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Greetings,
On June 28, 2022, FDA’s independent experts on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons. The advisory committee voted in favor of including a SARS-CoV-2 Omicron component in COVID-19 vaccines that would be used for boosters in the United States beginning in fall 2022. FDA subsequently clarified intent to authorize bivalent boosters including a BA.4/5 valence specifically.
The bivalent COVID-19 vaccine will be administered as a single booster dose to those who previously completed a primary series of COVID-19 vaccine. It is anticipated that bivalent COVID-19 vaccine booster doses may initially be authorized for people ages 12 years and older (Pfizer-BioNTech) and for people ages 18 years and older (Moderna), followed by younger pediatric age groups. It is also anticipated that the bivalent COVID-19 vaccines will only be authorized as a single dose in people who have completed any COVID-19 primary vaccination series but would not vary by number or type of prior booster doses received.
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Pfizer-BioNTech Storage and Handling
- Ultra-cold freezer storage (-90°C to -60°C) until expiry
- NO FREEZER STORAGE
- Refrigerate (2°C to 8°C) up to 10 weeks without puncturing
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Moderna Storage and Handling
- Freezer storage (-25°C to -15°C) until expiry
- NO ULTRA-COLD FREEZER STORAGE
- Refrigerate (2°C to 8°C) up to 30 days without puncturing
Packaging Information
Pfizer-BioNTech bivalent COVID-19 vaccine is expected to be packaged in 6-dose vials in cartons of 10 vials each (60 doses total), with a minimum order quantity of 300 doses. Moderna bivalent vaccine will be packaged in 5-dose vials in cartons of 10 vials each (50 doses total), with a minimum order quantity of 100 doses. Once punctured, each vial must be used within 12 hours. Similar to existing Moderna and Pfizer-BioNTech (gray cap) products, vials must be discarded ≤12 hours after the first puncture. 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.
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Potential Bivalent COVID-19 Vaccine Product Details*
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Manufacturer/Vial
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Vaccine Age Range
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Vaccine Dosing
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Storage/Other Details
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Pfizer-BioNTech
6 doses per vial
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12 years and Older
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0.3mL
NO diluent required
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Ships at -80°C
For details, see Pfizer-BioNTech COVID-19 Vaccine Products
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Moderna
5 doses per vial
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18 Years and Older
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0.5mL
NO diluent required
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Ships at -20°C
A document with details on this vaccine is being developed
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*Subject to change pending submission of applications, emergency use authorization(s), and CDC recommendation(s).
Doses pre-ordered will be made available immediately following EUA.
Pre-orders will occur in two waves —
- Wave 1
- Wave 1 pre-ordering will start August 18 at 10:00 AM CST and will end August 22 at 5:00 PM CST.
- Wave 2
- Wave 2 pre-ordering will start August 22 at 6:00 PM CST and end August 29 at 5:00 PM CST.
Please see the following helpful resources:
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