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Minnesota Department of Health
September 2, 2021
Good afternoon,
Here are the COVID-19 vaccine provider updates for Aug. 27 to Sept. 2, 2021.
Booster doses are currently not recommended.
Giving booster doses without FDA authorization and ACIP recommendation are a violation of your provider agreement and may put you at risk of no longer being able to provide vaccine.
Continue your current focus to get unvaccinated patients vaccinated and complete vaccination series in partially vaccinated people. This focus has the greatest impact on reducing the spread of COVID-19 and its more severe outcomes. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated.
The U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) on Aug. 23, 2021, for prevention of COVID-19 disease in people age 16 years and older. The Advisory Committee on Immunization Practices (ACIP) voted on Aug. 31, 2021, to recommend Comirnaty in people age 16 and older. This mRNA vaccine continues to be available for people age 12-15 under emergency use authorization (EUA). Read more in news releases at FDA Approves First COVID-19 Vaccine and CDC Media Statement: CDC Statement Following ACIP Pfizer-BioNTech Vote.
COVID-19 vaccine providers should continue to vaccinate and use Pfizer’s COVID-19 vaccine as you have been. The full license does not impact current recommendations or supply chain; the vaccine will continue to be provided at no cost through the government contracts.
While we wait for a vaccine to be authorized in children younger than age 12, it is important that everyone who is eligible now get the vaccine. The Delta variant has led to significant increases in the number of children and adults infected with COVID-19. Vaccination of eligible groups will help reduce the spread of the virus and protect those who are too young to be vaccinated.
Off-label use
Off-label actions (such as administering the vaccine to children age 11 years and younger) are a violation of section 1 of the COVID-19 Vaccination Program Provider Agreement. As a reminder, providers are responsible for adhering to all requirements outlined in the agreement. Specifically, providers must administer COVID-19 vaccines in accordance with all CDC COVID-19 vaccination program provider requirements. This applies to both EUA and FDA-licensed COVID-19 vaccines. Use of these products outside of licensure specifics that have been put forth by FDA (off-label use) could expose providers to the following risks:
- 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.
- People 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 U.S. government 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.
The American Academic of Pediatrics strongly discourages providers from administering the vaccine off-label for children age 11 and younger. Clinical trials are underway for this age group and more data will hopefully be available soon. Read more at Read more at COVID-19 Vaccine FAQs for Healthcare Professionals: Off-label use and American Academy of Pediatrics Cautions Against Off-Label Use of COVID-19 Vaccines in Children Under 12.
On August 31, 2021, CDC updated the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States with new recommendations about COVID-19 vaccination and the timing of immune-based tests for tuberculosis infection, such as the TST and IGRA.
MDH guidance has always reflected the new CDC language: COVID-19 vaccination should not be delayed because of testing for TB infection. The change to the detail of timing is as follows: testing for TB infection with one of the immune-based methods, either the tuberculin skin test (TST) or an interferon release assay (IGRA) (refer to CDC: Testing for TB Infection), can be done before, after, or during the same encounter as COVID-19 vaccination.
MDH will update our website and provider guide to remove guidance documents that are no longer relevant.
Due to the federal holiday, there will be no Pfizer deliveries on Monday, September 6, and there will be no Moderna deliveries on Monday, September 6 and Tuesday, September 7.
The Pfizer delivery cadence is changing. Providers can now expect Pfizer vaccine deliveries within three to five days of placing their orders in MIIC. Providers who order Moderna can still expect their vaccine deliveries within two to three days of placing their orders in MIIC.
Refer to our user guide for step-by-step instructions on how to order COVID-19 vaccine in MIIC: Special Event Vaccine Request (PDF).
The FDA approved an amendment to the EUA for Pfizer-BioNTech COVID-19 vaccine, extending the expiration dates from six to nine months. Cartons and vials with an expiration date of August 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date, as long as authorized ultracold storage conditions between -90 to -60 degrees Celsius (-130 to -76 degrees Fahrenheit) have been maintained.
Please note: Frozen vials stored at -25 to -15 degrees Celsius and refrigerated vials (2 to 8 degrees Celsius) are not eligible for extension.
Refer to the table below regarding expiry dates for vaccine maintained in ultra-cold storage.
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Printed expiry date
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Updated expiry date
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June 2021
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September 2021
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July 2021
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October 2021
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August 2021
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November 2021
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September 2021
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December 2021
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October 2021
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January 2022
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November 2021
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February 2022
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December 2021
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March 2022
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January 2022
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April 2022
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February 2022
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May 2022
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To prevent vaccine from inadvertently being discarded, make sure to verify dates and label the trays with the correct beyond-use date (BUD).
Additional information on Pfizer storage and handling may be found at: CDC: Pfizer-BioNTech COVID-19 Vaccine.
BUD case scenarios
With the Pfizer-BioNTech COVID-19 vaccine expiration date extension, we have included a few case scenarios you might encounter.
Case scenario #1: You move a vial of Pfizer vaccine from freezer storage to the refrigerator on August 15. It is marked with the expiration date of August 2021 (August 31, 2021). Can you store this vaccine for the full 31 days allowed for refrigeration storage, or do you need to administer it by August 31, 2021?
Yes, you can store this vaccine vial for the full 31 days (i.e., through September 15, 2021). The recent expiration date extension changes the expiration date to November 2021. The BUD replaces the manufacturer’s expiration date (now November/2021) and should be noted on the label along with the initials of the person making the calculation.
Case scenario #2: You move a vial of Pfizer vaccine from ultracold storage to the freezer on August 23. It is marked with the expiration date of August 2021 (August 31, 2021). Can you store this vaccine for the full 2 weeks allowed in the freezer? After that time, can you still move it to the refrigerator and store for an additional 31 days?
Yes, you can store this vaccine vial for the full 2 weeks in the freezer (through September 6, 2021), move it to the refrigerator, and store for an additional 31 days (October 7, 2021). The recent expiration date extension changes the expiration date to November 2021. The BUD replaces the manufacturer’s expiration date (now November 2021) and should be noted on the label along with the initials of the person making the calculation.
Case scenario #3: You move a vial of Pfizer-BioNTech COVID-19 vaccine from the freezer to the refrigerator on August 1, 2021. Since the expiration date has been extended, can you store this vial in the refrigerator through November 30, 2021?
No, you cannot store this vial through the extended expiration date. A vial can be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month (31 days) regardless of the expiration date extension.
Clinical guidance and resources for storing, preparing and administering the vaccine, including labels to assist with tracking the BUD can be found at CDC: Pfizer-BioNTech COVID-19 Vaccine.
Pfizer will again be hosting training sessions to review information and answer questions about the Pfizer-BioNTech COVID-19 vaccine.
Please click on the links below to join the sessions at the designated times. Each training below is the same content.
We have been working with a number of COVID-19 vaccine providers at their invitation to use MIIC functionality to send text messages to their patients in need of doses to complete their series. The program can be geared towards immunocompromised patients in need of a third dose, those who have missed a second COVID-19 vaccine dose, or other criteria as recommended by your organization. Texts can be sent leading up to the recommended timeframe for a client, and/or after a client has missed their vaccine dose.
MDH is currently working with 12 organizations including six local public health entities and six health providers. To date, over 100,000 text messages have been sent to clients who were overdue for their second dose of COVID-19 vaccine, 30% of whom went on to complete the series. The MIIC team is working on partnering with providers who serve high numbers or percentages of clients who live in high Social Vulnerability Index (SVI) ZIP codes.
This texting program does not require a lot of work on the part of the participating provider. If you are interested in partnering or would like some more information, please contact the MIIC Help Desk.
A reminder that it is possible to run a report in MIIC to assess and monitor COVID-19 immunization coverage rates over time for your organization. Please review our user guide and training video at Immunization Assessment.
MIIC also has a feature to generate lists of clients overdue or recommended for vaccine. Please find the user guidance at Client Follow-up.
Please contact the MIIC Help Desk with any questions you have!
On Aug. 25, 2021, CDC updated the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States to include information on people vaccinated for COVID-19 as part of a clinical trial in the United States. This new language specifies which clinical trial participants can be considered fully vaccinated for public health purposes, and who might need additional doses.
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