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EUA Fact Sheets for Vaccination Providers

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

EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute
Before Use, Orange Cap

EUA Fact Sheets for Recipients

EUA Fact Sheet for Recipients and Caregivers ‐ 12 years of age and older

EUA Fact Sheet for Recipients and Caregivers ‐ 12 years of age and older

EUA Fact Sheet for Recipients and Caregivers ‐ 5 through 11 years of age

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HomeShelf Life & StorageDosing & Administration12 years of age and older5
through 11 years of ageSafety & EfficacyResources


Pfizer-BioNTech COVID-19 Vaccine Authorised for Emergency Use: 
Emergency uses of the vaccine have not been approved or licensed by FDA, but
have been authorised 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 authorised for the duration of the
declaration that circumstances exist justifying the authorisation of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorisation revoked sooner.



12 years of age and older
Dosing & Administration
Shelf Life & Storage5 through 11 years of age
Dosing & Administration
Shelf Life & StorageVaccine Formulations GuideChildren ages 5 through 11 years
old should only be vaccinated with the 5 through 11 years of age 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.

The 2 formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years
of age and older, when prepared according to their respective instructions for
use, can be used interchangeably.

Refer to the information outlined below to understand the differences across age
groups and formulations

Formulation

12 years of age and older
Dilute Before Use

12 years of age and older
Do Not Dilute

5 through 11 years of age
Dilute Before Use

Vial

Multi-dose Vial

Multi-dose Vial

Multi-dose Vial

Vial Cap Color

Purple

Gray

Orange

EUA Fact Sheet for Vaccination Providers

EUA Fact Sheet for Vaccination Providers
[countries to program the hyperlink based on website URL]

EUA Fact Sheet for Vaccination Providers
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EUA Fact Sheet for Vaccination Providers
[countries to program the hyperlink based on website URL]

Dosage

30 mcg

30 mcg

10 mcg

Injection Volume per Dose

0.3 mL

0.3 mL

0.2 mL

Dilution

Dilution required

NO DILUTION

Dilution required

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)

Vial Size

2 mL

2 mL

2 mL

Fill Volume per Vial

0.45 mL

2.25 mL

1.3 mL

Storage Conditions

Ultra-Low-Temperature (ULT) Freezer (-90°C to -60°C)

9 months (shelf life)†

9 months (shelf life)‡

9 months (shelf life)‡

Freezer Storage Time
(-25°C to -15°C) 

2 weeks

DO NOT STORE

DO NOT STORE

Refrigeration Storage Time
(2°C to 8°C) 

1 month

10 weeks

10 weeks

Room Temperature
(8°C to 25°C)

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)

Discard after 6 hours

Discard after 12 hours

Discard after 12 hours


Package Size

195 vials

10 vials

10 vials

*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 for the expiry
dates until February 2022. All vials with an expiry date beyond February 2022
will already reflect the 9-month shelf life).
‡Regardless of storage condition, vaccines should not be used after 9 months
from the date of manufacture printed on the vial and cartons.

DOWNLOAD THIS GUIDE
Authorised Use

 The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization
(EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older to
provide:

 * a 10 mcg modRNA 2-dose primary series to individuals 5 through 11 years of
   age

 * a 30 mcg modRNA 2-dose primary series to individuals 12 years of age and
   older

 * a 10 mcg modRNA third primary series dose to individuals 5 through 11 years
   of age who have been determined to have certain kinds of immunocompromise

 * a 30 mcg modRNA third primary series dose to individuals 12 years of age and
   older who have been determined to have certain kinds of immunocompromise

 * a 30 mcg modRNA single booster dose to individuals 12 years of age and older
   who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine

 * a 30 mcg modRNA single booster dose to individuals 18 years of age and older
   who have completed primary vaccination with another authorised or approved
   COVID-19 vaccine. The dosing interval for the heterologous booster dose is
   the same as that authorised for a booster dose of the vaccine used for
   primary vaccination

Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine

 * 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
   
   * The vaccine is only administered intramuscularly by a healthcare
     professional
   
   * The vaccine is not taken orally and is not available in a capsule or tablet
     form

 * Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and
   BioNTech names on the label and are dispensed in a vial as follows:
   
   * For 12 years of age and older Dilute Before Use, Purple Cap, two versions
     of the vial label are in current circulation - with or without a purple
     border
   
   * For 12 years of age and older Do Not Dilute, Gray Cap, the vial label
     includes a gray border
   
   * For 5 through 11 years of age Dilute Before Use, Orange Cap, the vial label
     includes an orange border

 * Ensure the safety of the vaccine vials by limiting access to only authorised
   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-authorised vaccination centers – such as doctor’s offices,
   authorised 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-authorised vaccination sites. Individual doses are not for sale

 If you suspect the vaccine you have purchased may be counterfeit, contact us at
[INSERT LOCAL COUNTRY INFORMATION] .

For more information

If you suspect COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) you have
purchased may be counterfeit, contact Customer Service at 0860 Pfizer (734937)

Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via https://www.pfizersafetyreporting.com/#/en or
ZAF.AEReporting@pfizer.com or call +27 0860 PFIZER (734 937)] and include
batch/Lot number if available

Submit medical Inquiry with link to the following MI contact details:
https://www.pfizermedicalinformation.co.za/en-za/covid-19-mrna-vaccine-bnt162

Contact

Manufactured for BioNTech
Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany

Manufactured by Pfizer Inc.
New York, NY 10017

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary
mRNA technology, was developed by both BioNTech and Pfizer.

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©2022 Pfizer Inc. All rights reserved. January 2022. PP‑CVV‑GLB‑0173

This site is intended for Healthcare Professionals. The products discussed in
the site may have different product labeling in different countries. The
information provided is for educational purposes only.



EUA Fact Sheet Updates

Please be aware that Pfizer-BioNTech COVID-19 Vaccine is now available in three
formulations. For additional information on differences across age groups and
formulations please see Vaccine Formulations Guide on the home page of this
website.


Label Update: Effective 03 Jan 2022

2.3 Vaccination Schedule
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 to individuals 12 years of age and older. 

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:
    •    EUA Fact Sheet for Vaccination Providers - 12 year 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
    •    EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age
Dilute Before Use, Orange Cap

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