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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 & Storage

5 through 11 years of age

Dosing & Administration

Shelf Life & Storage

Vaccine Formulations Guide

Children 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 [countries to program the hyperlink based on website URL]	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.

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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 [email protected] 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.

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.