COVID-19 Vaccine Provider Weekly Updates

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COVID-19 Vaccine Provider Weekly Updates

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Minnesota Department of Health

Nov. 4, 2021

 

Good afternoon,

Here are the COVID-19 vaccine provider updates for Oct. 29 to Nov. 4, 2021.

COVID-19 vaccine for 5- to 11-year-olds

Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11 years (orange cap) has been authorized by the FDA and recommended by CDC. Providers can begin vaccinating this age group. Read more in our message sent out yesterday afternoon at COVID-19 Vaccine Provider Updates.

Please note in the EUA fact sheet that there is clarification that the vaccine for 5- to 11-year-olds (orange cap) can be used for up to 12 hours after reconstituting. This is different than the six-hour limit for the vaccine for people 12 years and older (purple cap).

Expiration versus manufacture date

Pfizer COVID-19 vaccine for children 5- to 11-year-olds (orange cap) has been arriving at provider sites who pre-booked vaccine. This formulation does not have an expiration printed on the vial. Instead, each vial has the lot number and date of manufacture printed on the label. The vaccine expires six months from the date of manufacture. For example, vaccine that was manufactured 08/2021 expires 1/31/2022.

The QR code provided on the carton provides a link to the emergency use authorization. It does not provide information on expiration dates.

CDC will have clinical materials to assist with tracking expiration and beyond-use dates posted soon.

Pfizer orange cap vial with date printed on it

Courtesy of U.S. Health and Human Services

Age change after initial dose

Children should receive the vaccine dosage and formulation based on their age on the day of vaccination with each dose (e.g., if the child is age 11 when they receive the initial dose, they should receive the 10-mcg dose (orange cap)). For the very few children who turn 12 years old between the first and second dose, they should receive the 30-mcg dose (purple cap) for the second dose.

For further guidance review the updated CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: Vaccination of children and adolescents.

Pediatric dose interval reminders

When vaccinating children 5 to 11 years with Pfizer-BioNTech COVID-19 vaccine (orange cap), please remember that the same guidance for adult/adolescent dose intervals also applies to children 5 to 11 years. The second dose of Pfizer COVID-19 vaccine should be administered 21 days after the first dose and not scheduled before that time. It should not be routine practice to schedule outside of the indicated intervals. We have limited data for efficacy of mRNA vaccines administration outside of this window, especially if vaccine is given earlier than 21 days. Vaccinators should be scheduling both the first and second doses at the same time following the recommended dose intervals.

Review the EUA fact sheet for providers Healthcare Providers for Ages 5-11 years (PDF) and learn more at CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States: COVID-19 vaccine dosing and schedule.

COVID-19 vaccine provider material updates coming soon

We are working on updating our materials for the Pfizer vaccine for 5- to 11-year-olds in the coming days. You can find our updated materials at COVID-19 Vaccine Providers.


COVID-19 vaccine for 5 to 11 years distribution updates

Timing of next MIIC pediatric vaccine ordering events

The next ordering event for pediatric COVID-19 vaccines will open on Friday, November 5, and will close at 4:30 p.m. on Monday, November 8. Orders will be processed by Wednesday, November 10. Minimum order sizes will be 100 doses. Thereafter, we will continue to open ordering events for pediatric COVID-19 vaccine on Fridays and close at the end of the day (4:30 p.m.) on Mondays until we know we can ensure all provider requests can be filled each week. Please note this change in cadence from last week’s bulletin. You must be enrolled in the COVID-19 vaccine program to order pediatric COVID-19 vaccine. Pharmacies enrolled in the Federal Retail Pharmacy Program (FRPP) should request doses via their CDC FRPP contacts.

Shipping

Pre-booked pediatric doses from the initial allocation have already begun shipping. Please check your email for shipping confirmation emails from Pfizer. Because of the rolling nature of orders, some sites may receive shipments a couple days before others. 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. Due to the timing of ordering and shipping, you can expect to receive your shipment of vaccine between Friday and Tuesday the following weeks. For example, if you place your request in MIIC on Friday November 5, you can expect to receive your shipment between November 12-16.


New webpages for COVID-19 vaccines for children

CDC has a new page on COVID-19 Vaccination for Children 5 through 11 Years Old that providers may find helpful as it shares up-to-date information and resources to aid in COVID-19 vaccination among children ages 5 to 11.

The State of Minnesota also has a new page for COVID-19 Vaccine for Children and Teens that can serve as a great resource for parents to find information on the COVID-19 vaccine and where to get their children vaccinated.


Pfizer COVID-19 vaccine trainings on vaccinating 5- to 11-year-olds

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.


COVID-19 booster doses for people who were vaccinated outside of the U.S. or who participated in U.S. clinical trials

The emergency use authorizations (EUAs) for the vaccines currently available in the United States only allow for booster doses to be administered following completion of a primary vaccination with another FDA-authorized or FDA-approved COVID-19 vaccine. Currently, there are no recommendations on booster doses for people who have received a COVID-19 vaccine outside of the U.S. or through participating in a U.S. clinical trial with a vaccine that is not FDA-authorized or approved for their primary series. People who were enrolled in these U.S. clinical trials may want to reach out to the investigators of their clinical trial for any additional information as it becomes available. For additional details, refer to CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: People vaccinated for prevention of COVID-19 outside the United States and CDC Interim Clinical Considerations for Use of COVID-19 Vaccines: People vaccinated for prevention of COVID-19 as part of a clinical trial in the United States. We will provide updates on booster dose guidance when we have it.

It is important to remember that vaccines continue to protect against severe disease and hospitalization after the primary series.


Moderna webinars for booster dose updates

Join Moderna for a webinar for vaccination providers to learn more about the Moderna COVID-19 vaccine booster dose. There will be no continuing education offered for this webinar.

Please register at the link below for the available session:


COVID-19 vaccine name changes in MIIC

The names of the Pfizer and Moderna COVID-19 vaccines have been changed in MIIC as follows:

  • Pfizer (Comirnaty) is now Comirnaty-PFR
  • Moderna (Spikevax) is now Spikevax-MOD.

These changes occurred to make the names short enough for various types of data exchange (the process of sharing information between two systems), as well as to match the nomenclature of other vaccine tradenames and manufacturers in the MIIC system.

  • Comirnaty-PFR 30 mcg – is the vaccine for people 12 years and older (purple cap)
  • Comirnaty-PFR t-s 10 mcg – is the vaccine for children 5-11 years (orange cap)

If you have any questions about this change, please contact the Help Desk.


Updated forecaster in MIIC

The forecaster is updated in MIIC to recommend Comirnaty-PFR (formerly Pfizer (Comirnaty)) COVID-19 vaccine for children ages 5-11. If you have any questions, please contact the MIIC Help Desk.


MIIC assessment report and client follow-up

A reminder that MIIC can be used to run a report to assess and monitor COVID-19 immunization coverage rates over time for your organization. Knowing your coverage rates can help in vaccination planning and provide helpful context for determining your organization’s need for reminder/recall activities for COVID-19 vaccination. 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. These lists can be used for vaccination planning and reminder/recall with clients. Please keep this in mind for the expanded age range and getting kids ages 5-11 in for their primary COVID-19 vaccine series. Please find the user guidance at Client Follow-up.

Please contact the MIIC Help Desk with any questions you have!


Receiving an “EXCEPTION” status after loading files into the MIIC user interface

There are several reasons to load a file directly into the MIIC user interface (UI). If you are loading any file in the UI and its status reads "EXCEPTION," please contact the MIIC Help Desk with your organization code and the job ID. This status occurs when there is a problem that must be resolved before the work can proceed. Please do not attempt to re-upload the file until the MIIC team has worked to resolve the issue.


Please direct questions on Docket to the MIIC website

Our Find My Immunization Record page has a wealth of information on using the Docket app and requesting records via MIIC. If patients have questions about Docket (such as technical problems with the app, including downloading it or logging in), please do not direct them to call MDH. Instead, direct them to Find My Immunization Record to help them troubleshoot their issue (such as a wrong phone number/name in MIIC, missing immunizations, etc.). This allows the person to determine if they need to contact MDH about a MIIC data issue or Docket for a technical issue.


Moderna vaccine management and wastage reporting with half doses

When extracting only booster doses, or a combination of primary series and booster doses, from a Moderna vial, the maximum number of doses that may be extracted from either vial presentation should not exceed 20 doses, as the vial stopper cannot be punctured more than 20 times. Wastage should be reported only as whole doses.

  • For a Moderna-14 vial, wastage should only be reported up to 14 doses; do not report wastage over 14 doses, even though you can administer up to 20 booster doses from one vial.
  • For a Moderna-10 vial, wastage should only be reported up to 10 doses; do not report wastage over 10 doses, even though you can administer up to 20 booster doses from one vial. 

Tables with more detail on wastage reporting are now available in our user guide: Reporting Nonviable COVID-19 Vaccine to MIIC (PDF).


Report excess vaccine inventory in SmartSheet tool

Providers with excess inventory of COVID-19 vaccine doses that would better serve the community if they were redistributed to other sites should fill out the COVID-19 Vaccine Available for Redistribution. If your doses could be redistributed to another site, MDH staff will contact you to facilitate that process.

If you have questions regarding this tool, please email health.mdhvaccine@state.mn.us.


Moderna COVID-19 vaccine expiration extension

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.”

Expired/expiring Moderna doses 

The listed batches of Moderna vaccine in this PDF are not subject to an extension of their expiration date: ModernaVaccineNOTSubjecttoExpirationExtension.pdf. Prioritize unexpired lots and use according to their expiration dates. Please try to use all doses prior to expiration to help reduce wastage.

Expired lots on this list must not be used and should be discarded. 

Find previous bulletins at COVID-19 Vaccine Provider Updates.