A new formulation of Pfizer/BioNTech COVID-19 Vaccine "12 years and older, Ready to use (Original/Omicron BA.4-5 Grey Cap and Package, Multi-dose vial) was approved FOR BOOSTER DOSES ONLY on 12/09/22 with procedure II/143.
Additional website content relevant to this new formulation will be available soon
Pfizer-BioNTech COVID-19 Vaccine Original/Omicron BA.4-5 (15/15 micrograms)/ dose dispersion for injection, for 12 years and older, Ready to use (Grey Cap and Package, Multi-dose Vial)
PP-CVV-BHR-0005
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EUA Fact Sheet for Recipients and Caregivers - 12 years of age and older
EUA Fact Sheet for Vaccination Recipients and Caregivers - 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 - 12 years of age and older Do Not Dilute, Gray Cap
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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 & Directorate General of Pharmaceutical Affairs and Drug Control - Ministry of Health in Oman, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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 EUA to prevent 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.
Formulation |
12 years of age and older |
12 years of age and older |
---|---|---|
Vial |
Multi-dose Vial |
Single- and Multi-dose Vial |
Vial Cap Color |
Purple |
Gray |
EUA Fact Sheet for Vaccination Providers |
||
Dosage |
30 mcg |
Original 15 mcg and Omicron BA.4/BA.5 15 mcg |
Injection Volume per Dose |
0.3 mL |
0.3 mL |
Dilution |
Dilution required |
NO DILUTION |
Amount of Diluent |
1.8 mL |
NO DILUTION |
Doses per Vial |
6 doses per vial |
Single-dose Vial: 1 dose per vial |
Vial Size |
2 mL |
2 mL |
Fill Volume per Vial |
0.45 mL |
2.25 mL |
Storage Conditions |
||
Ultra-Low-Temperature (ULT) Freezer (-90°C to -60°C) |
24 months (shelf life)† |
24 months (shelf life)‡ |
Freezer Storage Time |
2 weeks |
DO NOT STORE |
Refrigeration Storage Time |
1 month |
10 weeks |
Room Temperature |
2 hours prior to dilution |
12 hours prior to first puncture |
After First Puncture |
Discard after 6 hours |
Discard after 12 hours |
Package Size |
195 vials |
10 single-dose vials or 10 multi-dose 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 15-month expiry (6 months printed on the vial plus additional 9 months for the expiry dates December 2021 through March 2022. 6 months printed on the vial plus additional 6 months for the expiry dates June 2022 through December 2022. All vials with expiry date beyond December 2022 will already reflect the 15-month shelf life).
bRegardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons.
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.
If you suspect the Pfizer-BioNTech COVID-19 Vaccine you have purchased may be counterfeit, contact us at 1-800-438-1985 or
visit https://www.pfizer.com/products/product-contact-information.
Medical Information
Visit PfizerMedicalInformationgulf.com
EUA Fact Sheet Updates