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Minnesota Department of Health
April 8, 2021
Good afternoon,
Here are the COVID-19 vaccine provider updates for 4/2-4/8.
On April 1, the FDA updated the Moderna vaccine Emergency Use Authorization (EUA): Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available.
Updates to EUA fact sheets
FDA: Moderna COVID-19 Vaccine EUA Fact Sheet for Health Care Providers (PDF) revised March 31, 2021:
- Dose per vial
- 10-dose vial; now have permission to use an 11th dose if you can draw a whole 0.5 mL dose.
- Updating to larger vials; maximum 15-dose vial presentation with a range of 13-15 doses. These will probably be available starting the beginning of May, more details to come.
- Updated storage and handling
- Lower limit for frozen temperature, now -50 degrees Celsius (previously -25 degrees Celsius). These are the normal frozen vaccine temperatures.
- Unpunctured vials may be stored between 8 and 25 degrees Celsius for a total of 24 hours (was 12 hours previously).
- After puncture, the vial should be held between 2 and 25 degrees Celsius; discard 12 hours after the first puncture (was 6 hours previously).
- Updated adverse reactions
- Added that severe adverse reactions, including anaphylaxis, have been reported during mass vaccination outside of clinical trials.
- Added that delayed injection site reactions that began more than seven days after vaccination were reported in 1.2% of vaccine recipients and 0.4% of placebo recipients. Delayed injection site reactions included pain, erythema, and swelling and are likely related to vaccination.
FDA: Moderna COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers (PDF) revised March 26, 2021:
- Added severe allergic reactions to the risks.
- Added two new sections entitled “Can I be charged an administration fee for receipt of the COVID-19 vaccine?” and “Where can I report cases of suspected fraud?”
Appendix B: Moderna COVID-19 vaccine of the provider guide has been updated at COVID-19 Vaccine Providers this week based on the FDA’s recent EUA changes.
Patients may have questions regarding COVID-19 vaccination and when it is okay to have a mammogram. Regardless of vaccination status, people should contact their health care provider right away if they have breast symptoms (e.g., breast pain, lump, or other changes).
Use these talking points if you receive questions:
- If you were recently vaccinated for COVID-19 and are due for a mammogram, ask your doctor if you should wait to get your mammogram.
- People who have received a COVID-19 vaccine can have swelling in the lymph nodes (lymphadenopathy) in the underarm near where they got the shot.
- This swelling is a normal sign that your body is building protection against COVID-19. However, it is possible that this swelling could cause a false reading on a mammogram.
- Some experts recommend getting your mammogram before being vaccinated with COVID-19 vaccine or waiting to get your mammogram until four to six weeks after getting your final dose of vaccine (i.e., four to six weeks after the second dose of a two-dose vaccine or four to six weeks after a one-dose vaccine).
Read about the new CDC: Safe and Proper Sharps Disposal During the COVID-19 Mass Vaccination Campaign which discusses how best to protect people from needlestick injuries while administrating COVID-19 vaccines or while helping at vaccination sites.
Vaccinators are required to give everyone a vaccination card.
The COVID-19 vaccine provider agreement (which each site signed to enroll in the program) states: “Organization must provide a completed COVID-19 vaccination record card to every COVID-19 Vaccine recipient, the adult caregiver accompanying the recipient, or other legal representative. Each COVID-19 Vaccine shipment will include COVID-19 vaccination record cards.”
If a patient needs a new COVID-19 vaccination card, the provider could provide a replacement. MDH does not have replacement COVID-19 vaccination cards. If providers do not have cards, you can provide the patient with their MIIC vaccination record, or patients can request a copy of their vaccination record once they are fully vaccinated at Find My Immunization Record.
Find more information on vaccine cards for patients at About COVID-19 Vaccine: Getting Vaccinated under “record of vaccination.”
Last week, we shared that we are offering providers the optional opportunity to enroll in VaccineFinder.
It has come to our attention that the email from vaccinefinder@castlighthealth.com to registered sites stated that “as entity enrolled in the COVID-19 Vaccination Program, you will need to report on-hand COVID-19 vaccine inventory to the CDC daily using VaccineFinder.” This is not accurate. MDH will continue to report daily inventory on behalf of all COVID-19 vaccine approved providers that are receiving vaccine from state allocations.
Minnesota’s Find Vaccine Locations map
Help Minnesotans get access to COVID-19 vaccine by adding your clinic information to the State of Minnesota: Find Vaccine Locations map. This page helps Minnesotans search for vaccine clinics near them.
Add or update your location at State of Minnesota COVID-19 Testing and Vaccination Sites.
A new spreadsheet (for the file upload option in MIIC) is now available in MIIC. The new spreadsheet contains race/ethnicity and phone number fields. Please continue to send these data as well as a complete and accurate address for each client and vaccine given.
As vaccine supply increases, we expect Monday delivery timelines may be delayed for Moderna and Janssen (Johnson & Johnson) vaccine orders. Many orders that were processed for Monday delivery last week did not arrive until Tuesday. This is likely to continue for the foreseeable future due to increased vaccine supply nationwide. Please plan accordingly when scheduling appointments.
MDH is working with providers on reminder/recall plans to get patients who are overdue for the second dose of COVID-19 vaccine back into the facility to receive the second dose. Please implement reminder/recall efforts to ensure that patients receive both doses of COVID-19 vaccine in the two-dose series (Pfizer and Moderna). The MIIC outreach team will continue to reach out to organizations with large numbers of clients overdue for second doses.
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