IMPORTANT UPDATE: COVID-19 bivalent mRNA vaccine boosters recommended for children as young as 6 months

To All Enrolled COVID-19 Vaccine Providers,

Bivalent mRNA COVID-19 vaccines created to strengthen protection against the original COVID-19 strain and the currently circulating Omicron variant can now be administered to children as young as age 6 months when vaccine supply is available at your location.

The U.S. Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) for COVID-19 bivalent vaccines made by Pfizer-BioNTech (6 months through 4 years) for use as the third dose in the primary series and Moderna (6 months through 5 years) for use as a booster dose. In addition, the Centers for Disease Control and Prevention (CDC) expanded its recommendations to include the use of updated (bivalent) COVID-19 vaccines for children down to age 6 months.

  • Children ages 6 months through 4 years who are currently completing a Pfizer primary series will receive a Pfizer-BioNTech COVID-19 bivalent vaccine for their third dose of the primary series. Children in this age group who completed their 3-dose monovalent Pfizer-BioNTech COVID-19 primary series are not eligible for the bivalent product at this time.
  • Children ages 6 months through 5 years who previously completed a Moderna primary series are eligible to receive a Moderna bivalent booster 2 months after their final primary series dose.

Here are more product-specific details:

PFIZER-BIONTECH

The Pfizer-BioNTech COVID-19 bivalent vaccine is authorized ONLY as a third dose in the primary series for children ages 6 months through 4 years. 

  • Doses 1-2: Give maroon cap Pfizermonovalent  The second dose should be given 3 weeks after the first dose.
  • Dose 3: Give maroon cap Pfizerbivalent vaccine at least 8 weeks after the second dose to complete the primary series.
  • It’s important to differentiate between the two vaccine products for this age group to ensure individuals receive the appropriate vaccine for each dose.The maroon caps and maroon vial label borders are identical. Look for the word “bivalent” on the vial label and carton (i.e., Original and Omicron BA.4/BA.5) to distinguish.
  • Dose 3mcg/0.2mL, IM
  • Requires diluent: 2.2mL preservative free Sodium Chloride injectable 0.9% supplied within the ancillary kit
  • Packaged in 10-dose vials in cartons of 10 vials each (100 doses total)
  • Minimum order quantity of 100 doses
  • Storage is consistent with Pfizer-BioNTech COVID-19 vaccines:
    • ULT-Freezer until expiry (-90 degrees Celsius to -60 degrees Celsius)
    • Refrigerator (2 degrees C to 8 degrees C) for up to 10 weeks without puncturing
    • Room temperature (8 degrees C and 25 degrees C)
      • 12 hours before first puncture
      • 12 hours after the first puncture and discard any remaining vaccine and vial once the Beyond-Use Date (BUD) time has been met.
    • Do NOT store in regular freezer.
    • Do not refreeze.
    • Do not pool vials.
  • Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes. Ancillary kitopt-out is not an option for this vaccine as it requires diluent.

MODERNA

The Moderna COVID-19 bivalent vaccine booster can be given to people ages 6 months through 5 years if it’s been at least two months since completion of the primary series.

  • The vaccine is in a dark pink capped vial with a yellow banded label with the words “BOOSTER DOSE ONLY” on the band. The cartons also have a yellow border.
  • The vaccine comes in a multidose vial containing two doses.Providers should NOT administer the whole vial. These are not packaged as single doses.
  • The dosage/injection volume for each booster dose is10mcg/0.2 mL.
  • Storage is consistent with Moderna COVID-19 vaccines:
  • NO ULTRA-COLD FREEZER STORAGE (-90°C to -60°C)
    • Freezer: -50º C and -15º C (-58º F and 5º F)until the expiration date.
    • Refrigerator: 2º C and 8º C (36º F and 46º F)for up to 30 days prior to the first use.
    • Room Temperature: 8º C and 25º C (46º F and 77º F) Cumulative up to 24 hours.
    • Discard remaining dose8 hours after first puncture.
  • Do NOT pool vials to obtain additional doses.
  • Does not require diluent (providers will be able to opt out of receiving ancillary kits)
  • Minimum order quantity of 100 doses
  • Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes. Ancillarykit opt-out is an option for this vaccine.  Just type in “no-ancillary kits” in comments section of order.

PREORDERED VACCINE

Deliveries of pre-ordered vaccine are expected to begin arriving Monday, Dec. 12, or Tuesday, Dec. 13. For those providers who did not pre-order, ordering details are included below.

ORDERING

The Ohio Department of Health is accepting orders now for the Pfizer-BioNTech and Moderna COVID-19 bivalent vaccines through VOMS.

  • VOMS is open for providers to place orders 24 hours a day, 7 days a week.
  • The minimum order quantity will be100 doses. Providers may choose either the Pfizer or the Moderna vaccines for young children.
  • Orders can be placed using the existingCOVID-19 – Pfizer and COVID-19 Moderna order sets. The new formulation of each vaccine will be one of the product options available within the order set. Providers must enter the total quantity requested in the “Doses Requested” field in multiples of 100.
  • The ability to administer within 12 hours once a vial is opened (or within 8 hours for a vial of the Moderna COVID-19 bivalent vaccine for children aged 6 months through 5 years) should be a planning consideration.
  • A “soft-cap” maximum of 300 doses will be placed on each order at this time to help with the equitable distribution of the vaccine. Please order only what you plan to use in the near future. If you have a special request for a local vaccination effort that would require more doses, please call the ODH Provider Call Center at 1-844-9ODHVAX (1-844-963-4829) and we will work with you.
  • These age groupsshould receive all doses from the same vaccine manufacturerMix-and-match use is not authorized for this age group.
  • Provider locations should manage inventory to ensure availability of primary series doses, in addition to bivalent vaccine doses.

RESOURCES FOR PROVIDERS:

The Ohio Department of Health is reviewing updated CDC clinical guidance for COVID-19 vaccines, including administration of booster doses, and will share updated resources for Ohio providers after reviewing that guidance. ODH will reschedule its regular COVID-19 vaccine provider training webinar next week in order to incorporate new information and resources for these new pediatric bivalent products. Details are forthcoming.

The Ohio Department of Health COVID-19 Provider website is a hub for a variety of resources for vaccine providers. Vaccine providers with questions may call the ODH Provider Call Center at 1-844-9ODHVAX (1-844-963-4829) between 8 a.m. and 5:30 p.m. Mondays through Fridays or email COVIDVACCINE@odh.ohio.gov.

Sincerely,
Ohio COVID-19 Vaccine Provider Relations Team

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