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This email is being sent to local health officers, tribal health directors, COVID-19 vaccinators, COVID-19 vaccine stakeholders, HERC coordinators, and key DHS staff.
Bivalent COVID-19 Vaccines for New Pediatric Age Groups
If authorized by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) anticipates a recommendation for bivalent COVID-19 vaccine for additional pediatric age groups in early to mid-December. Bivalent COVID-19 vaccine products expected to be under consideration in December include the bivalent Pfizer vaccine for children aged 6 months through 4 years and bivalent Moderna vaccine for children aged 6 months through 5 years.
An updated version of the CDC Fall COVID-19 Vaccination Planning Guide is now available. The updated guide includes details about bivalent COVID-19 vaccines as boosters for children aged 6 months through 4 or 5 years. Note that the vaccine indications in the updated guide are not final and may change, and it will be important to review the Emergency Use Authorization (EUA) and the updated clinical considerations from CDC to ensure vaccination is administered appropriately.
Training Refresher Video: Correction to Replacement Card Guidance
On Thursday, November 17, 2022, training and enrollment refresher emails were sent out to the primary and backup coordinators of all COVID-19 vaccinator locations that enrolled prior to January 1, 2022. DHS wants to make vaccinators aware of a minor error in the vaccinator refresher training video regarding the replacement of vaccination record cards.
On the first of two slides titled “Patient Education Requirements” in the training video, which is located about 75% into the narrated presentation, it is incorrectly noted that “a provider should not issue a replacement vaccine card for doses that were not administered at their location”. This is incorrect and it has been corrected with the current guidance on the corresponding slide deck on numbered slide 29.
If your location has not already done so, please complete the training and enrollment refresher process and submit one attestation survey prior to December 16, 2022. If your primary and/or backup coordinator(s) have not received or misplaced their invitation email with the survey link, please contact DHSCOVIDVaccinator@wi.gov with the subject line “Training and Enrollment Refresher”.
Pfizer Minimum Order Quantity
On Thursday, December 1, 2022, the minimum order quantity (MOQ) for multi-dose vial Pfizer-BioNTech COVID-19 vaccines changed from 300 to 180 doses.
Moderna Shelf-Life Extension
The FDA has extended the shelf-life of the following Moderna 10 products. Moderna has verified the new expiry dates below and updated the Moderna Vial Expiration Checker.
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Count
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Lot Number
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Old Expiration Date
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New Expiration Date
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1
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054A22A
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2022-11-01
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Feb 1, 2023
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2
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055A22A
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2022-11-02
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Feb 2, 2023
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|
3
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057A22A
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2022-11-06
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Feb 6, 2023
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|
4
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056A22A
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2022-11-07
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Feb 7, 2023
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|
5
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059A22A
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2022-11-09
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Feb 9, 2023
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6
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058A22-2A
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2022-11-10
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Feb 10, 2023
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7
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060A22A
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2022-11-10
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Feb 10, 2023
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8
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014B22A
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2022-11-11
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Feb 11, 2023
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9
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015B22A
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2022-11-12
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Feb 12, 2023
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10
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016B22A
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2022-11-13
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Feb 13, 2023
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11
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017B22A
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2022-11-14
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Feb 14, 2023
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|
12
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011B22A
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2022-11-18
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Feb 18, 2023
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Moderna is also expecting to announce shelf-life extensions of 29 additional lots (Moderna 10 and Moderna 5 monovalent products):
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Count
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Lot Number
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Current Expiration Date
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Doses Per Vial
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13
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AR4504B
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11/13/2022
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5DV
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14
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AR5186C
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11/17/2022
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5DV
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15
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013B22A
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11/22/2022
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10DV
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16
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052B22A
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11/23/2022
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10DV
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17
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064A22A
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11/24/2022
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5DV
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18
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AR6965B
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11/25/2022
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5DV
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19
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AR7204B
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11/25/2022
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5DV
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20
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AR7205B
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11/25/2022
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5DV
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21
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060B22A
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11/26/2022
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10DV
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22
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AR7479B
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11/26/2022
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5DV
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23
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061B22A
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11/27/2022
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10DV
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24
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083B22A
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11/28/2022
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10DV
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25
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068A22A
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11/28/2022
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5DV
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|
26
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063B22A
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12/2/2022
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10DV
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27
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059B22A
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12/3/2022
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10DV
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28
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063B22-2A
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12/4/2022
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10DV
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29
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074B22A
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12/11/2022
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10DV
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30
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071B22A
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12/12/2022
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10DV
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31
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072B22A
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12/13/2022
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10DV
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32
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047C22A
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12/24/2022
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10DV
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|
33
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019B22A
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12/28/2022
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10DV
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|
34
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042C22A
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12/30/2022
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10DV
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35
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015C22A
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12/30/2022
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5DV
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|
36
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AR8365B
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12/30/2022
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5DV
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|
37
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016C22A
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12/31/2022
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5DV
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38
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044C22A
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1/1/2023
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10DV
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|
39
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017C22A
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1/1/2023
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5DV
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|
40
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019C22A
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1/3/2023
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5DV
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|
41
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018C22A
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1/9/2023
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5DV
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If you have any of the monovalent Moderna COVID-19 vaccines above in stock:
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Isolate and clearly label the vaccine in storage to avoid distribution errors and wait and see if their inventory is expiry extended.
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If storage space for isolation of vaccine is limited, dispose of expired vaccine in accordance with state and local regulations to avoid administration errors. Vaccinators may order replacements of expired monovalent mRNA COVID-19 vaccine.
- Please be aware that monovalent vaccines may be short dated, pending approval of primary series bivalent.
- Vaccinators are encouraged to maintain stock of monovalent COVID-19 vaccines to provide a safety net of availability until bivalent primary doses are approved.
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There will be rolling expiry dates of adult monovalent products. Replacement orders should be small and frequent to avoid large expiry losses.
Pfizer is expected to announce shelf-life extensions of all their TRIS products (all gray, orange, and maroon for both monovalent and bivalent products). More information will be provided as it is made available.
Reporting COVID-19 Vaccine Wastage
Report COVID-19 vaccine wastage in WIR if doses have gone past the beyond use date (BUD), are unable to be drawn from a vial, are spoiled due to temperature excursions, or are not able to be used for any other reason.
DHS continues to strongly recommend that vaccinators pursue a “no wasted opportunity” goal as part of their vaccination efforts rather than “no wasted doses”. Vaccinators should leverage every opportunity to vaccinate individuals against COVID-19, even if it means opening a vial to administer only a couple doses.
Controlant Sunsetting
Onsite temperature monitoring for Pfizer vaccines (after product acceptance) ended on November 28, 2022.
All Pfizer COVID-19 vaccine shipments will continue to have supporting Controlant DDL in-transit temperature monitoring.
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Vaccinators can no longer use the Pfizer COVID-19 vaccine medium ULT shippers for temporary storage after receipt.
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All vaccinators still using Controlant DDLs for in-house temperature monitoring must install their own appropriate storage and monitoring equipment.
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All vaccinators should return Controlant DDLs using the return shipping label.
Temperature data must be downloaded and stored. You must keep all logs for 3 years per the COVID-19 Vaccination Program Provider Agreement. For assistance, please reach out to support@controlant.com.
Digital Data Loggers: A Quick Refresher
CDC requires COVID-19 vaccine temperatures to be monitored using a “digital data logger” (DDL). A DDL provides the most accurate storage unit temperature information, including details on how long a unit has been operating outside the recommended temperature range (referred to as a “temperature excursion”). DDLs using a buffered temperature probe provide the most accurate way to measure actual vaccine temperatures.
Always use DDLs with a current and valid Certificate of Calibration Testing. Note that not all DDLs can measure ultra-cold temperatures.
Use DDLs with the following features:
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Detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®)
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Alarm for out-of-range temperatures
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Low-battery indicator
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Current, minimum, and maximum temperature display
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Recommended uncertainty of +/-0.5° C (+/-1° F)
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Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes
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Current and valid Certificate of Calibration Testing
For more information about temperature monitoring equipment, please see section three of the Vaccine Storage and Handling Toolkit as well as the COVID-19 Vaccine Storage and Handling Addendum beginning on page 50.
New and Updated Resources
Updated Communication and Education Resources from CDC
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MMWR: Effectiveness of Bivalent mRNA Vaccines in Preventing Symptomatic SARS-CoV-2 Infection — Increasing Community Access to Testing Program, United States, September–November 2022
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MMWR: Sociodemographic Variation in Early Uptake of COVID-19 Vaccine and Parental Intent and Attitudes Toward Vaccination of Children Aged 6 Months–4 Years — United States, July 1–29, 2022
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An updated version of the CDC Fall COVID-19 Vaccination Planning Guide is now available. The updated guide includes details about bivalent COVID-19 vaccines as boosters for children aged 6 months through 4 or 5 years.
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Note: the vaccine indications in the updated guide are not final and may change, and it will be important to review the EUA and the updated clinical considerations from CDC to ensure vaccination is administered appropriately.
In Case You Missed It
Wisconsin COVID-19 Vaccine Program Webinar Schedule
Bi-weekly COVID-19 Vaccine Program updates are held every other Tuesday from 11 a.m.-12 p.m. The next webinar will be held on Tuesday, December 13.
Register for the meeting series here. Watch recordings of past webinars here.
Pfizer Single Dose Vials Available for Direct Ship Order Only
A limited amount of the bivalent gray cap Pfizer COVID-19 vaccine for people 12 years of age or older is available for ordering in single-dose vials (SDVs). Vaccinators can place orders for Pfizer SDVs by completing the COVID-19 Vaccine Ordering Survey. This is the same process that is used to order all COVID-19 vaccines.
SDVs shipping and ordering
Due to limited quantities, the Pfizer SDVs are available for direct ship order only. Wisconsin vaccinators can only put in one order for 50 doses, until further notice. If vaccinators want less than 50 doses, they are instructed to list the extra doses they receive on the Wisconsin COVID-19 Vaccine Exchange. At this time, this product will not be distributed from the regional distribution hubs.
Vaccinator Training and Enrollment Refresher Requirement
Vaccinators should be aware that all COVID-19 vaccination sites that registered with the Wisconsin Department of Health Services (DHS) prior to January 1, 2022, must complete a training and enrollment refresher.
The primary and backup coordinators listed on each location’s enrollment paperwork should have received an email with more information about the refresher. The email also includes a customized link to complete the attestation survey.
Note that vaccination support staff who have recently completed the full list of COVID-19 training requirements within the last six months do not need to complete the refresher. Once all required staff have completed the training refresher, only one attestation survey must be submitted on behalf of the location. For more information, or to report concerns regarding the training and enrollment refresher program or the above referenced email, please contact DHSCOVIDVaccinator@wi.gov.
Novavax Office Hours
Please use the following link to register for a Novavax office hours session on the new booster Emergency Use Authorization (EUA) approval for the Novavax COVID-19 vaccine. Sessions are held on Wednesdays at 11:00 a.m.
Any questions can be directed toward Novavax Customer Service at 1-855-239-9174.
Pfizer COVID-19 Vaccine Medical Updates and Immunization Site Training Sessions
Pfizer Vaccines US Medical Affairs continues to lead Medical Updates and Immunization Site Training Sessions for all healthcare providers on the proper use of the Pfizer BioNTech COVID-19 vaccine.
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New training on the Pfizer COVID-19 bivalent vaccine as a booster dose
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Use of each vaccine presentation, including storage, handling, preparation, and administration
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Question and answer session
To access dates and links for upcoming training sessions, please visit:
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