As plans are being made for the availability of pediatric COVID-19 bivalent vaccine boosters in Wisconsin, the Wisconsin Department of Health Services (DHS) is providing COVID-19 vaccinators with the latest expected arrival and ordering information.
Pending CDC recommendation, pediatric COVID-19 bivalent vaccine boosters are expected to be available by mid-to-late October
It is expected that the Centers for Disease Control and Prevention (CDC) will soon recommend pediatric COVID-19 bivalent vaccine boosters for everyone 5 years of age and older.
Anticipated Use: Pending CDC recommendations, it is expected that Pfizer will receive approval for its bivalent vaccine booster for children 5-11 years of age, and that Moderna will receive approval for its bivalent vaccine booster for children and adolescents 6-17 years of age.
Pending Food and Drug Administration (FDA) action, it is also expected that the Pfizer COVID-19 monovalent (orange cap) vaccine will be removed from emergency use authorization as a single booster for children 5-11 years of age.
If this occurs, it will mean that the COVID-19 monovalent vaccines are no longer authorized as booster doses for any age group. The monovalent vaccines will continue to be authorized for use as primary series vaccines for individuals 6 months of age and older. Please do not waste out your on-hand inventory, as access to primary vaccination remains critical.
Pfizer updated bivalent booster: Similar look to monovalent
The Pfizer bivalent vaccine will be used as the booster dose in children 5-11 years of age. The vaccine will be supplied in multiple-dose vials with an orange cap and orange vial border. The Pfizer monovalent COVID-19 vaccine will continue to be used for the primary series in children 5-11 years of age. This vaccine has an identical orange cap and orange vial border as the bivalent vaccine for this age group.
It is important to differentiate between the two vaccine products to ensure children 5-11 years of age receive the appropriate vaccine at the appropriate time. The Pfizer bivalent vaccine vial for use as a booster for children 5-11 years of age is labeled “Pfizer-BioNTech COVID-19 Vaccine, Bivalent Original and Omicron BA.4/BA.5.” The Pfizer monovalent vaccine vial for use as a primary series for children 5-11 years of age is labeled “Pfizer-BioNTech COVID-19 Vaccine.”
Moderna updated pediatric bivalent booster: Same bivalent product, different dose based on age
Vial Presentation: The same Moderna bivalent vaccine vial labeled “MODERNA COVID-19 VACCINE, BIVALENT” will be used for both children 6-11 years of age and people 12 years of age and older. Vaccine vials specifically labeled for the age group 6-11 years of age will not be available. This presentation of the Moderna COVID-19 vaccine is supplied as multiple-dose vials with dark blue caps with gray borders.
The bivalent dose volume (0.25mL) for children 6-11 years of age is one-half the dose volume (0.5mL) of the bivalent booster vaccine for people 12 years and older. So, there may be up to 10 doses per vial when using the vaccine for children 6-11 years of age, and up to 5 doses per vial when using the same vaccine for people 12 years and older. To account for the maximum number of potential doses per vial, orders indicated for children 6-11 years old will receive double the number of ancillary kits.
Ordering Requirement: Vaccinators must select in the COVID-19 Vaccine Ordering Survey which age group they intend to vaccinate, so that the appropriate number of ancillary kits can be sent. In the survey, the Moderna bivalent vaccine booster for children 6-11 years old will be listed as “Moderna 6Y-11Y Bivalent BOOSTER ONLY” and the Moderna bivalent vaccine booster for people 12 years and older will be listed as “Moderna 12Y+ Bivalent BOOSTER ONLY.”
Moderna 6Y-11Y Bivalent BOOSTER ONLY
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Moderna 12Y+ Bivalent BOOSTER ONLY
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SAME PRODUCT
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Dose: 0.25 mL with up to 10 doses/vial
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Dose: 0.5 mL with up to 5 doses/vial
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Will receive 2 times the ancillary kits to account for potential of more doses per vial
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Will receive standard ancillary kits
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Ordering timeline for the pediatric COVID-19 bivalent vaccine boosters
Vaccinators will be able to place orders for the pediatric COVID-19 bivalent boosters by the afternoon of October 6. Vaccinators may place pre-orders by completing the COVID-19 Vaccine Ordering Survey. No orders will be shipped until the FDA issues Emergency Use Authorizations (EUAs) for the pediatric bivalent boosters.
Administration of pediatric bivalent boosters can begin only after the CDC recommends them, and the CDC publishes its clinical considerations. Local Health Departments (LHDs) must wait until DHS updates the Immunization Program Policy and Procedure (P&P) Manual on SharePoint before providing any recommended vaccine boosters.
Note: It is expected that the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC Advisory Committee on Immunization Practices (ACIP) will not meet to discuss the authorization and recommendation of the COVID-19 bivalent boosters. So, the expectation is the FDA will authorize them, CDC will recommend them and CDC will publish its clinical considerations all within a short timeframe.
Attend the October 11 DHS webinar and Moderna and Pfizer training sessions
As vaccinators prepare and plan for the availability of the pediatric COVID-19 bivalent booster vaccines, DHS encourages them to attend the upcoming Wisconsin COVID-19 Vaccine Program Webinar. It will be held on Tuesday, October 11 from 11 a.m. – 12 p.m. These updates are held monthly, on the second Tuesday of each month.
Moderna is hosting two types of events, which cover the same topics regarding their vaccine. National Educational Webinars (25-minute presentation followed by live Q&A) and Interactive Office Hours (Several 5-minute presentations with emphasis on live Q&A).
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. To access dates and links for upcoming training sessions, please visit pfizermedicalinformation.com/medical-updates.
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