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Bivalent Pfizer and Moderna Boosters Are Coming

18 Aug Bivalent Pfizer and Moderna Boosters Are Coming

Posted at 12:32h in COVID-19 by

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)