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Bivalent Pfizer and Moderna Boosters Are Coming

Bivalent Pfizer and Moderna Boosters Are Coming

On June 30, 2022, the U.S. Food and Drug Administration (FDA) advised manufacturers seeking to update their COVID-19 vaccines to add an Omicron BA.4/5 spike protein component to the current vaccine composition to create a bivalent booster vaccine. Pending potential FDA Emergency Use Authorizations (EUAs) for new bivalent COVID-19 boosters developed by Pfizer-BioNTech and Moderna in or around September 2022, CDC’s Advisory Committee on Immunization Practices (ACIP) will convene to discuss potential recommendations. Administration of any new bivalent COVID-19 boosters can begin only after CDC’s official recommendations.What We Know So Far:
  • Pre-ordering for both Pfizer and Moderna bivalent boosters will begin on Monday, August 22, 2022, and close Wednesday, August 24, 2022, at 5pm.
    • Sites should plan to manage necessary freezer/refrigerator space as well as inventory/ordering to avoid waste when developing their overall fall vaccine plans.
  • These bivalent formulas can only be used for boosters for individuals who have completed their primary series.
  • Bivalent boosters will include a BA.4/5 valence specifically.
  • The original Pfizer and Moderna vaccine formulas should only be used for primary series vaccinations once the bivalent products arrive.
    • As the cap colors/borders will be the same for bivalent boosters and the original formulas, sites will need to be mindful of packaging/labeling to differentiate the two products.
  • Delivery will begin after Labor Day – date TBD.
  • ACIP will meet to make official recommendations about vaccine intervals and dosing schedules.
  • EUAs for these two bivalent products are not yet available.
  • It is expected that at least one bivalent vaccine for children ages 11 years and younger may be authorized within a short time following the authorization(s) of bivalent vaccines for people ages 12 years and older.
Pfizer Bivalent Booster
Age: 12+ – pendingShips: Ultra-cold on dry iceStorage: Ultra-cold – until manufacture expiration date             Fridge – 10 weeksDoses per vial: 6Cap color: GreyMinimum Order Quantity: 300 doses (5 boxes)Moderna Bivalent BoosterAge: 18+ – pendingShips: FrozenStorage: Frozen – until manufacture expiration date             Fridge – 30 daysDoses per vial: 5Cap color: BlueMinimum Order Quantity: 100 doses (2 boxes)