‌December 9, 2022 FDA Authorizes and CDC Recommends the Use of Infant/Toddler Bivalent Vaccines FDA authorized and the CDC recommended the use of the Moderna Bivalent Booster vaccine for infants and toddlers 6 months through 5 years and the Pfizer bivalent third dose vaccine for infants and to
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‌December 9,  2022

FDA Authorizes and CDC Recommends the Use of Infant/Toddler Bivalent Vaccines

 

FDA authorized and the CDC recommended the use of the Moderna Bivalent Booster vaccine for infants and toddlers 6 months through 5 years and the Pfizer bivalent third dose vaccine for infants and toddlers 6 months through 4 years.  


For those 6 months through 4 years, mixing brands is not authorized. 



Pfizer Bivalent Infant/Toddler

  • Eligibility: 
    • For those 6 months - 4 years that have received two doses of the Pfizer monovalent COVID-19 vaccine. 
    • Infants/toddlers who received three Pfizer monovalent doses will be considered as having completed their primary series and ineligible to receive an additional bivalent dose.
  • Vaccine Product Information:
    • Ultra-cold freezer storage (-90°C to -60°C) until expiry 
    • NO 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 
    • The minimum quantity for pre-orders is 100 doses 
    • Maroon cap identical to the monovalent Pfizer-BioNTech 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 Booster

  • Eligibility: 
    • For those 6 months - 5 years after 2 months of completing their primary series by receiving two doses of the Moderna monovalent COVID-19 vaccine or three doses for those who are immunocompromised. 
  • Vaccine Product Information:
    • NO ULTRA-COLD FREEZER STORAGE (-90°C to -60°C) 
    • 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). Please note, they are not single dose vials.  
    • Dose 10mcg/0.2mL 
    • The minimum quantity for pre-orders is 100 doses 
    • Vial with dark pink cap and yellow border on the label 
    • Once punctured, each vial must be used within 8 hours (Note that this is different than the 12 hour time limit for other Moderna products) 

Allocations and Ordering: 

  • Pre-orders will be delivered starting Monday, December 12 through Friday, December 16. 
  • Orders placed after 5PM on December 2nd will be delivered starting Wednesday, December 14 through Friday, December 16. 


Monovalent Pfizer Vaccine 

  • The monovalent Pfizer COVID-19 Vaccine is no longer authorized for use as the third dose of the three-dose primary series in children 6 months - 4 years of age. 
  • It remains authorized for administration for the following: 
    • As the first two doses of the three-dose primary series in individuals 6 months through 4 years of age 
    • As a two-dose primary series for individuals 5 years of age and older 
    • As a third primary series dose for individuals 5 years of age and older who are immunocompromised. 

Resources: 

  • FDA Press Release
  • CDC Press Release
  • Interim Clinical Considerations for the Use of COVID-19 Vaccines
  • Pfizer Medical Updates and Immunization Site Trainings
  • CDC Child Age Transition Guide
  • Provider FAQs
  • CDC COCA Call on Bivalent Vaccines
  • COVID-19 Vaccine Product Guide


 

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‌COVID19 Vaccination Program

‌‌California Department of Public Health | Immunization Branch
850 Marina Bay Pkwy
Richmond CA 94804

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