Purpose
The following product summary can be used by product providers to prepare orders for fall and winter virus season.
Presentations and Indications
- COMIRNATY (30 mcg/0.3mL glass pre-filled syringe presentation) is indicated for individuals 12 years of age and older.
- Pfizer-BioNTech COVID-19 Vaccine is indicated for individuals 5 through 11 years of age (via a 10mcg / 0.3mL single-dose vial presentation) and for individuals 6 months through 4 years of age (via a 3mcg / 0.3mL multi-dose vial (3 doses per vial) presentation).
Ordering and Return Policy
Minimum Initial Order
When ordering vaccines directly from the company, there is no minimum initial order requirement.
Pre-ordering or Reservation Programs
The reservation platform Pfizer Prime is now open for orders of COMIRNATY (2024-25 Formula) and Pfizer-BioNTech COVID-19 Vaccine (2024-25 Formula), which are pending FDA review and approval or authorization. A nominal discount is offered to customers that place a reservation. Customers that order directly on Pfizer Prime can contact Pfizer Customer Service at 1-800-666-7248. Customers can also work with their wholesaler for details on placing reservations via the wholesaler, if preferred.
Return Policy
Unopened Vaccine
For the COMIRNATY Vaccine for individuals 12 years of age and older, customers have the option to return up to 30% of their seasonal purchases, though specific terms may apply based on individual contracts.
For Pfizer-BioNTech COVID-19 Vaccine for individuals 6 months through 11 years of age, Pfizer offers a 100% return policy.
Opened Vaccine
Returns for opened Pfizer-BioNTech COVID-19 Vaccines for individuals 6 months through 4 years of age in multi-dose vials may be partial, depending on the estimated remaining contents of the vial.
For additional questions, please reach out to Pfizer Customer Service at 800-666-7248.
Storage Requirements
Multi-dose and single-dose vials
The multi-dose and single-dose vials must be stored frozen at ultra-cold temperatures (between -90⁰C and -60⁰C). Once the vials are thawed, the multi-dose and single-dose vials must be stored refrigerated (between 2⁰C and 8⁰C).
Glass single-dose pre-filled syringes
The glass single-dose pre-filled syringes for ages 12 and older must be stored refrigerated (between 2⁰C and 8⁰C); DO NOT FREEZE. The total time out of refrigeration (at temperatures between 8°C and 25°C) must not exceed 12 hours.
Diluent Type and Volume
1.1 mL of sterile 0.9% Sodium Chloride Injection, USP.
Reconstitution is required only for the Pfizer-BioNTech COVID-19 Vaccine for individuals 6 months through 4 years of age in multi-dose vials.
Shelf Life
| Shelf Life | 6 months through 4 years | 5 years through 11 years | 12 and older |
|---|---|---|---|
| Unopened, frozen vaccine | Once received, frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC until the expiration date printed on the vials and cartons. Do not store vials at -25°C to -15°C. Once vials are thawed, they should not be refrozen. | DO NOT FREEZE. | |
| Unopened, refrigerated vaccine | Once received, frozen vials may be immediately transferred to the refrigerator [2ºC to 8ºC], thawed and stored for up to 10 weeks, not to exceed the expiration date printed on the vial and cartons. If vials and cartons are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date, not to exceed the expiration date printed on the vial and cartons. | The vaccine may be stored at 2°C to 8°C until the expiration date printed on the carton and syringe labels (not to exceed 8 months). DO NOT FREEZE. | |
| Opened, refrigerated vaccine | If not previously thawed at 2ºC to 8ºC, allow multi-dose vials or single dose vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
Multi-dose or single dose vials may be stored at room temperature [8°C to 25°C] for a total of 12 hours prior to the first puncture. After dilution, multiple dose vials should be held between 2ºC to 25°C. Multi-dose vials should be discarded 12 hours after dilution.
|
After removing the tip cap and attaching an appropriate needle, the glass prefilled syringe should be used immediately. If it cannot be used immediately, it must be used within 4 hours. DO NOT FREEZE. | |
| Opened, room temperature vaccine | If not previously thawed at 2ºC to 8ºC, allow multi-dose vials or single dose vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
Multi-dose or single dose vials may be stored at room temperature [8°C to 25°C] for a total of 12 hours prior to the first puncture. After dilution, multiple dose vials should be held between 2ºC to 25°C. Multi-dose vials should be discarded 12 hours after dilution.
|
After removing the tip cap and attaching an appropriate needle, the glass prefilled syringe should be used immediately. If it cannot be used immediately, it must be used within 4 hours. DO NOT FREEZE. | |
Additional Information
Both COMIRNATY (2023-2024 Formula) and Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) are currently available.
The FDA provided guidance on the preferred KP.2 strain for the COVID-19 vaccines (2024-25 Formula) on June 13, 2024: https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024. The updated 2024-25 formula of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine are pending FDA review for approval and authorization for emergency use.
For multi-dose vials for ages 6 months through 4 years of age and single-dose vials for ages 5 years through 11 years of age shipped at ultra-low temperatures, the shipping container includes a real-time temperature monitor and documentation to inform the provider how to operate the monitor and receive a quality disposition report by e-mail informing them of the viability of the product. If the product is not viable or if the provider has any questions, they should contact Pfizer Customer Service at 800-666-7248.