The Maine Immunization Program has been informed that the CDC will be replacing the current Pfizer 12y+ vaccine allocations with Pfizer’s new refrigerated 12y+ vaccine (NDC 00069-2377-10). This presentation will come in a carton of 10 manufacturer-filled syringes (MFS).
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This new presentation MUST BE STORED BETWEEN 2°C and 8°C (36°F and 46°F). Do NOT store at ultra-cold or standard freezer temperatures.
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These manufacturer-filled syringes can be used through the expiration date printed on the carton. The 10-week beyond-use date (BUD) for refrigerator storage does not apply.
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This guidance applies to this presentation ONLY, 12yrs+.
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Pfizer-BioNTech COVID-19 vaccines for children aged 6m-4y and 5-11y, which are shipped to providers in CDC’s programs directly from Pfizer on dry ice and can be stored at either ultracold temperatures until expiry or up to 10 weeks at 2-8°C.
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The carton includes a bright pink stripe that includes the words “DO NOT FREEZE” to alert the provider about the storage and handling requirements for this vaccine.
COMIRNATY Single Dose Glass Prefilled Syringes
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If glass prefilled syringe has been frozen, discard.
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Do not shake.
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Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile needle.
COMIRNATY Single Dose Plastic Prefilled Syringes
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If syringes are frozen, thaw syringe in the carton in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)]. Do not remove syringe from carton to thaw.
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Do not shake.
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Remove tip cap and attach a sterile needle.
Pfizer 6mo-11yrs remains the same, no changes to either presentation.
COMIRNATY Single Dose Vials:
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Verify that the vial states 2023-2024 Formula.
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If vials are frozen, thaw vial in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)].
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Prior to use, mix by inverting vial gently 10 times. Do not shake.
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Withdraw a single 0.3 mL dose using a sterile needle and syringe.
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Discard vial and any excess volume.
Of note: Pfizer will continue to allow providers to privately order the original manufacturer-filled syringes (MFS) for age 12+. Therefore, providers may have BOTH presentations – MFS with a 10-week BUD and MFS that can be used through the expiration date- in their storage units.
If this occurs, educate staff on the different storage requirements and strategies to prevent potential errors. CDC COVID-19 clinical materials are being updated to include this new presentation and storage guidance.
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In response to the significant damage from Maine's storm earlier this week which resulted in extensive power outages, MIP vaccine ordering through McKesson was halted.
As we recover from the storm and power is restored, ordering through McKesson will resume.
Vaccine orders placed on December 21st or after will start processing at 9:00 am today. Any orders placed between the 18th and 20th will be held until noon on Tuesday, December 26 to allow providers to cancel, if needed.
ImmPact Help Desk Contact Information:
207-287-3006
ImmPact.Support@maine.gov
During any inclement weather where there is a threat of power loss, it is important to always follow your Emergency Storage and Handling Plan to ensure that your vaccines are stored safely or if necessary, moved to your designated back-up location that is equipped with a generator.
During this week's storm we sent a communication to providers highlighting what to do if a power failure occurs and what to do when power is restored. We urge you to familiarize yourself with this information, as we experience more storms throughout the winter.
As always, for any out-of-range temperature excursion, providers must contact each vaccine manufacturer and the Maine Immunization Program. For best steps to follow, please see the Temperature Excursion Guide.
Additional Resources:
McKesson shipments may arrive on any day of the week, including Mondays, based on the way business hours are entered in VTrckS. Below is the shipping schedule for routine vaccines as stated in the current contract. Note: Orders may ship out more quickly than the “Order Shipped By” day shown in this table.
 *Business/Ship day ends at 12:00 noon Local Distribution Center Time. Orders must be received prior to this cutoff to be considered received on a given day.
**Orders shipped by applies to providers with normal business hours only. Providers with hours other than normal business hours should not that order may ship out later than the “order shipped by” date shown in this table.
***Flu and direct ship vaccines cannot be shipped as priority and therefore should not be marked as priority in VTrckS. |
