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Minnesota Department of Health
Nov. 18, 2021
Good afternoon,
Here are the COVID-19 vaccine provider updates for Nov. 12 to Nov. 18, 2021.
Both Pfizer and Moderna have applied to FDA for expansion of the EUA to include booster doses for all people 18 years and older. It is anticipated that FDA will authorize the expansion this week and ACIP will meet Friday, November 19 to discuss the recommendation. Please continue to prioritize people at highest risk for severe COVID-19 disease for boosters.
Efforts to maximize the proportion of people who are fully vaccinated against COVID-19 are still critical to ending the COVID-19 pandemic; the priority remains getting the unvaccinated vaccinated.
On November 17, 2021, CDC issued Emergency Use Instructions (EUI) to allow the Pfizer-BioNTech COVID-19 vaccine to be given as an additional primary dose or booster dose to certain people who completed a vaccine primary series with certain COVID-19 vaccines that are not authorized or approved by the U.S. Food and Drug Administration. Refer to CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines under the sections “People vaccinated for prevention of COVID-19 outside the United States” and “People who received COVID-19 vaccine as part of a clinical trial” for further guidance.
It continues to be important to limit the potential spread of COVID-19 in vaccine clinics and protect vaccinators. These points can be shared with your patients to limit potential COVID-19 exposure in your clinics:
- If you or your child have been identified as a close contact of someone with COVID-19, especially if that person lives with you/your child, wait to get vaccinated for 14 days (quarantine period). This recommendation applies even if your child has a shortened quarantine. Waiting to get vaccinated helps make sure that any side effects experienced after vaccination are just from the vaccine, and not COVID-19 symptoms.
- If you or your child has a mild illness (e.g., sore throat, stuffy nose, etc.), get tested for COVID-19 and wait until symptoms have improved and until you or your child have been fever-free for 24 hours before getting vaccinated.
You can also find this information on About COVID-19 Vaccine: How to get vaccinated under “If you have had recent close contact or mild illness.”
Labels on the Pfizer vials for 5- to 11-year-olds (orange label) were printed before the FDA authorized the vaccine for this age group. In anticipation of approval, the orange labels were printed with “Discard 6 hours after dilution.” However, FDA said the vaccine can be used for 12 hours after dilution before discarding. This updated information is stated in the EUA and fact sheet for Healthcare Providers for 5-11 years of age, orange cap, (must dilute) (PDF) on page 3.
ALL Pfizer vaccine for 5- to 11-year-olds should be discarded 12 hours after dilution.
 Pfizer orange vial label should read "discard 12 hours after dilution."
The Institute for Safe Medication Practices (ISMP) published a featured article titled Adult and Pediatric Coronavirus Disease 2019 (COVID-19) Vaccine Mix-Ups Are Predictable in the November 4 issue of Medication Safety Alert.
ISMP is concerned about the potential for mix-ups between the two formulations of the Pfizer COVID-19 vaccine (for children 5-11 years (orange cap) and people 12 years and older (purple cap)) since both will be available in most vaccination sites.
We encourage you to read the full article and use their safe-practice recommendations for staff training.
Use the box and shipping label included in the single use shipping container to return the Controlant data logger from the Pfizer vaccine for children 5-11 years (orange cap) vaccine. Pfizer needs them returned to be able to ship out additional vaccine. Delay in returning them may result in shipping delays for future vaccine.
The next ordering event for COVID-19 vaccine for children 5 to 11 years (orange cap) will open on Friday, November 26, and will close at 4:30 p.m. on Monday, November 29. Orders will be processed by Wednesday, December 1. Minimum order sizes will be 100 doses.
Shipping of vaccine is on hold for all COVID-19 vaccines Wednesday through Friday of Thanksgiving week (November 24-26). MDH will not automatically ship second doses. Sites are responsible for anticipating their second dose inventory needs and ordering accordingly.
Sites must report doses administered to MIIC within 24 hours, per the CDC Provider Agreement. We monitor inventory levels before approving COVID-19 requests. This will be especially important for the 5- to 11-year-old vaccine going forward. Over-ordering increases risk of product expiring. Order what you need and use what you order. Further, CDC is using our doses administered data to calculate a statewide on-hand inventory level for the 5-11-year-old vaccine product. This helps them determine future allocations for Minnesota. Please review your current workflow for getting doses administered data to MIIC and ensure you are meeting this reporting timeframe.
Electronic data exchange
Organizations are encouraged to participate in electronic data exchange with MIIC. An HL7 interface between your Electronic Health Record (EHR) and MIIC allows data documented in your EHR to “flow” into MIIC. You would only need to document administration of the vaccine in your EHR and your EHR will electronically send the vaccine data to MIIC. Learn more at Submitting and Exchanging Data with MIIC. Creating a new interface with MIIC takes time and technical resources. If you have questions or would like to start the onboarding process, please contact the MIIC Help Desk.
If your organization is unable to submit data via an HL7 interface, you will likely need to do enter data both into your EHR and MIIC. Manual entry into MIIC can happen one of two ways. You must either use an immunization spreadsheet to upload a batch of doses administered data or directly enter the data into the MIIC user interface within 24 hours of administration. Learn more about uploading the immunization spreadsheet at MIIC User Guidance and Training Resources under “Entering information.”
Thank you for your continued efforts to report quality data to MIIC in a timely manner.
Quality data is crucial to understanding immunization rates, supporting clients to complete their primary series and booster doses, and implementing reporting efforts. When entering data into the MIIC interface:
- Please ensure that the correct vaccine code for a vaccine is entered.
- Please enter doses that a client received at another facilityas “historical.”
- Enter doses given by the organization who is entering them into MIIC (administered doses) as “administered.”
- Please make sure that correct date of vaccinationis entered into MIIC for all doses of vaccine.
- Ensure that correct vaccine product name is included with each dose.
School-located vaccination clinics help to make vaccination as accessible as possible to students. CDC has created a guide that provides a roadmap for school district administrators to work directly with health departments and other vaccine providers to set up K-12 vaccination clinics. Check out this new resource at CDC School-Located Vaccination Clinics: Best Practices for School Districts.
Pfizer U.S. Medical Affairs is hosting “Medical Updates” for its COVID-19 vaccine for 5- to 11-year-olds. Topics include FDA indication & authorization, CDC/ACIP recommendations, packaging/presentation, storage and handling, and a Q&A session.
Each session will be unique and will reflect any new information or changes that emerge. Click on the link below to join the session at the designated time.
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