)	4 (0.4)
Headache
Any	623 (55.3)	396 (35.1)	708 (64.5)	263 (24.4)
Severe^c	11 (1.0)	9 (0.8)	22 (2.0)	1 (0.1)
Chills
Any	311 (27.6)	109 (9.7)	455 (41.5)	73 (6.8)
Severe^c	5 (0.4)	2 (0.2)	20 (1.8)	0 (0.0)
Vomiting
Any	31 (2.8)	10 (0.9)	29 (2.6)	12 (1.1)
Severe^d	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Diarrhea
Any	90 (8.0)	82 (7.3)	65 (5.9)	43 (4.0)
Severe^e	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
New or worsened muscle pain
Any	272 (24.1)	148 (13.1)	355 (32.4)	90 (8.3)
Severe^c	2 (0.2)	0 (0.0)	6 (0.5)	2 (0.2)
New or worsened joint pain
Any	109 (9.7)	77 (6.8)	173 (15.8)	51 (4.7)
Severe^c	1 (0.1)	0 (0.0)	4 (0.4)	0 (0.0)
Any systemic reactions^f	877 (77.8)	636 (56.4)	904 (82.4)	439 (40.7)
Use of antipyretic or pain medication	413 (36.6)	111 (9.8)	557 (50.8)	95 (8.8)

Unsolicited Adverse Events

In the analysis of Study 2 among adolescents 12 to 15 years of age, 98.3% of study participants had at least 30 days of follow-up after Dose 2 (1131 adolescents received Pfizer‑BioNTech COVID-19 Vaccine and 1129 adolescents received placebo).

Unsolicited adverse events (both serious and non-serious) were reported by 6.4% of Pfizer BioNTech COVID-19 Vaccine recipients and by 6.3% of placebo recipients. Serious adverse events were reported by 0.4% of Pfizer BioNTech COVID-19 Vaccine recipients and by 0.2% of placebo recipients.

Post-Market Adverse Reactions

The following adverse reactions have been identified during post authorization use of Pfizer‑BioNTech COVID-19 Vaccine.

Cardiac disorders: myocarditis and/or pericarditis (see WARNING AND PRECAUTIONS section)

Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)

Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. They are included because: a) they represent reactions that are known to occur following immunizations generally; b) they are potentially serious; or c) on the basis of their frequency of reporting.

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During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Do not refreeze thawed vials.

Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials 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 COVID19 Vaccine Storage and Handling Reference Guide provided (also available at CVDvaccine.ca). Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -80°C to -60°C (-112°F to -76°F) until the expiry date printed on the label. Vials may also be stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -80°C to - 60°C (-112°F to -76°F). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks.

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 of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an excursion from the recommended storage condition.

Transportation of Frozen Vials
If local redistribution is needed and full cartons containing vials cannot be transported at -90°C to -60°C (-130°F to -76°F), vials may be transported at -25°C to -15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to 5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F). Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one time to the recommended storage condition of -80°C to - 60°C (-112°F to -76°F).

Thawed Vials Prior to Dilution

Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2°C to 8°C [35°F to 46°F]) for up to 1 month. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time.

Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25°C (77°F)] for 30 minutes.

Thawed vials can be handled in room light conditions.

Vials must reach room temperature before dilution.

Undiluted vials may be stored at room temperature for no more than 2 hours.

Transportation of Thawed Vials
Available data support transportation of one or more thawed vials at 2°C to 8°C (35°F to 46°F) for up to 12 hours. Any hours used for transport at 2°C to 8°C (35°F to 46°F) count against the 1-month limit for storage at 2°C to 8°C (35°F to 46°F).

Vials After Dilution
After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. Any vaccine remaining in vials must be discarded after 6 hours. After dilution, the vaccine vials can be handled in room light conditions. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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:

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