Full Prescribing Information & EUA Fact Sheets
FDA EUA Letter Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers (12 Years & Up) –Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve.
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Full Prescribing Information & EUA Fact Sheets
FDA EUA Letter Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers (12 Years & Up) –
In individuals 16 years of age and older, COMIRNATY® (
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (
*When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (
Three vaccine presentations are now available with different preparation and storage guidelines.
See immediately below for information on Gray Cap and Orange Cap vials.
For dosing, preparation, and storage guidelines for Ages 12 years and older
View the EUA Fact Sheet for Vaccination Providers
Click here for expiry information.
For dosing, preparation, and storage guidelines for Ages 5 through 11 years
View the EUA Fact Sheet for Vaccination Providers
Click here for expiry information.
Unless otherwise specified, the remainder of the website applies only to the Ages 12 & Up DILUTE BEFORE USE Purple Cap Presentation.
In individuals 16 years of age and older1
Please see the full Prescribing Information to see the clinical trial design and efficacy (Section 14 - pg. 17) and safety (Section 6 - pg. 8).1
In individuals 12 through 15 years of age2
Please see the EUA Fact Sheet for Vaccination Providers to see the clinical trial design and efficacy (Section 18 - pg. 45) and safety (Section 6 - pg. 27).2
Important Safety Information
Indication & Authorized Use
Important Safety Information
Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
The vaccine may not protect all vaccine recipients.
Primary Series Adverse Events:
In clinical studies (30 mcg modRNA) of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site
swelling (10.6%).
In clinical studies (30 mcg modRNA) of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
In a clinical study (30 mcg modRNA) of adolescents 12 through 15 years of age, adverse reactions following the administration of the primary series 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%).
In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).
Booster Dose Adverse Events:
In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).
Before administration of the vaccine, please click to see
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, Purple Cap
Full Prescribing Information (16 years of age and older) DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE
BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT
DILUTE, Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE
BEFORE USE, Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
Indication & Authorized Use
The FDA-approved COMIRNATY® (
COMIRNATY® (
Indication
COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (
Authorized Use
The
COMIRNATY® (
For more information
Pfizer Customer Service
Call
1-800-879-3477.
Medical Information
Visit
PfizerMedicalInformation.com
or call
1-800-438-1985.
General Product Inquiries
Call
1-877-829-2619.
Shipment Support
US Trade Customer Service
Call
1-800-666-7248.
Label Update: Effective 01/03/22
The Emergency Use Authorization (EUA) Fact Sheets for Vaccination Providers for individuals 12 years of age and older have been updated. Changes include (but are not limited to) the following sections:
New Language in Teal
2.3 Vaccination Schedule
Booster Dose
A single Pfizer‑BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older.
Click below to view:
The Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers for individuals 5 through 11 years of age has been updated. Changes include (but are not limited to) the following sections:
New Language in Teal
2.3 Vaccination Schedule
A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) at least 28 days following the second dose is authorized for administration to individuals 5 through 11 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Click below to view:
Selected Safety Information
Booster Dose Adverse Events - In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).
Three vaccine presentations are available with different preparation and storage guidelines.
As of 12/16/21, Ages 12 years and older, DO NOT DILUTE (Gray Cap) and 5 through 11 years, DILUTE BEFORE USE (Orange Cap) have extended expiry from 6 months to 9 months from the date of manufacture printed on the vial and cartons in an Ultra-Low-Temperature (ULT) Freezer -90°C to -60°C (-130°F to -76°F).
Please see the table below and click the following button for expiry information:
Children ages 5 through 11 years old should only be vaccinated with the Ages 5 through 11 years (“Age 5y to <12y” on vial label) Dilute Before Use Orange Cap presentation. No other vaccine presentation should be used for children 5 through 11 years old because of the potential for vaccine administration errors, including dosing errors. For children who will turn 12 between their first and second dose, consult the EUA Fact Sheets for Vaccination Providers.
For questions, contact US Medical Information at 1-800-438-1985 or visit PfizerMedicalInformation.com.
| Description | Dilute Before Use | Do Not Dilute | Dilute Before Use |
|---|---|---|---|
| Age Group | 12 years and older | 12 years and older | 5 through 11 years ("Age 5y to <12y" on vial label) |
| Vial Cap Color | PURPLE |
GRAY |
ORANGE |
| Dose | 30 mcg | 30 mcg | 10 mcg |
| Dose Volume | 0.3 mL | 0.3 mL | 0.2 mL |
| Amount of Diluent Needed per Vial* | 1.8 mL | NO DILUTION | 1.3 mL |
| Doses per Vial | 6 doses per vial (after dilution) |
6 doses per vial | 10 doses per vial (after dilution) |
| Emergency Use Authorization (EUA) Fact Sheet | Click here | Click here | Click here |
| Storage Conditions | |||
| Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C (-130°F to -76°F)] |
9 months† | 9 months‡ | 9 months‡ |
| Freezer [-25°C to -15°C (-13°F to 5°F)] |
2 weeks | DO NOT STORE | DO NOT STORE |
| Refrigerator [2°C to 8°C (35°F to 46°F)] |
1 month | 10 weeks | 10 weeks |
| Room Temperature [8°C to 25°C (46°F to 77°F)] |
2 hours prior to dilution (including any thaw time) |
12 hours prior to first puncture (including any thaw time) |
12 hours prior to dilution (including any thaw time) |
| After First Puncture [2°C to 25°C (35°F to 77°F)] |
Discard after 6 hours | Discard after 12 hours | Discard after 12 hours |
| Description | Dilute Before Use | ||
|---|---|---|---|
| Age Group | 12 years and older | ||
| Vial Cap Color | PURPLE |
||
| Dose | 30 mcg | ||
| Dose Volume | 0.3 mL | ||
| Amount of Diluent Needed per Vial* | 1.8 mL | ||
| Doses per Vial | 6 doses per vial (after dilution) |
||
| Emergency Use Authorization (EUA) Fact Sheet | Click here | ||
| Storage Conditions | |||
| Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C (-130°F to -76°F)] |
9 months† | ||
| Freezer [-25°C to -15°C (-13°F to 5°F)] |
2 weeks | ||
| Refrigerator [2°C to 8°C (35°F to 46°F)] |
1 month | ||
| Room Temperature [8°C to 25°C (46°F to 77°F)] |
2 hours prior to dilution (including any thaw time) |
||
| After First Puncture [2°C to 25°C (35°F to 77°F)] |
Discard after 6 hours | ||
| Description | Do Not Dilute | ||
|---|---|---|---|
| Age Group | 12 years and older | ||
| Vial Cap Color | GRAY |
||
| Dose | 30 mcg | ||
| Dose Volume | 0.3 mL | ||
| Amount of Diluent Needed per Vial* | NO DILUTION | ||
| Doses per Vial | 6 doses per vial | ||
| Emergency Use Authorization (EUA) Fact Sheet | Click here | ||
| Storage Conditions | |||
| Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C (-130°F to -76°F)] |
9 months† | ||
| Freezer [-25°C to -15°C (-13°F to 5°F)] |
DO NOT STORE | ||
| Refrigerator [2°C to 8°C (35°F to 46°F)] |
10 weeks | ||
| Room Temperature [8°C to 25°C (46°F to 77°F)] |
12 hours prior to first puncture (including any thaw time) |
||
| After First Puncture [2°C to 25°C (35°F to 77°F)] |
Discard after 12 hours | ||
| Description | Dilute Before Use | ||
|---|---|---|---|
| Age Group | 5 through 11 years ("Age 5y to <12y" on vial label) |
||
| Vial Cap Color | ORANGE |
||
| Dose | 10 mcg | ||
| Dose Volume | 0.2 mL | ||
| Amount of Diluent Needed per Vial* | 1.3 mL | ||
| Doses per Vial | 10 doses per vial (after dilution) |
||
| Emergency Use Authorization (EUA) Fact Sheet | Click here | ||
| Storage Conditions | |||
| Ultra-Low-Temperature (ULT) Freezer [-90°C to -60°C (-130°F to -76°F)] |
9 months† | ||
| Freezer [-25°C to -15°C (-13°F to 5°F)] |
DO NOT STORE | ||
| Refrigerator [2°C to 8°C (35°F to 46°F)] |
10 weeks | ||
| Room Temperature [8°C to 25°C (46°F to 77°F)] |
12 hours prior to dilution (including any thaw time) |
||
| After First Puncture [2°C to 25°C (35°F to 77°F)] |
Discard after 12 hours | ||
*Diluent: sterile 0.9% Sodium Chloride Injection, USP. Bacteriostatic saline or other diluents must NOT be used.
†Regardless of storage condition, vaccine should not be used past the 9-month expiry (6 months printed on the vial plus additional 3 months).
‡Regardless of storage condition, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons.
Emergency Use Authorization
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
I acknowledge that this website is being updated on an ongoing basis. Unless otherwise specified, the remainder of the website applies only to the Ages 12 & Up DILUTE BEFORE USE Purple Cap Presentation. I will check back for further updates.
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