Pfizer and Moderna Pediatric Bivalent Vaccine Prebooking Update

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Dear Immunization Partners,

Please review the following COVID-19 vaccine update on Pfizer and Moderna COVID-19 pediatric bivalent vaccine.

PEDIATRIC BIVALENT COVID-19 VACCINE UPDATE

• If authorized by FDA, 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.

PEDIATRIC BIVALENT COVID-19 VACCINE ORDERING GUIDANCE

• Bivalent Pfizer vaccine for children aged 6 months through 4 years and bivalent Moderna vaccine for children 6 months through 5 years will each be a new product with a unique National Drug Code (NDC). Prior to a potential EUA, there will be a single pre-ordering period expected to begin at 10:00 a.m. ET on November 28, 2022, and to end on or about December 6, 2022, at 9:00 a.m. ET. Pre-ordering enables bivalent COVID-19 vaccines to be shipped immediately following EUA. Changes in this schedule are possible, so continue to monitor instructions from MDHHS in case the order window is changed.
• Doses that are pre-ordered will begin being processed for delivery following EUA. Expected delivery schedules will be dependent on the actual EUA date.

PFIZER BIVALENT COVID-19 VACCINE 6 MONTHS THROUGH 4 YEARS

• Expected characteristics of Pfizer bivalent COVID-19 vaccine for children aged 6 months through 4 years:
  • Ultra-cold freezer storage (-90°C to -60°C) until expiry
  • NO Standard FREEZER STORAGE (-25°C to -15°C)
  • Refrigerate (2°C to 8°C) up to 10 weeks without puncturing
  • Requires 2.2 mL diluent per vial (providers will NOT be able to opt out of receiving ancillary kits)
  • Packaged in 10-dose vials in cartons of 10 vials each (100 doses total)
  • Dose 3mcg/0.2mL
  • Minimum order quantity of 100 doses
  • Maroon cap identical to the monovalent Pfizer product for this age group
  • New label identifying the product as a bivalent vaccine (i.e., Original and Omicron BA.4/BA.5)
  • Once punctured, each vial must be used within 12 hours

 

MODERNA BIVALENT COVID-19 VACCINE 6 MONTHS THROUGH 5 YEARS

• Expected characteristics of Moderna bivalent COVID-19 vaccine for children aged 6 months through 5 years:
  • NO ULTRA-COLD FREEZER STORAGE (-90°C to -60°C)
  • Standard Freezer storage (-50°C to -15°C) until expiry
  • Refrigerate (2°C to 8°C) up to 30 days without puncturing
  • Does not require diluent (providers will be able to opt out of receiving ancillary kits)
  • Packaged in 2-dose vials in cartons of 10 vials each (20 doses total)
  • Dose 10mcg/0.2mL
  • Minimum order quantity of 100 doses
  • Vial with dark pink cap and yellow border on the label
  • Once punctured, each vial must be used within 8 hours

ANCILLARY KITS

• Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes. An ancillary opt-out continues to be available for all non-diluent kits and would be available for Moderna bivalent COVID-19 vaccine for children aged 6 months through 5 years.
• Pfizer bivalent COVID-19 vaccine for children aged 6 months through 4 years is expected to require diluent, so providers would NOT be able to opt out of receiving ancillary kits.

Additional information on ordering is available on our COVID-19 Provider Guidance website’s Orders & Shipments page. Please be proactive in your vaccine planning needs.

If you have questions, please contact checcimms@michigan.gov.

Thank you,
MDHHS Division of Immunization