Homepage|CVDVACCINE EUA 2.0

A new formulation of the COMIRNATY booster "12 years of age and older, Ready
to use (Original/Omicron BA.1 Cap and Package, Multi-dose vial)" was approved
on DD/MM/YY with procedure X/0000.Additional website content relevant to this
new formulation will be available on DD/MM/YY.

COMIRNATY Original/Omicron BA.1 15/15 micrograms/per dose for dispersion
for injection, for 12 years of age and older, Ready to use (Original/Omicron BA.1
Cap and Package, Multi-dose vial)
PP-CMR-GLB-0188

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

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 formulation of Pfizer-BioNTech COVID-19 Vaccine, 12 years of age and older Dilute Before Use Purple Cap when prepared according to instructions for use, is indicated for primary series only.

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	5 through 11 years of age Dilute Before Use
Vial	Multi-dose Vial	Multi-dose Vial
Vial Cap Color	Purple	Orange
EUA Fact Sheet for Vaccination Providers	EUA Fact Sheet for Vaccination Providers	EUA Fact Sheet for Vaccination Providers
Dosage	30 mcg	10 mcg
Injection Volume per Dose	0.3 mL	0.2 mL
Dilution	Dilution required	Dilution required
Amount of Diluent Needed per Vial*	1.8 mL	1.3 mL
Doses per Vial	6 doses per vial (after dilution)	10 doses per vial (after dilution)
Vial Size	2 mL	2 mL
Fill Volume per Vial	0.45 mL	1.3 mL
	Storage Conditions
Ultra-Low-Temperature (ULT) Freezer (-90°C to -60°C)	24 months (shelf life)^a	24 months (shelf life)^b
Freezer Storage Time (-25°C to -15°C)	2 weeks	DO NOT STORE
Refrigeration Storage Time (2°C to 8°C)	1 month	10 weeks
Room Temperature (8°C to 25°C)	2 hours prior to dilution (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
Package Size	195 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 18-month expiry (6 months printed on the vial plus additional 12 months for the expiry dates December 2021 through March 2022. 9 months printed on the vial plus additional 9 months for the expiry dates June 2022 through December 2022).
^‡Regardless of storage condition, vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons.

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 5 through 11 years of age Dilute Before Use, Orange Cap, the vial label includes an orange border

If you suspect the vaccine you have purchased may be counterfeit, contact us at https://www.pfizer.com/counterfeiting/frequently-asked-questions .

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

For more information

Medical Information
Visit: https://www.pmi-covid.com/en-afme/covid-19-mrna-vaccine-bnt162