NEW! Single Dose Vial Ordering
Pfizer-BioNTech COVID-19 vaccine for people 12 years of age or older will be available in single-dose vials (SDV). The SDV presentation is in response to widespread requests from vaccine administration partners for the greater flexibility this presentation provides. Please see the message from ASPR regarding ordering, distribution, storage and handling, and other important information about this product.
The new Pfizer bivalent single dose vial (SDV) booster will be available in the Vaccine Allocation Ordering System (VAOS) for providers to order on Friday, November 11th.
SDV do not require dilution, therefore they will not come with ancillary supplies, or additional vaccine cards. Providers should ensure consent is obtained and doses are entered into the state IIS.
Deliveries can be expected to arrive starting the following week on Monday, November 14th. This vaccine will have a grey cap and providers will need to order a minimum of 50 doses and a maximum order of 150.
NO ORDERS WILL BE DELIVERED NOVEMBER 23-27
Deliveries resume Monday, Nov. 28
All channels should plan to order early prior to the holiday week.
NEW! Syntropi Update
There has been an update in Syntropi-CRC regarding storage capacity when providers are registering to be a Vaccine Provider.
Providers are now required to input their data logger information first before they can select the type of storage unit they will be using. The system will not allow providers to move forward if they have not uploaded their corresponding certificates of calibration.
Once they input their DLC information and upload certificates they can then choose which storage unit they will be using.
NEW! COVID-19 & Immunization Schedule for Children
A CDC panel unanimously voted on October 19, 2022, to add the COVID-19 vaccine to the recommended childhood schedule.
The CDC immunization schedule is a guideline for states to adopt if they choose. It is not mandated nationally, according to the CDC.
“State laws establish vaccination requirements for school children. These laws often apply not only to children attending public schools but also to those attending private schools and daycare facilities.”
NEW! New CDC Webinar - Recommendations for Bivalent
COVID-19 Booster Dose: CDC’s COVID-19 Vaccine Webinars are brief presentations designed to provide immunization providers with the most up-to-date information on the vaccines used to fight the virus that causes COVID-19. The new Recommendations for Bivalent COVID-19 Booster Doses course discusses recommendations for a bivalent COVID-19 booster dose, the interim COVID-19 immunization schedule to date, COVID-19 vaccine products, and recommended actions for addressing bivalent and monovalent COVID-19 vaccine administration errors
REMINDER: Association of Immunization Managers’ COVID-19 Updates
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Single dose vials (Pfizer Gray Cap 12+ Bivalent Booster) are expected the week of November 28th after the Thanksgiving holiday. 50 vial (dose) min order quantity, 12 months ULT, 10 weeks in fridge, will come on dry ice.
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15 million single dose vials have been purchased in total. Rollout will likely be slow at the beginning with 1-2 million doses during initial rollout. Suggestion to prioritize rural populations, providers who are threatening to disenroll because of multidose vials, etc.
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Pfizer is looking to reduce the minimum dose ordering quantity to ~180 doses down from 300 dose minimum for their multidose gray bivalent product.
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Once COVID vaccines are commercialized, the single dose vial packages will NOT include ancillaries. Suggestion to keep and use surplus ancillaries.
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Bivalent boosters for under 5 and under 6 are likely to come after Christmas.
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Moderna is working on a smaller presentation for their bivalent booster <6 (Moderna 2 dose vials <6 bivalent booster) Pfizer has not shared what their packaging for <5 will look like.
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CDC has heard informally that ACIP will talk about bi-valent primary series COVID vaccines in January. This could mean less reliance on shelf-life extensions for primary series.
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As of November 28th, no longer support temporary storage active monitoring through DDLs (Pfizer). Programs can use supplemental funds to buy DDLs etc.
- A lot of monovalent products are dated to expire November 30th. Both Pfizer and Moderna are looking towards shelf-life extensions during the end of 2022-early 2023.
REMINDER: Thermal shippers for temporary storage of COVID-19 vaccines
Starting November 2022, providers can no longer use the Pfizer-BioNTech COVID-19 vaccine medium ULT shippers for temporary storage after receipt. Section 3.1, covering use of thermal shippers for temporary storage of COVID-19 vaccines, has been removed.
On November 24, 2022, Controlant DDLs will no longer be available for continued temporary storage temperature monitoring following the initial delivery of vaccine shipments.
Pfizer-BioNTech COVID-19 vaccine should not be stored in the thermal shipper used for vaccine distribution on the mainland U.S. after transport is complete. All Pfizer-BioNTech COVID-19 vaccine shipments have supporting Controlant DDL for in-transit temperature monitoring purpose only. Upon receipt, providers should press the ‘Stop’ button to receive their final report. Also, once the vaccine is received, it must be moved to:
- An ultra-cold freezer and maintained between -90°C and -60°C* (until the vaccine’s expiration date).
- A refrigerator and maintained between 2°C and 8°C (to be used within 10 weeks).
- Regardless of storage condition, Pfizer-BioNTech vaccines should not be used after 12 months from the date of manufacture printed on the vials and cartons, unless extended by FDA.
*Storage of the Pfizer-BioNTech vials between -96°C to -60°C is not considered an excursion from the recommended storage condition.
REMINDER: Holiday Public Vaccine Shipping
Schedule 2021-2022 for Routine Vaccines: Please see the holiday shipping schedules (awardee version and provider version) for both McKesson and Merck Direct Ship for routine vaccines.
In order to be sure to have adequate routine vaccine supply, please note dates when shipments will be held due to the upcoming holidays. Planning for December is vital; due to the carriers having high holiday volume, it is best to submit orders early to ensure you receive your vaccine within a desired time frame.
REMINDER: Novavax Monovalent COVID-19 Boosters
On October 19, 2022, CDC’s Director Dr. Walensky signed a decision memo allowing Novavax monovalent COVID-19 boosters, which target the original COVID-19 strain. This recommendation followed FDA’s granting of an emergency use authorization.
Novavax boosters may be used if recipients are unable or unwilling to receive a Pfizer or Moderna updated (bivalent) COVID-19 booster and they meet the following requirements:
- Are 18 years of age or older
- Have completed a COVID-19 vaccine primary series at least 6 months ago
- Have not gotten any other booster dose
Providers carrying Novavax should update their appointment scheduling systems to allow individuals who are unable or unwilling to receive a bivalent booster to select Novavax as a booster if they meet the requirements listed above.
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