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 ice Storage: Ultra-cold – until manufacture expiration date Fridge – 10 weeks Doses per vial: 6 Cap color: Grey Minimum Order Quantity: 300 doses (5 boxes) Moderna Bivalent Booster Age: 18+ – pending Ships: Frozen Storage: Frozen – until manufacture expiration date Fridge – 30 days Doses per vial: 5 Cap color: Blue Minimum Order Quantity: 100 doses (2 boxes)