Resources
5 through 11 years of age,
DILUTE BEFORE USE
(Orange Cap)
FDA AUTHORIZED FOR EMERGENCY USE1-4
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 6 months 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.
Resources to support you and your staff
EUA Fact Sheets
Updates to non-English Fact Sheets may be delayed.
Hoja informativa de la EUA para proveedores de vacunación(de 5 a 11 años de edad),
DILUIR ANTES DE USAR, tapa anaranjada
Recipients and Caregivers
(5 Through 11 Years)
Updates to non-English Fact Sheets may be delayed.
Hoja informativa de laEUA para receptores y cuidadores
(de 5 a 11 años de edad)
Storage, Shipping, and Handling Resources
Formulation/PresentationGuide
Updated 06/17/2022 Expiry Information
Updated 07/08/2022 Digital Resource
Sheet
Updated 07/08/2022 Shipping and Handling Guidelines -
Single-Use Thermal Shipping Container
Updated 01/24/2022 Shipping and Handling Guidelines -
Medium Thermal Shipping Container
Updated 04/20/2022 Checklist for Storage, Handling,
and Preparation
Updated 07/08/2022 Return Instructions for Medium and
Single-Use Thermal
Shipping Containers
Updated 10/26/2021
Additional Resources
Preparation and DosingGuide
Updated 07/08/2022 Low Dead-Volume (LDV) Syringe Resource Sheet
Updated 07/08/2022 Select Information Related to Dosing Intervals for the Pfizer-BioNTech COVID-19 Vaccine
Updated 06/15/2022
Helpful links
*By clicking the above link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.
Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine and Registered Trademark Name COMIRNATY®
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Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccine, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate vaccines to protect patients from products that might be dangerous and lead to serious and life-threatening harm
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The vaccine is only administered intramuscularly by a healthcare professional1
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The vaccine is not taken orally and is not available in a capsule or tablet form1
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Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and are dispensed in a vial as follows:
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For 6 months through 4 years of age, DILUTE BEFORE USE, Maroon Cap vials, the vial label includes a maroon border446
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For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border15
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For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border34
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For 12 years of age and older, DILUTE BEFORE USE, Purple Cap vials. Two versions of the vial label are in current circulation - with or without a purple border23
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Ensure the safety of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use.
To prevent counterfeits, discard vaccine vials in sharps containers and empty vial cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through government-authorized vaccination centers – such as doctor’s offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccine can only be administered by licensed healthcare professionals, or other individuals that are approved vaccinators, at government-authorized vaccination sites. Individual doses are not for sale5,68,128,128,99,13
If you suspect the vaccine you have purchased may be counterfeit, contact us at
To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.
- Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap.
Pfizer and BioNTech; June 17, 2022. - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap.
Pfizer and BioNTech; July 8, 2022. - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap.
Pfizer and BioNTech; July 8, 2022. - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap.
Pfizer and BioNTech; June 17, 2022 - COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
- McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.
Indication & Authorized Use
Indication & Authorized Use
Important Safety Information
Important Safety Information
Indication & Authorized Use
COMIRNATY® (
Pfizer-BioNTech COVID-19 Vaccine
Authorized Use
Pfizer-BioNTech
Interchangeability (Primary Series for Individuals 12 Years of Age and Older)
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech
Because of the potential for vaccine administration errors, including dosing errors, vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
Authorized Use
Pfizer-BioNTech
Important Safety Information
Do not administer
Management of Acute Allergic Reactions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of
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/
Myocarditis and Pericarditis
Myocarditis and pericarditis have been reported following administration of the
Postmarketing safety data with
Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the
Syncope
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.
Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to
Limitation of Effectiveness
Adverse Reactions
Primary Series Adverse Events:
Pfizer-BioNTech COVID-19 Vaccine
In a clinical study (3 mcg modRNA) in participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).
In a clinical study (3 mcg modRNA) in participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).
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%).
Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY
In clinical studies (30 mcg modRNA) of adolescents 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) were 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%), and injection site redness (8.6%).
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%).
Booster Dose Adverse Events:
Pfizer-BioNTech COVID-19 Vaccine
In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).
Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY
In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first 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%).
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
The safety of a booster dose of
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safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1),
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safety data from clinical trials which evaluated primary and booster vaccination with
Pfizer-BioNTech COVID-19 Vaccine, and -
post marketing safety data with
Pfizer-BioNTech COVID-19 Vaccine.
The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with
The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants 55 years of age and older. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).
In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of
Post Authorization Experience
Before administration of
Full Prescribing Information (Primary Series 12 years of age and older),
EUA Fact Sheet for Vaccination Providers (Primary Series 12 years of age and older),
EUA Fact Sheet for Vaccination Providers (Primary Series 12 years of age and older),
Recipients and Caregivers Fact Sheet: (Primary Series and Bivalent Booster Dose 12 years of age and older)
For More Information
Now Authorized: Effective 08/31/22
PFIZER-BIONTECH
Click to view the newly authorized EUA Fact Sheet for Vaccination Providers, Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose 12 years of age and older), DO NOT DILUTE, Gray Cap
Emergency Use Authorization
Emergency uses of Pfizer-BioNTech
Authorized Use
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is authorized for use under
an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019
This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Vaccination Schedule
A single booster dose (0.3 mL) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine.
*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the
spike protein of only the Original
Selected Safety Information
Do not administer
Management of Acute Allergic Reactions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of
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).
Myocarditis and Pericarditis
Myocarditis and pericarditis have been reported following administration of
Postmarketing safety data with
Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the
Verify the vials (including labels) prior to preparation and administration to help avoid dosing errors. Check gray cap vial label to ensure that the name on the vial states “
Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vials and cartons.
I acknowledge that this website is being updated on an ongoing basis. I have read the Important Safety Information. I will check back for further updates.
