On August 23 the FDA approved an amendment to the EUA for Pfizer-BioNTech extending the expiration dates of COVID-19 Vaccine from six to nine months FOR VACCINE KEPT IN ULTRA-COLD STORAGE ONLY.
Cartons and vials of Pfizer-BioNTech’s Comirnaty vaccine may remain in use for 3 months beyond the printed date as long as authorized storage conditions (-90°C to -60°C or -130°F to -76°F) have been maintained.
Frozen vials stored at -25°C to -15°C and refrigerated vials stored at 2°C to 8°C are NOT eligible for extension.
A majority of our providers do not have ultra-cold storage units, so this guidance would not apply to them if they are storing their vaccine in a regular freezer or refrigerator.
The extension ONLY applies to vaccine that has been stored in ultra-cold storage.
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As with the other COVID-19 vaccine manufacturers, we are anticipating that Moderna will also be submitting data for a shelf life extension on some lots of vaccine. As soon as we learn more details, we will communicate the lot numbers that will be subject to the extension. As of right now, we do not know when this will occur.
In the meantime, please quarantine any expired Moderna vaccine until further guidance.
 The U.S. FDA has granted full approval to Pfizer’s COVID-19 vaccine. Full approval has been given for people 16 years of age and older. Pfizer’s shot still has emergency authorization for 12 to 15-year-olds. For more information, please visit the FDA's News Release. |
On September 1, the Maine Immunization Program opened up ordering for influenza vaccines in ImmPact for VFC enrolled providers.
Available influenza vaccines include:
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FluLaval Quad
- NDC #: 19515-0818-52
- Children 6 months or older
- 0.5mL prefilled syringe
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Fluzone Quad
- NDC #: 49281-0421-50
- Children 6 months or older
- 0.5mL prefilled syringe
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FluMist Quad
- NDC #: 66019-0308-10
- Children 6 months or older
- Nasal Sprayer
Note: We will not be offering adult influenza vaccine this year.
For more information on the ordering process, please refer to the original communication sent to providers on August 27.
Pfizer COVID-19 vaccine orders in ImmPact have changed from the minimum order quantity of
450 doses, to the minimum order quantity of 1,170 doses. The 450-dose option is no longer
available.
The new NDC will be 59267-1000-02.
Moderna orders will remain the same.
In an effort to clear up any confusion among providers about whether or not they can offer booster doses of COVID-19 vaccine at the present time, the Maine Immunization Program would like to remind COVID-19 providers of the following key elements:
- Administration of the product off-label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims.
- Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
- CDC has defined the scope of the CDC COVID-19 Vaccination Program in terms of how the USG-provided vaccines may be used in the program. Providers giving off-label doses would be in violation of the CDC Program provider agreement potentially impacting their ability to remain a provider in the CDC program.
- Administration fees may not be reimbursable by payers.
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