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Minnesota Department of Health
March 4, 2021
Good afternoon,
Here are the COVID-19 vaccine provider updates for 2/26 to 3/4.
The provider guide has been updated at COVID-19 Vaccine Providers:
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Main guide: In the “COVID-19 vaccine products” section, a statement was added that there is no product preference with the COVID-19 vaccines. This means no vaccine is preferred for any specific population or group for the first dose. Appendix C link is added on Page 7. Reference to Johnson & Johnson’s Janssen COVID-19 vaccine added on Page 8, 13, and 19.
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Appendix A/Pfizer-BioNTech COVID-19 vaccine (renamed): Updated Pfizer vaccine summary chart adding new freezer storage up to two weeks (14 days) and revised footnotes (Page 1; some content moved to Page 11). New option (#4) in “storage and handling” for storing Pfizer vaccine in the freezer (Page 4). New section titled “temperature monitoring and documentation” added (Page 4-5).
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Appendix B/Moderna COVID-19 vaccine (renamed): New section titled “temperature monitoring and documentation” added (Page 3).
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New! Appendix C/Janssen COVID-19 vaccine (renamed): New information on Janssen vaccine.
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Appendix D: Link to the new Transporting COVID-19 Vaccines (PDF). Preparing COVID-19 Vaccines for Administration (PDF) and COVID-19 Vaccine: Redistribution and Off-site Vaccination Guide (PDF) have been modified to accommodate for this new transport resource.
Module 5 is now available at COVID-19 Vaccine Trainings for Health Professionals. This training is required for vaccine coordinators and back-up coordinators and strongly recommended for anyone who is handling or administering the Janssen vaccine. Links to resources about the Janssen vaccine are listed below Module 5: Janssen COVID-19 vaccine on the webpage.
For sites receiving Janssen vaccine, the vaccine coordinator and back-up coordinator will be required to attest that they read the material in the guide and viewed the training.
Late on March 3, CDC changed the former interim clinical consideration webpage for mRNA vaccines to Interim Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. We will be updating our Interim COVID-19 Vaccine Provider Guide. Highlights of recent changes to CDC’s clinical considerations include:
- Clinical considerations added for use of Janssen COVID-19 vaccine.
- Updated recommendations for fully vaccinated people who subsequently develop COVID-19.
- Updated recommendations related to COVID-19 vaccination timing for immunocompromised people.
- Updated contraindications and precautions for mRNA COVID-19 vaccines.
- Updated information on interpretation of SARS-CoV-2 antibody test results after vaccination.
New guidance on moving, monitoring, and packing COVID-19 vaccines has been posted at COVID-19 Vaccine Providers and in Appendix D: Vaccination at Satellite, Temporary, or Off-site Locations (PDF) of the provider guide as part of the off-site vaccination package.
Janssen COVID-19 vaccine is initially stored frozen by the manufacturer, then shipped at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit). If vaccine is still frozen when it arrives, place it in the refrigerator at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) to thaw. If you need it immediately, thaw the vaccine at room temperature (maximum 25 degrees Celsius/77 degrees Fahrenheit). A carton of ten vials will take about two hours to thaw; an individual vial will take about one hour. Do not refreeze vaccine once thawed. Do not return the shipping container.
The new COVID-19 Janssen vaccine protocol template will be posted soon at COVID-19 Vaccine Providers and Vaccine Protocols.
The FDA did not translate the emergency use authorization (EUA) fact sheets into all the common languages spoken in Minnesota, so we translated the fact sheets in six additional languages. Find them at COVID-19 Vaccine Providers. We plan to translate the Janssen EUA fact sheet as well.
On Feb. 25, 2021, the U.S. Food and Drug Administration (FDA) announced that it is allowing undiluted frozen vials of Pfizer-BioNTech COVID-19 vaccine to be stored at conventional pharmaceutical freezer temperatures (-25 to -15 degrees Celsius or -13 to 5 degrees Fahrenheit) for up to 14 days. Vials must be kept frozen and protected from light until ready to use.
Vials stored in the freezer at -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit) for up to 14 days may be returned one time to the recommended ultracold storage condition of -80 to -60 degrees Celsius (-112 to -76 degrees Fahrenheit). This includes vials that are held up to 14 days at -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit), and in risk of not being used in time.
Total cumulative time the vials are stored at -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit) should be tracked and should not exceed two weeks. CDC is updating Pfizer beyond-use date labels to track this 14-day timeframe and they will be available at CDC: Pfizer-BioNTech COVID-19 Vaccine.
These changes are further outlined in FDA: Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF).
Check the expiration date before preparing or administering vaccine. Expired vaccine or diluent should never be used. As additional stability data become available, the expiration dates for some products may change. CDC’s COVID-19 Vaccine Expiration Date Tracking Tool (PDF) can help providers keep track of the expiration date by lot number.
For Moderna and Janssen vaccine, when the vaccine nears its expiration date, check the QR code or manufacturer website again to see if the lot number for the vaccine you are storing has been extended. It may have a new beyond-use date.
Janssen COVID-19 vaccine
The expiration date is not printed on the vaccine vial or carton. To determine the expiration date, do one of these three things:
Moderna COVID-19 vaccine
The expiration date is not printed on the vaccine vial or carton. To determine the expiration date, do one of these two things:
Pfizer COVID-19 vaccine
This vaccine product has an expiration date located on the vaccine vial. CDC will be updating VTrckS effective immediately to replace the placeholder date in VTrckS with the actual expiration date.
COVID-19 vaccine order cancellations can be requested only by awardee and federal agency/pharmacy points of contact. Providers and administration sites cannot request cancellations. If you have any questions about your COVID-19 vaccine shipment, please contact us at health.mdhvaccine@state.mn.us. Do not contact the manufacturer directly.
Registered COVID-19 providers can report vaccine wastage in MIIC. Refer to Reporting Nonviable COVID-19 Vaccine to MIIC (PDF) for guidance.
Please disregard any email you may get about shipping labels or expired or spoiled COVID-19 vials. COVID-19 vaccine doses are not being returned to the manufacturer or McKesson. Dispose of vials per recommendations found in the COVID-19 vaccine provider guide.
Race and ethnicity data are very important for knowing who we are vaccinating and to uphold health equity in our pandemic response.
To that end, MDH is now requiring providers to submit available race/ethnicity information into MIIC as part of their regular reporting for all patients who are getting vaccinated.
As with all our data, we take data privacy very seriously and will only use this information to help us see who is getting vaccinated in Minnesota. These data will also help us identify and address health equity-related gaps in our vaccine distribution plans.
To verify if this information is included in your messages to MIIC, you may need to consult with your IT team or EHR vendor. If you are collecting race/ethnicity data, but your system is not currently sending it to us, please reach out to the MIIC help desk (health.miichelp@state.mn.us) so that we can help you add this data to your messages without negatively impacting the processing of your messages. If you do not have an electronic interface with MIIC, we are working to update our immunization spreadsheet to include space for race and ethnicity information.
The Minnesota Immunization Information Connection (MIIC) is conducting a four-part webinar series. The final webinar is next Tuesday, March 9, from 11:30 a.m. to 12:30 p.m.
The MIIC team will be holding office hours. Please send your MIIC-related questions before the office hours. We will review and ensure that we can answer those questions during the Tuesday webinar. Please submit your questions to: health.miichelp@state.mn.us, with the subject line: “Questions for MIIC office hours.” We will also take questions the day of the office hours. Click here to join the March 9 Microsoft Teams Live Event.
Recordings for webinars #1 and #2 are posted at MIIC User Guidance and Training Resources. The third webinar’s recording will be available soon.
We are hosting office hours for health care providers. The office hours happen twice a week on Tuesdays at 12:30 p.m., and Fridays at 8 a.m. They last for 30 minutes.
This is time for you to come and ask questions of the vaccine clinical experts at MDH. Feel free to drop in at any point during the half-hour time slot.
Tuesdays at 12:30 p.m.: Click here to join the Teams meeting. Join on your computer or mobile app.
Fridays at 8 a.m.: Click here to join the Teams meeting. Join on your computer or mobile app.
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