for COMIRNATY prefilled syringes1,2*
for COMIRNATY prefilled syringes1,2*12-month refrigerated storage
Introduction & FAQs
COMIRNATY Dosing
for ≥12 Years
COMIRNATY Dosing
for 5-11 Years
Tab Number 4
Tab Number 5
COMIRNATY comes in 2 age-appropriate dosing presentations
- COMIRNATY single-dose glass prefilled syringes (labeled with gray borders) for individuals 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and for individuals 65 years of age and older
- COMIRNATY single-dose vials (blue caps and labeled with blue borders) for individuals 5 through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19
prefilled syringes are a well-stocked COVID-19
vaccine3-5†
prefilled syringes are a well-stocked COVID-19 vaccine3-5†COMIRNATY
Available for eligible individuals 12 years of age and older.1
View dosing information
Available for eligible individuals 5-11 years of age.1
View dosing information
There are two dosing presentations for COMIRNATY:
For eligible individuals ≥12 years, COMIRNATY prefilled syringes are refrigerator stable at 2°C to 8°C (35°F to 46°F) for 1 year from date of manufacture to the expiration date printed on the carton and the syringe labels.1,2
For eligible individuals aged 5-11 years, COMIRNATY single-dose vials can be kept in a ULT freezer (-90ºC to -60ºC [-130ºF to -76ºF]) for up to 18 months. If vial is frozen, thaw vial in the refrigerator (2°C to 8°C [35°F to 46°F] for up to 2 hours) or at room temperature (up to 25°C [77°F] for 30 minutes). Once thawed, it can be refrigerated (2°C to 8°C [35°F to 46°F]) for up to 10 weeks.1,6
See full dosing for ≥12 years here and 5-11 years here.
For eligible individuals ≥12 years, COMIRNATY prefilled syringes are refrigerator stable for 1 year from date of manufacture to the expiration date printed on the carton and the syringe labels.1,2
For eligible individuals aged 5-11 years, COMIRNATY single-dose vials can be kept in ULT storage for up to 18 months and are good refrigerated for up to 10 weeks.1,6
See full dosing for ≥12 years here and 5-11 years here.
COMIRNATY prefilled syringes (for eligible individuals ≥12 years) must not exceed 12 hours out of refrigeration at 8ºC to 25ºC (46ºF to 77ºF).1‡§
Once thawed, COMIRNATY single-dose vials (for eligible individuals 5-11 years) must not exceed 12 hours out of refrigeration at 8ºC to 25ºC (46ºF to 77ºF).1‡||
See full dosing for ≥12 years here and 5-11 years here.
For eligible individuals ≥12 years, COMIRNATY prefilled syringes expire 1 year from the date of manufacture, on the date printed on the carton and the syringe labels.1,2
For eligible individuals aged 5-11 years, COMIRNATY single-dose vials, 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. Cartons of 10 single-dose vials may take up to 2 hours to thaw at this temperature. Once thawed, they should not be refrozen.1,6
See full dosing for ≥12 years here and 5-11 years here.
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Prefilled syringes are available for those1:
- 65 years of age and older, or
- 12-64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19
12-month refrigerated storage for COMIRNATY prefilled syringes1,2*
| COMIRNATY for ≥12 years Single-dose glass prefilled syringe • DO NOT FREEZE1 |
|
|---|---|
| Approved use1 |
|
| Verify syringe label1 |  |
| Dose1 | 30 mcg |
| Dose volume1 | 0.3 mL |
| COMIRNATY for ≥12 years Single-dose glass prefilled syringe • DO NOT FREEZE1 |
|
|---|---|
| Approved use1 |
|
| Verify syringe label1 |  |
| Dose1 | 30 mcg |
| Dose volume1 | 0.3 mL |
| Storage conditions: prefilled syringes | |
|---|---|
| Total time out of refrigeration1 | The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F) must not exceed 12 hours |
| Refrigerator stable for up to 12 months1,2 | DO NOT FREEZE. COMIRNATY prefilled syringes are refrigerator stable at 2°C to 8°C (35°F to 46°F). Do not use the vaccine after the expiration date printed on the prefilled syringes and cartons |
For additional information, please see Full Prescribing Information and Patient Information.
Step 1: Verify
- Verify that the label on the prefilled syringe states the correct Formula year
- Glass prefilled syringes are supplied in a carton containing 10 syringes
- Single-dose syringes for individuals 12 years and older are labeled with gray borders
- If prefilled syringe has been frozen, discard
Step 2: Prepare
- Do not shake
- Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock, and attach a sterile needle
- Use immediately. If COMIRNATY cannot be used immediately after cap is removed, it must be used within 4 hours
Step 3: Inspect
- Inspect prefilled syringes for particulate matter and discoloration prior to administration
- The vaccine will be a white to off-white suspension
- Do not administer if vaccine is discolored or contains particulate matter
Step 4: Administer
- For the prefilled syringe, intramuscularly administer the entire volume to deliver a single 0.3-mL dose
- For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of COMIRNATY at least 2 months after the last dose of a COVID-19 vaccine
Introduction & FAQs
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COMIRNATY for 5-11 Years
(5-11 Years)*
Ages 5-11 Years
| Storage conditions: single-dose vials | |
|---|---|
| Approved use1 | 5-11 years of age with at least 1 underlying condition than puts them at high risk for severe outcomes from COVID-19 |
| Verify syringe label1 | Confirm product is in vial with blue cap with blue borders |
| Dose1 | 10 mcg |
| Dose volume1 | 0.3 mL |
| COMIRNATY for 5-11 years Single-dose vial • DO NOT REFREEZE THAWED VIALS1 |
|
|---|---|
| Approved use1 | 5-11 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19 |
| Verify syringe label1 | Confirm product is in vial with blue cap with blue borders |
| Dose1 | 10 mcg |
| Dose volume1 | 0.3 mL |
| Storage conditions: single-dose vials | |
|---|---|
| Total time out of refrigeration1 | The total time out of refrigeration (at temperatures between 8°C and 25°C [46°F and 77°F]) must not exceed 12 hours |
| Refrigerator1 | 10 weeks
|
| Ultra-low temperature (ULT) freezer1,6 | 18 months storage in a ULT freezer (-90°C to -60ºC [-130ºF to -76ºF]) |
For additional information, please see Full Prescribing Information and Patient Information.
DO NOT DILUTE
COMIRNATY is a suspension for injection, for intramuscular use only.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
- Single-dose vials for eligible individuals 5 through 11 years of age have blue caps and labels with blue borders
- Blue cap vials are supplied in a carton of 10 singIe-dose vials
- Each single-dose vial contains 1 dose of 0.3 mL (no dilution required)
Step 2: Confirm Formula and Thaw Vials
- Verify that the label on the vial states the correct Formula year
- Take out of refrigerator or thaw
- If vial is frozen, thaw vial in the refrigerator (2ºC to 8ºC [35ºF to 46ºF] for up to 2 hours) or at room temperature (up to 25ºC [77ºF] for 30 minutes)
Step 3: Preparation
- Prior to use, mix by inverting vial gently 10 times. Do not shake
- Withdraw a single 0.3-mL dose using a sterile needle and syringe
- Discard vial and any excess volume
Step 4: Administer
- COMIRNATY is administered as a single dose
- Visually inspect for particulate matter and discoloration prior to administration
- The vaccine will be a clear to slightly opalescent suspension
- Do not administer if vaccine is discolored or contains particulate matter
- Administer the 0.3-mL dose intramuscularly immediately after preparation
- For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of COMIRNATY at least 2 months after the last dose of a COVID-19 vaccine
COMIRNATY for ≥12 Years
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Hypothetical Patient Profiles
Orders for 2024-2025 formula COVID-19 vaccines by BioNTech and Pfizer can be placed by eligible healthcare professionals directly with Pfizer through Pfizer Prime online or by calling 1-800-533-4535.
Dosing and administration