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Pfizer-BioNTech COVID-19 Vaccine Authorized for Emergency Use:
The Pfizer- BioNTech COVID - 19 have been conditionally authorized by Saudi Food and Drug authority .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.
Formulation |
12 years of age and older |
12 years of age and older |
12 years of age and older |
5 through 11 years of age |
5 through 11 years of age |
6 months through 4 years of age |
|---|---|---|---|---|---|---|
Vial |
Multi-dose Vial |
Multi-dose Vial |
Single- and Multi-dose Vial |
Multi-dose Vial |
Multi-dose Vial |
Multi-dose Vial |
Vial Cap Color |
Purple |
Gray |
Gray |
Orange |
Orange |
Maroon |
EUA Fact Sheet for Vaccination Providers |
||||||
Dosage |
30 mcg |
30 mcg |
Original 15 mcg and Omicron BA.4/BA.5 15 mcg |
10 mcg |
Original 5 mcg and Omicron BA.4/BA.5 5 mcg |
3 mcg |
Injection Volume per Dose |
0.3 mL |
0.3 mL |
0.3 mL |
0.2 mL |
0.2 mL |
0.2 mL |
Dilution |
Dilution required |
NO DILUTION |
NO DILUTION |
Dilution required |
Dilution required |
Dilution required |
Amount of Diluent |
1.8 mL |
NO DILUTION |
NO DILUTION |
1.3 mL |
1.3 mL |
2.2 mL |
Doses per Vial |
6 doses per vial |
6 doses per vial |
Single-dose Vial: 1 dose per vial |
10 doses per vial |
10 doses per vial |
10 doses per vial |
Fill Volume per Vial |
0.45 mL |
2.25 mL |
2.25 mL |
1.3 mL |
1.3 mL |
0.4 mL |
Storage |
Conditions |
|||||
Ultra-Low-Temperature (ULT) Freezer (-90°C to -60°C) |
18 months (shelf life)a |
18 months (shelf life)b |
18 months (shelf life)b |
18 months (shelf life)b |
18 months (shelf life)b |
18 months (shelf life)b |
Freezer Storage Time |
2 weeks |
DO NOT STORE |
DO NOT STORE |
DO NOT STORE |
DO NOT STORE |
DO NOT STORE |
Refrigeration Storage Time |
1 month |
10 weeks |
10 weeks |
10 weeks |
10 weeks |
10 weeks |
Room Temperature |
2 hours prior to dilution |
12 hours prior to first puncture |
12 hours prior to first puncture |
12 hours prior to dilution |
12 hours prior to dilution |
12 hours prior to dilution |
After First Puncture |
Discard after 6 hours |
Discard after 12 hours |
Discard after 12 hours |
Discard after 12 hours |
Discard after 12 hours |
Discard after 12 hours |
Package Size |
195 vials |
10 vials |
10 single-dose vials or 10 multi-dose vials |
10 vials |
10 vials |
10 vials |
*Diluent: sterile 0.9% Sodium Chloride Injection, USP. Bacteriostatic saline or other diluents must NOT be used.
aRegardless 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.
bRegardless of storage condition, vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons.
Pfizer-BioNTech COVID-19 Vaccine
Authorised Use
Pfizer-BioNTech COVID-19 Vaccine is authorised for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.
Interchangeability (Primary Series for Individuals 12 Years of Age and Older)
When prepared according to their respective instructions for use, the EUA-authorised Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.
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)
Authorised Use
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorised for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older.
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 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), 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
For 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), Orange Cap, the vial label includes an orange border
For 6 months through 4 years of age Dilute Before Use, Maroon Cap, the vial label includes a maroon 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
Contact Pfizermedicalinformation.com
EUA Fact Sheet Updates
Please be aware that Pfizer-BioNTech COVID-19 Vaccine is now available in 6 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 22 December 2022
Updated shelf life for all formulations. Please see the Shelf Life & Storage page of this website for more information.
Available data supporting transportation of thawed vials increased up to 48 hours.
Click below to view:
• 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 - 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap
• EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Orange Cap
• EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), Orange Cap
• EUA Fact Sheet for Vaccination Providers - 6 months through 4 years of age Dilute Before Use, Maroon Cap
For healthcare professionals only