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Minnesota Department of Health
October 21, 2021
Good afternoon,
Here are the COVID-19 vaccine provider updates for Oct. 15 to Oct. 21, 2021.
On October 20, the Food and Drug Administration (FDA) authorized booster doses for both Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines. Learn more at Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines. CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting today, October 21, to discuss booster doses for Moderna and Janssen vaccines. ACIP must provide clinical recommendations and the CDC Director needs to approve before providers can administer heterologous (“mix and match”) booster doses or booster doses of Moderna and Janssen vaccines. Giving COVID-19 vaccines outside of FDA authorization and ACIP recommendations goes against the CDC COVID-19 vaccine provider agreement. We will send out an additional update tomorrow, October 22, with more information.
We anticipate the authorization of Pfizer-BioNTech COVID-19 vaccine down to age 5 in the coming weeks. The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet October 26 to discuss Pfizer’s application. ACIP is scheduled to discuss and vote on the topic November 2-3, pending FDA authorization. If your system or clinic will vaccinate children in this age group and you are currently only using Moderna vaccine, this is the time to consider adding Pfizer to your inventory so you can vaccinate kids from 5-17 years old.
Details on the vaccine
The vaccine for 5-11-year-olds is packaged differently than the current adult/adolescent vaccine (for people down to age 12 years) because younger-aged children will be receiving a smaller dose. It will not be acceptable to make a pediatric dose from the adult vaccine.
The 5–11-year-old pediatric vial will have an orange label and an orange cap and will have different storage and handling requirements than the adult/adolescent vaccine currently in the field. The product can be kept in the ultra-low cold freezer for up to six months and in the refrigerator for up to 10 weeks. This product CANNOT be stored in the regular freezer. The pediatric vaccine will come in 100 dose packages (10 multi-dose vials without preservative with 10 doses per vial).
Pre-book now open for COVID-19 vaccine for 5-11-year-olds
The pre-book event for the first week of the pediatric COVID-19 vaccination campaign is now open in MIIC through Monday, October 25. You must be enrolled in the COVID-19 vaccine program to order pediatric COVID-19 vaccine. Place a request for vaccine using the “Request Special Event Vaccine” functionality in the Minnesota Immunization Information Connection (MIIC) to cover your needs for the first week of the campaign. Refer to our Special Event Vaccine Request (PDF) user guide for instructions on how to use this functionality. Pharmacies enrolled in the Federal Retail Pharmacy Program (FRPP) should request doses via their CDC FRPP contacts.
We anticipate shipping will begin once the emergency use authorization (EUA) is granted and will continue over the course of that week. Please check your email for shipping confirmation. Because of the rolling nature of orders, some sites may receive shipments a couple days before others. Reminder: You may not begin administering the pediatric COVID-19 vaccine until ACIP makes a recommendation. ACIP is expected to meet the first week of November to discuss the pediatric COVID-19 vaccine.
After the pre-book for the initial week of the campaign, the window to request additional vaccine will re-open each week. At that time the minimum order quantity is expected to be 100 doses. Please note that second doses will not automatically be shipped. You must manage your inventory for second doses and request first and second dose needs in future weeks. Pfizer expects shipping timelines to remain the same (three-five days for shipment once order is placed).
Order Pfizer adult/adolescent vaccine now
In order to maximize delivery of pediatric doses, adult/adolescent Pfizer COVID-19 vaccine ordering will be suspended beginning Friday, October 29 through Wednesday, November 3, 2021, and no vaccine will be shipped the week of November 1-5. Please plan ahead and request Pfizer adult/adolescent COVID-19 vaccine doses soon to cover your needs during that time.
Upcoming webinar
MDH will be hosting a live webinar on Thursday, October 28 from noon – 1 p.m. on specifics for Pfizer COVID-19 vaccine for ages 5-11 years. Click here to join the Microsoft Teams Live Event.
Pfizer U.S. Medical Affairs is hosting “Medical Updates” for its COVID-19 vaccine. 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 links below to join the sessions at the designated times.
We have posted additional information and resources on planning for vaccinating 5-11-year-olds, especially for COVID-19-enrolled providers who have not been traditional vaccinators for younger children. Find it at Preparing to Vaccinate Young Children: COVID-19.
We want to raise awareness about the expected authorization of the Pfizer vaccine for children ages 5-11 among parents and caregivers. Keeping parents up to speed on when and why their child should get vaccinated is critically important to keeping children safe and slowing the spread of COVID-19. Please help us share information about the safety of the vaccine and why it is important for children to get vaccinated with families in your circles.
We have several resources on our website that may help you:
Additionally, here are some social media messages that you can use to share information:
Seventy-eight lots of Moderna vaccine received a shelf-life extension from FDA. However, Moderna has been very slow at entering the updated expiration dates into their site. Most of the vaccine that expired in September and October may have an additional two-month extension. Please continue to check the Moderna expiration date lookup site at Moderna: How To Look Up Vial Expiration Date before disposing of presumably expired Moderna vaccine to see if your product is included in this set of lots. You can also confirm all expiration dates using the QR code on the Moderna vial. The extensions will only apply to vaccine still in the freezer. If the vaccine has already been moved to the fridge, it expires on the original expiration date.
Please refer to Moderna’s website for more information. If the website does not reflect these changes yet, Moderna has said it should be up to date soon. Consider ordering new Moderna vaccine if your vaccine is expired, and you are waiting for them to add in your lot.
If you are still awaiting an expiration extension of your lot, mark any expired Moderna vials “DO NOT USE.”
Per the CDC Provider Agreement, COVID-19 vaccine providers must report administered COVID-19 immunizations to MIIC within 24 hours of vaccine administration. Please review your current workflow for getting doses administered data to MIIC and ensure you are meeting this reporting timeframe.
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 must upload the immunization spreadsheet or hand-enter the data in MIIC within 24 hours of administration. This step is in addition to documenting administration of the vaccine within your EHR or other record-keeping system. Learn more 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.
MDH is working with a number of COVID-19 vaccine providers using Minnesota Immunization Information Connection (MIIC) functionality to send text messages to their patients who meet age and previous dose requirements for COVID-19 vaccine booster doses per ACIP recommendations. Texts are sent after a client is past the eligibility date for a booster dose. Clients usually receive a total of three texts, each spaced two weeks apart. They receive the texts until they 1) receive the intended dose, 2) opt out of the text messages, or 3) have received three total texts. The program is free to provider organizations.
In addition to health systems, primary care clinics, and local public health, the MDH MIIC team has specific interest in partnering with providers who serve high numbers or percentages of clients who live in high Social Vulnerability Index (SVI) ZIP codes.
This texting program is also used to reach patients overdue for a second dose of COVID-19 vaccine and those eligible for additional doses. For second dose texting, MDH is currently partnering with local public health, health systems, federally-qualified health centers (FQHCs), and pharmacies.
If you would like to partner on this project, please reach out to the MIIC Help Desk. It usually takes only one 30-minute meeting with a partner organization to move this work forward.
A webinar co-hosted by the Association of Immunization Managers (AIM) and the National Association of School Nurses (NASN) will be held on Tuesday, October 26 at 3:30 p.m. ET and will feature insights from immunization and school nurse leaders from across the U.S. This webinar will be accredited for Continuing Nursing Education through NASN.
Register at GoToWebinar Registration: Opportunities to Improve Student Community Health Through School-Located Vaccinations. Please note you will not receive a confirmation email.
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