Resources
5 through 11 years of age,
DILUTE BEFORE USE
(Orange Cap)
Emergency uses of the vaccines 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 aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech
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 12/08/2022 Expiry Information 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 Return Instructions for Medium and
Single-Use Thermal
Shipping Containers
Updated 10/26/2021 Checklist for Storage, Handling, and Preparation
Updated 07/20/2022
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 BioNTech and Pfizer's COVID-19 Vaccines
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Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccines, including how they are 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 vaccines are only administered intramuscularly by a healthcare professional1
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The vaccines are not taken orally and are 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 vaccines 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; October 12, 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; October 18, 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; August 31, 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; August 31, 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
Authorized Use
Pfizer-BioNTech
Important Safety Information
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.
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 Pfizer-BioNTech COVID-19 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).
Myocarditis and Pericarditis
Myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine.
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 Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow‑up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long‑term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
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 Pfizer-BioNTech COVID-19 Vaccine.
Limitation of Effectiveness
Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Adverse Reactions
Primary Series Adverse Events:
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 (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%).
Post Authorization Experience
Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.
Myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Pfizer-BioNTech COVID-19 Vaccine.
Before administration of Pfizer-BioNTech COVID-19 Vaccine, please click to see
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Now Authorized: Effective 12/08/22
Emergency Use Authorization
Emergency uses of
Changes include but are not limited to the following sections:
New Language in Teal
1 Authorized Use
Pfizer-BioNTech COVID-19 Vaccine and
This EUA Prescribing Information pertains only to
2.3 Vaccination Schedule
The
Dose 1:
Dose 2:
Dose 3:
Dose 1 and Dose 2 (Pfizer-BioNTech COVID-19 Vaccine) are administered 3 weeks apart. Dose 3 (
Individuals who will turn from 4 years to 5 years of age between any doses in the primary series may receive either:
6 OVERALL SAFETY SUMMARY
. . .
The safety of
- safety data from a clinical study which evaluated primary vaccination with
Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months through 4 years of age, - safety data from clinical studies which evaluated primary vaccination with
Pfizer-BioNTech COVID-19 Vaccine in individuals 5 years of age and older, and - postmarketing safety data with the
Pfizer-BioNTech COVID-19 Vaccine.
The safety of the
- safety data from a clinical study which evaluated a booster dose with 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) in individuals greater than 55 years of age,- The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the
Pfizer-BioNTech COVID-19 Vaccine are relevant to thePfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
- The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the
- safety data from clinical studies which evaluated primary vaccination with
Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older and - safety data from clinical studies which evaluated booster vaccination with
Pfizer-BioNTech COVID-19 Vaccine (previously, but no longer, authorized) in individuals 5 years of age and older, and - postmarketing safety data with the
Pfizer-BioNTech COVID-19 Vaccine and thePfizer-BioNTech COVID-19 Vaccine, Bivalent.
In a clinical study (Study 3) in participants 6 through 23 months of age who received
In a clinical study (Study 3) in participants 2 through 4 years of age who received Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA), 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%).
The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. The bivalent vaccine (Original and Omicron BA.1) contained
Expiry Update: Effective 12/08/22
Expiry dates included in product labeling for maroon cap, orange cap, and gray cap presentations of
Verify the vials (including labels) prior to preparation and administration to help avoid dosing errors. Check gray cap, orange cap, and maroon cap vial labels to ensure that the name on the vial states “
Regardless of storage condition, the maroon cap, orange cap, and gray cap vaccines should not be used after 18 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 below. I will check back for further updates.
