COVID-19: Program Information for Vaccinators

"Office Hours" for Vaccinators

Join our weekly "office hours" for vaccinators every Tuesday from 9:00-9:45 a.m.!
Stakeholder webinars will continue on Fridays from 10:00-10:45 a.m.

Once you register, you can use the same Zoom link every week.
Check out the recordings of past webinars.

Immediate Pause on All Use of Johnson & Johnson Vaccine

Today, April 13, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued a joint statement on Johnson & Johnson COVID-19 Vaccine, recommending an immediate pause in the use of Johnson & Johnson vaccine. U.S. CDC and FDA are reviewing data involving six reported U.S. cases (of 6.8 million administered doses of the Johnson & Johnson COVID-19 vaccine) of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine. The Wisconsin Department of Health Services (DHS) is following this recommendation and instructing all vaccinators to immediately pause all administration of Johnson & Johnson vaccine.

  • DHS asks that vaccinators continue to properly store inventories of Johnson & Johnson, and not to discard inventories. Please properly label vaccine with DO NOT USE to assure all know the status of the vaccine.
  • Vaccinators should communicate with their patients who have received Johnson & Johnson within the last three weeks to watch for severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination. If patients experience any of these symptoms, they should contact their health care provider. Health care providers should report reactions to COVID-19 vaccines to the Vaccine Adverse Event Reporting System (VAERS).
  • CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14, 2021 from 12:30 p.m. to 3:00 p.m. CT to further review these cases and assess their potential significance. The agenda and webcast links are available on the ACIP website. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Note:

  • Some J&J/Janssen doses will be delivered today, Tuesday, April 13, as scheduled. Please receive, inspect, and store these deliveries.
  • Existing J&J/Janssen inventory at your enrolled provider sites should be held between 2°C and 8°C (36°F and 46°F) and labeled “Do not use. Awaiting guidance.”
  • Follow vaccine storage practices and continue to monitor and document storage unit temperatures.
  • Unfilled orders for J&J/Janssen submitted prior to this guidance will be held until further notice.
  • No new orders for J&J/Janssen will be accepted at this time.
  • No J&J/Janssen doses should be administered at this time.

As a COVID-19 Vaccination Provider with Janssen (Johnson & Johnson) vaccine, please immediately implement the following CDC operational guidance until further notice:

  1. Mark any Janssen/J&J vaccine in your inventory “Do not use. Awaiting guidance.”
  2. Continue to store the vaccine in the refrigerator between 2°C and 8°C (36°F and 46°F).
  3. Follow vaccine storage practices and continue to monitor and document storage unit temperatures.

For more information, see the CDC's Health Alert on the topic.

 Guidance for providers eligible to administer COVID-19 vaccine under the PREP Act

Joint Guidance on PREP Act March 11, 2021 Seventh Amendment from:

  • Department of Health Services
  • Department of Safety and Professional Services
  • Wisconsin Veterinary Examining Board

Licensed health professionals or other individuals authorized by the state of Wisconsin may administer COVID-19 vaccines. Providers should always consult their governing laws and any policies or guidance issued by the regulatory program, board, or commission for their profession, as well as the Declaration under Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 referred to as the “PREP Act of 2020.” Providers are responsible for complying with the standards of practice and any other legal requirements applicable to their profession when ordering or administering vaccines in the state of Wisconsin. Please refer to the State of Wisconsin Department of Safety and Professional Services for additional information.

In addition to licensed health professionals or other individuals authorized by the state of Wisconsin, through the Public Readiness and Emergency Preparedness (PREP) Act Declaration, the federal government has provided a pathway for state, local, territorial, and tribal (SLTT) governments to rapidly expand and support their vaccination workforces as needed. In March 2020, the HHS Secretary issued the PREP Act of 2020 covering COVID-19 tests, drugs, and vaccines providing liability protections to manufacturers, distributors, SLTTs, licensed healthcare professional, and others (qualified persons) identified by the HHS Secretary who administer COVID-19 countermeasures. On March 11, 2021, the Acting Secretary of HHS issued the PREP Act Seventh Amendment to extend liability protections to specified healthcare professionals who may not usually administer vaccines in their scope of practice or who have recently expired licenses, and students of specified healthcare professions who administer COVID-19 vaccines.

The Department of Safety and Professional Services and the Department of Health Services have deemed that the following healthcare professionals who hold an active credential under the law of any state, or hold a credential that has expired, become inactive, or lapsed within the last five years and was in good standing when it expired, lapsed, or became inactive, and who meets the all requirements under the PREP Act Seventh Amendment, are authorized under the PREP Act Seventh Amendment to administer FDA authorized, approved or licensed COVID-19 vaccines in Wisconsin.

Health Professionals (currently licensed, certified, or registered or had active license, certification, or registration within the last 5 years):

  • Physicians
  • Registered Nurses
  • Licensed Practical Nurses
  • Advanced Practice Registered Nurses
  • Pharmacists
  • Pharmacy Interns
  • Midwives
  • Physician Assistants
  • Respiratory Therapists
  • Dentists
  • Podiatrists
  • Optometrists
  • Emergency medical services providers (EMT, AEMT, EMT Intermediate, or Paramedic)
Healthcare Students:

Students in a medical, nursing, pharmacy, pharmacy intern, midwife, physician assistant, respiratory therapy, dental, podiatry, or optometry training program may also administer FDA authorized, approved, or licensed COVID-19 vaccines in Wisconsin pursuant to the PREP Act Seventh Amendment.

 

Veterinary Students:

Students in a veterinary medicine program may also administer FDA authorized, approved, or licensed COVID-19 vaccines in Wisconsin pursuant to the PREP Act Seventh Amendment. Students administering vaccine must have appropriate training in administering vaccines as determined by the student’s school. Students must also be supervised by a currently practicing healthcare professional with experience in administering intramuscular injections.

Licensed Veterinarians

The Veterinary Examining Board (VEB) has deemed all veterinarians licensed by Veterinary Examining Board (VEB), attached to the Department of Agriculture, Trade, and Consumer Protection, or who has a credential that has expired, become inactive, or lapsed within the last five years and was in good standing when it expired, lapsed, or became inactive, from any jurisdiction, and who meets all requirements under PREP Act Seventh Amendment, as authorized under the PREP Act Seventh Amendment, may administer FDA authorized, approved or licensed COVID-19 vaccines in Wisconsin if properly trained per Department of Health Services requirements.

All Professionals and Students

All professionals and students must meet and comply with all applicable requirements outlined in the PREP Act 2020 Declaration and Amendments, as well as any additional training required by the state, territory, locality, or Tribal area in which they are prescribing, dispensing or administering COVID-19 vaccines.

To become a part of the expanded COVID-19 vaccine workforce in Wisconsin, you will need to determine if you meet eligibility requirements and training under the PREP Act of 2020. Subject to certain requirements and if eligible, PREP Act coverage provides liability protections under federal and state/territorial law with respect to all claims for loss resulting from the administration or use of a covered countermeasure in this case COVID-19 vaccine. Some professions may have limitations related to delegation, supervision, training, settings, etc. when ordering or administering vaccines. We encourage providers to consult with their specific program, board or commission for guidance specific to their profession.

Department of Health Services Training Requirements prior to becoming a COVID-19 vaccinator can be found in the training section below.

 

At this time, the Department of Health Services is not seeking additional locations to administer the COVID-19 vaccine. Individuals interested in administering vaccine are encouraged to enroll through the Wisconsin Emergency Assistance Volunteer Registry(WEAVR) and indicate their interest in providing COVID-19 vaccine. The Department of Health Services will query individuals enrolled in WEAVR as additional vaccinators are needed to support on site clinics.

 Vaccine Allocation and Ordering

Summary of this section:

  • Providers should NOT submit a new allocation request for the second dose. The Department of Health Services will be allocating and distributing the same amount of second dose vials as were allocated for first doses.
  • In the unfortunate event of vaccine wastage, vaccinators must report it in WIR and through the Wastage Report.
Allocation of First and Second Doses

The Department of Health Services will be allocating and distributing second doses, also called booster doses, to all COVID-19 vaccinators. Providers should NOT submit a new allocation request for the second dose. This allocation will be of the same amount of vials as the first allocation. For example, if you receive 20 doses of Moderna COVID-19 vaccine, administer them to 20 individuals as their first dose. In 4 weeks, you will receive another 20 doses Moderna COVID-19 vaccine for these individuals to complete their series. Due to this automatic allocation of second doses, all vaccinators are expected to provide the second dose to those they have vaccinated. Vaccinators cannot refuse to provide the second dose to prior employees, residents, or participants to which they provided the first dose.

You may give a second dose to individuals who received their first dose elsewhere but were not able to return to that location. These individuals should not be turned away. All efforts to vaccinate them should be made if appropriate vaccine product is available.

The Department anticipates that the dose variability for both the Pfizer and Moderna vaccines will continue. In the event that the vials in your second order do not include additional supply, please contact us. We also encourage all providers to continuously re-review their administration protocols to ensure that "extra" doses or the lack of ability to draw the number of doses on the product label are due to ancillary supplies and not other factors such as technique or human error.

 If you cannot use all of the doses you ordered, please contact the Program and we will help to coordinate a transfer.


Reducing Wasted Vaccines

In keeping with being good stewards of public resources, it is imperative that vaccinators mitigate vaccine wastage to the best of their ability. There are several best practices to do so.

  1. Scheduling Practices: Schedule vaccination appointments in accordance with your vaccine inventory and your clinics’ anticipated patient throughput.
  2. Estimate your Population Correctly: Accurately estimate how many doses you need. If possible, prior to a vaccination clinic, screen your patients for eligibility and acceptance and plan accordingly for how many doses you will need.
  3. Only Open Vials as Needed: Make sure you only have one vial open at any given time even if you have multiple vaccinators working concurrently at a clinic.

If after implementing the above steps, vaccinators have extra vials or doses at the end of a vaccination clinic, there are some additional strategies to further reduce vaccine wastage from occurring.

  1. Recruit Eligible Individuals: Recruit additional eligible individuals to be vaccinated. Consider outreaching to organizations in your area (e.g., aging and disability resource centers; smaller healthcare agencies) to see if they know of eligible individuals who could come in at the end of the clinic, or the next day.
  2. Create a Stand-by List: A list of eligible individuals who could come in sooner than their future scheduled appointment.
  3. Unplanned Redistribution: If you are approaching the expiration date (i.e., 120 hours for Pfizer or 30 days for Moderna), you can contact your DHS regional manager (if you have one) or email DHS. DHS can attempt to get those unopened vials to another nearby clinic to use. Do not do this on your own.
  4. Last Resort Vaccination: If you identify you have additional doses due to an opened vial at the end of a vaccination clinic day, you are encouraged to use the remaining doses instead of wasting vaccine. DHS strongly encourages all vaccinators to establish protocols to identify individuals who are in the currently eligible group for this extra vaccine before administering vaccine to other individuals who may be readily available but not yet eligible.

In the unfortunate event of vaccine wastage, vaccinators must report it in two ways.

  1. Report in WIR: In the event of vaccine wastage, vaccinators must report it in WIR as soon as possible and within 24 hours of identifying the vaccine wastage (see WIR training for detailed instructions). In brief, to report wastage in WIR navigate to your inventory site in WIR. Select the appropriate vaccine/lot with wastage. Update the inventory to reflect the amount of doses wasted and indicate the reason why as, “doses wasted.”
  2. Wastage Report (FORM #02768): Use this form to record and report vaccine that is disposed of according to your clinic guidelines for disposal of biologics. You will need to state the number of doses that were wasted and why and email the form to DHSCOVIDVaccinator@wi.gov.

After reporting vaccine wastage, you may be contacted by DHS staff for further details and with technical assistance about how to avoid similar wastage in the future.

 Vaccination Clinical Guidance (Updated 04/13/2021)

 
CDC Clinical Considerations
Always check this for the most updated, detailed information.
 
 

Updates  

  • Added Modern and Johnson & Johnson Temperature Excursion Tools. (Added 04/13/2021)
  • Product-specific tabs have been updated with new contact information for addressing problems. (Updated 04/13/2021)
  • New CDC resources available for health care providers above. (Added 03/30/21)
  • Added reminders about the interval between mRNA doses and the verification of eligibility. (Added 03/30/21)
  • The number of doses per vial has been clarified by the CDC. Withdraw only the number of doses authorized in the emergency use authorization (EUA) for the specific vaccine. Never try to pool vaccine from multiple vials to make a full dose. (Added 03/22/21)
 
Vaccine Doses per vial Volume Number of doses Dose interval
Pfizer 6 0.3 mL 2 3 weeks (21 days)
Moderna 10 0.5 mL 2 1 month (28 days)
Johnson & Johnson 5 0.5 mL 1 N/A
Doses Per Vial

Withdraw only the number of doses authorized in the emergency use authorization (EUA) for the specific vaccine. Discard the vaccine vial and remaining vaccine. Never try to pool vaccine from multiple vials to make a full dose. Although no one wants to waste vaccine, it is crucial for infection control and patient safety to administer vaccine properly. Combining or pooling vaccine from multiple vials can result in cross-contamination, potentially causing a serious bacterial infection in patients.

Per the FDA, in some cases, providers may be able to obtain an 11th dose from a Moderna vaccine vial, and this may be used if it is truly a full dose. Do not book appointments for or plan on 11 doses, but if you are able to obtain a full 11th dose from one vial, it can be used.(Added 03/22/21)

Interval between mRNA doses

The second dose of Pfizer-BioNTech and Moderna vaccines should be administered as close to the recommended interval as possible, but not earlier than recommended (i.e., 3 weeks [Pfizer-BioNTech] or 1 month [Moderna]).

However, second doses administered within a grace period of 4 days earlier than the recommended date for the second dose are still considered valid. If it is not feasible to adhere to the recommended interval and a delay in vaccination is unavoidable, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be administered up to 6 weeks (42 days) after the first dose.
 (Added 03/30/21)

 
Verification of Eligibility with ID

While DHS recommends that vaccinators employ a method of verification for those seeking to receive vaccine, it is imperative to do so in a manner that is sensitive to all populations. Vaccinators may ask for ID verification, but may not require it be a state or government ID. In the event a vaccine recipient does not have eligibility documentation, vaccinators are encouraged to ask them to complete a letter of attestation and proceed with vaccination.(Added 03/30/21)


Updated Guidance for Fully Vaccinated Individuals

Fully vaccinated individuals may follow specific quarantine and activity guidelines that differ from those who are not fully vaccinated. Fully vaccinated people should continue to wear masks and practice physical distancing in public spaces and when visiting unvaccinated people at an increased risk for severe COVID-19 disease.(Added 03/22/21)

Avoiding COVID-19 Vaccine Scams

Scammers are trying to take advantage of the COVID-19 vaccine rollout to steal money and personally identifiable information. Learn how you can avoid vaccine scams and share this information with your patients.
 (Added 03/22/21)
 


Physical Security for COVID-19 Vaccine “Points of Distribution” Action Guide

DHS developed two guides to help points of distribution (POD) managers and organizers plan for and respond to potential physical threats. These guides were emailed to vaccine providers on 02/26/21 from widhs@public.govdelivery.com. Local and tribal health departments can also find these guides on the PCA portal.
 (Added 03/02/21)

Product-Specific Clinical Guidance

Currently, Pfizer’s COVID-19 vaccine is the only vaccine with emergency use authorization for individuals 16 or 17 years old. Moderna and Johnson & Johnson COVID-19 vaccines are not authorized for and cannot be administered to 16 or 17 year olds.

Johnson & Johnson, Pfizer, and Moderna COVID-19 vaccine products are not interchangeable. The same COVID-19 product must be administered for both doses of the mRNA COVID-19 vaccine series. ACIP does not state a product preference. A person may receive any recommended COVID-19 vaccine series.

Click on each tab below to see clinical guidance, information and materials for each specific COVID-19 vaccine.

Moderna

On December 18, 2020, the FDA authorized the Moderna COVID-19 Vaccine for emergency use. On December 19 and 20, 2020, the Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the vaccine in individuals 18 years of age and older. Learn more about the evidence that went into ACIP's recommendation for Moderna's EUA. As more evidence becomes available, updates to recommendations or clinical considerations will be posted on the ACIP website.

 Contraindications

Do not administer the Moderna COVID-19 vaccine to individuals with a known history of a severe allergic reaction (for example, anaphylaxis) to any component of the Moderna COVID-19 vaccine. The list of ingredients is available in section 13 "Description" of the EUA fact sheet for vaccinators on page 18.

 Clinical Resources

 Moderna Temperature Excursion Tool to help you see what to do with vials that may have experienced a temperature excursion.

 Ensure that your staff are familiar with the Moderna EUA fact sheet for vaccination providers and give each vaccine recipient the EUA fact sheet for recipients and caregivers in lieu of a vaccine information statement. Find frequently asked questions, translations of the fact sheets, and more information on the FDA's webpage about its emergency use authorization of the Moderna COVID-19 Vaccine.

 Review CDC's Moderna COVID-19 Vaccine webpage for instructions on how to administer, store, and handle the vaccine.

 Check out CDC's resources for Moderna COVID-19 vaccine, also available on the above webpage:

 

Added 03/01/21

Updated Guidance for Transporting Moderna Vaccine to an Off-Site Clinic  

The Moderna COVID-19 Vaccine should be stored and transported in the frozen state at -25°C to -15°C (- 13°F to 5°F) and should not be transported or stored below -40°C (-40°F). There may be circumstances in which frozen state transport is not feasible. In order to transport the vaccine at 2-8°C the following steps must be taken:

  • Vaccine must be monitored at all times with a digital data logger.
  • Vaccine must be transported using a portable vaccine refrigerator/freezer or qualified container and pack-out.
  • Vaccine cartons and vials should be wrapped in bubble wrap or similar padding material inside the container to minimize product/carton movement and exposure to vibrations during transport.
  • Transport vaccines inside the passenger compartment (not in the trunk or bed of a truck, which may be too hot or too cold).
  • Transport containers must be secured (strapped or braced) when being transported to prevent unnecessary movement.
  • Vaccine should only be transported once and should not be transported back again to the point of origin or to a new location.
  • Punctured vials should not be transported.

The Moderna vaccine can be transported more than once. Unpunctured vials can be transported at the frozen temperatures (between -15°C and -25°C [-13°F and 5°F]) or refrigerated temperatures (2°C and 8°C [36°F and 46°F]). Frozen transport is preferred, if possible. 

If the vaccine is being transported at refrigerated temperatures, the total time for transport is 12 hours (cumulative). For example, if the vaccine is transported 1 hour to a clinic and 1 hour back to the primary storage unit, the returned vials have used 2 out of the 12 hour timeframe. These vials can be transported for 10 more hours. The beyond-use date labels for this vaccine have been updated to help providers keep track of transport times. In addition, care should be taken to ensure thawed vaccine does not refreeze.

This information is also included the latest update of the CDC’s Vaccine Storage and Handling Toolkit.

Vaccine Storage and Handling Toolkit | CDC
Moderna COVID-19 Vaccine Information | CDC

Providers must report all temperature excursions (any out-of-range temperatures) to the WI COVID-19 Program within 24 hours at DHSCOVIDVACCINATOR@WI.GOV.

Advance Email Notification for COVID-19 Vaccine Shipments from Distributor, McKesson (added 03/01/21)

Vaccine shipments to providers will be preceded by two emails from McKesson. Both of these emails will be sent from CDCNotifications@mckesson.com and will be sent to the provider (facility) level email address that is transmitted with the order in VTrckS.

  1. An order acknowledgment email that is sent once the order has been received into the McKesson system
  2. An advance shipment email that is sent once the order has shipped from the McKesson depot and contains the carrier tracking details

If you have questions, please contact McKesson Specialty Customer Care at (833) 343-2703 Monday-Friday, 7 a.m.-7 p.m. CST or COVIDVaccineSupport@McKesson.com.

Additional Storage Information (not displayed on the vial labels and cartons)

To find the expiration date for any vial:

  1. Go to the Moderna COVID-19 Vaccine webpage.
  2. On the vial, find the lot number, printed on both the carton and vial.
  3. Enter the lot number in the website search field and press "Submit."

CDC's Vaccine Expiration Date Tracking Tool can help you keep track of the expiration date by lot number.

  • Do not store on dry ice or below -40ºC (-40ºF).
  • Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.
  • Unpunctured vials may be stored between 8° and 25°C (46° and 77°F) for up to 12 hours.
  • Do not refreeze once thawed.
  • Check the expiration date before preparing or administering vaccine. NEVER use expired vaccine or diluent. As additional stability data become available, the expiration dates for some products may change.
Pulling "Extra" Doses from One Moderna Vial 

In some cases, providers may be able to obtain an 11th dose from a Moderna vaccine vial, and this may be used if it is truly a full dose. Whether an 11th dose is obtainable depends, in part, on the type of syringes and needles used to withdraw doses from the vials. Because the vaccine does not contain preservative, it is critical to note that if the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and content. Do not pool excess vaccine from multiple vials to create one dose.

Please be sure to adjust WIR inventory as needed, based on these instances. Inventory can be adjusted as follows:

  1. Review and address any outstanding transfers and current inventory in WIR. It is important to make sure there are no outstanding transfers of vaccine and all inventory is accounted for prior to making adjustments.
  2. Under manage inventory, select “show inventory.”
  3. Select the applicable COVID site in the site dropdown to review the correct vaccine inventory.
  4. Select the correct trade name and lot number by clicking the checkbox next to the applicable vaccine.
  5. Click “modify quantity” in the upper right.
  6. Modify the total doses in inventory, using “receipt of inventory” as the reason for the adjustment.
  7. Click save.

Detailed instructions with screenshots can be found within Chapter 11 of the WIR User Manual (available on the WIR website after you log on). A recorded webinar regarding inventory management can also be found here.

Additional Moderna Resources

 The FDA has launched a webpage with frequently asked questions about the Moderna COVID-19 vaccine.

 Moderna recently launched a website for the Moderna COVID-19 vaccine. It discusses details of Moderna COVID-19 vaccine’s EUA, contraindications, warnings and precautions, adverse reactions, reporting of adverse events and vaccine administration errors, considerations for pregnancy and lactation, dosing, and schedule.

  Moderna has a 24/7 call center, 1-866-MODERNA (1-866-663-3762). Based on their questions, callers will be routed to one of four areas:

  • General Moderna Questions
  • Health Care Provider Questions (clinical)
  • Product Quality or Technical Questions
  • Pregnancy Registry
Contacts to help with addressing problems
I need help with… Contact…
Moderna vaccine shipment has a problem (including temperature excursions during shipment)

Questions/concerns about vaccine viability issues (temperature excursions) during shipment must be reported on the same day as delivery.

 Phone: 1-833-272-6635 Monday – Friday, 7 a.m. - 7 p.m. CST
 Email: COVIDVaccineSupport@McKesson.com (only send email if after hours)

Moderna ancillary kit has a problem McKesson Specialty
 Phone: 1-833-343-2703
 Email: COVIDVaccineSupport@McKesson.com
Temperature excursions within the Clinic/Site  Phone: 1-866-MODERNA or 1-866-663-3762
 Email: excursions@modernatx.com
A complex COVID-19 vaccine safety question about an individual patient residing in the United States not readily addressed by CDC guidance

Healthcare personnel or health departments in the United States can request a consultation from
 The Clinical Immunization Safety Assessment COVIDvax project.
 Phone: 1-800-CDC-INFO (800-232-4636)

Pfizer-BioNTech

 Contraindications

Do not administer the vaccine to people with known history of a severe allergic reaction (for example, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine. Ingredients of the Pfizer-BioNTech COVID-19 Vaccine can be found on page 2 of the Pfizer EUA fact sheet.

 Clinical Resources

 Make sure you and your coworkers or staff are familiar with the updated EUA fact sheet for vaccination providers and give each vaccine recipient the EUA fact sheet for patients (in lieu of a vaccine information statement). You can find the reissued letter of authorization, translations of the fact sheet for recipients, and updated frequently asked questions on the FDA's webpage about its emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine.

 Review CDC's Pfizer-BioNTech COVID-19 Vaccine webpage for instructions on how to administer, store, and handle the vaccine.

 Check out CDC's resources for Pfizer-BioNTech COVID-19 vaccine, also available on the above webpage:

 

Administration

 McKesson updated their ancillary supply kit information to clarify the Contents and Quantities for Mega Kits to Support Pfizer Vaccine.

 (Added 03/02/21)

FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

On February 25, 2021, the FDA announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF).

Pfizer Inc. submitted data to the FDA to demonstrate that their COVID-19 vaccine remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature. The alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution (which can be held in the refrigerator for up to 5 days), or on the storage of thawed vials after dilution (which can be held at refrigerator temperature or room temperature for use within 6 hours).

Undiluted vials maybe stored at the following temperature ranges:

  • Between -80°C and -60°C until the expiration date
  • Between -25°C and -15°C for up to two weeks
    • Note: These temperatures are within the appropriate range for routinely recommended vaccines, BUT the temperature range for this vaccine is tighter. If storing the vaccine in a freezer with routinely recommended vaccines, carefully adjust the freezer temperature to the correct temperature range for this vaccine.
  • Between 2°C and 8°C for up to 120 hours (5 days)

Please note: The Pfizer thermal shipping containers cannot be used to store vials at -20oC. These shippers are to be used for dry ice storage only.

For additional information on Pfizer-BioNTech cold storage see the updated EUA Fact Sheet for Healthcare Providers Administering Vaccine. Pfizer also provides “on-demand” training, factsheets, and other resources at https://www.cvdvaccine-us.com/resources.

(Updated 02/23/2021)

Updated Pfizer Doses per Vial 

As of February 22nd, Pfizer’s COVID-19 vaccine vials are considered 6-dose vials. Vaccine received the week of February 22nd and after reflect the 6 doses per vial in your WIR inventory.

The ancillary kits for the Pfizer vaccine have been updated to include supplies to increase the likelihood of being able to draw up the 6th dose. This change has already been implemented and no action is required of providers. See below for an update about syringes for the sixth dose.

If the 6th dose is not obtained after February 22nd, you will need to report this dose as “wasted” in WIR and on the Wasted Vaccine Record (FORM #02768).

  1. WIR: Vaccinators must report vaccine wastage in WIR as soon as possible and within 24 hours of identifying the vaccine wastage (see WIR training for detailed instructions). In brief, to report wastage in WIR navigate to your inventory site in WIR. Select the appropriate vaccine/lot with wastage. Update the inventory to reflect the amount of doses wasted and indicate the reason why as, “doses wasted.”
  2. Wasted Vaccine Record (FORM #02768): Use this form to record and report vaccine that is disposed of according to your clinic guidelines for disposal of biologics. You will need to state the number of doses that were wasted and why and email the form to DHSCOVIDVACCINATOR@dhs.wisconsin.gov on a weekly basis. If more than 50 doses are wasted, please submit the form as quickly as possible.
    • On this form, if the sixth dose was available but unable to be used, providers should use the appropriate reason code to indicate for the scenario (e.g., the syringe was lost, broken, or not administered). If the provider was unable to access or draw down a sixth dose from the vial, providers should use the reason code 13 – Other and include in the explanation field on the form that the dosage was not available in the vial.

(Added 03/02/21)

Syringes for Pfizer Sixth Dose

As of February 22, DHS has implemented the necessary changes to reflect that the Pfizer vials contain six doses. Per CDC’s Emergency Use Authorization Fact Sheet, after dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution a vial contains 5 doses of 0.3 mL. The original guidance stated this was best accessed using a 3:3 ratio of low dead-volume (LDV) syringes to non-LDV syringes.

CDC has reassessed this guidance and the syringes currently available on the market. The new guidance showing a 5:1 ratio of low dead volume (LDV) syringes to non-LDV syringes is needed to ensure the availability of the sixth dose.

Moving forward, the Pfizer ancillary kits are supplied to support this new guidance. The syringes in the ancillary kit with the 1 inch needle (attached or separate) are LDV syringes and the 1.5 inch needle/syringe combination (attached or separate) are NOT considered LDV syringes.

Given this information, providers should draw up doses from each vial using five 1 inch needles/syringes and one 1.5 inch needle/syringe. Please keep in mind this guidance does not replace the need to use the correct needle size for intramuscular (IM) injection based on the individual.


See Pfizer's COVID-19 vaccine website or CDC's website for more information and resources specific to Pfizer’s vaccine, including resources to assist providers in storing, handling, and administering the vaccine.

 The FDA has launched a webpage with frequently asked questions about the Pfizer-BioNTech COVID-19 vaccine.

Contacts to help with addressing problems
I need help with… Contact…
Medical Information Pfizer Medical Service
 Phone: 1-800-438-1985
 Website: www.pfizermedicalinformation.com/
General Product Inquiries Pfizer Medical and Customer Service
 Phone: 1-877-829-2619
Pfizer vaccine shipment has a problem Pfizer Customer Service
 Phone: 1-800-666-7248
 Email: cvgovernment@pfizer.com
Pfizer ancillary kit has a problem

Contact McKesson MedSurg to report
 Email: SNSSupport@McKesson.com

Temperature excursions within the Clinic/Site  Phone: 1-800-666-7248
 Email: cvgovernment@pfizer.com
A complex COVID-19 vaccine safety question about an individual patient residing in the United States not readily addressed by CDC guidance

Healthcare personnel or health departments in the United States can request a consultation from
 The Clinical Immunization Safety Assessment COVIDvax project.
 Phone: 1-800-CDC-INFO (800-232-4636)

Johnson & Johnson

On Saturday, February 27, 2021, The Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the Johnson & Johnson vaccine product, also known as Janssen. On Sunday, February 28, 2021, the CDC's Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for the use of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older. Learn more about the evidence that went into ACIP's recommendation for Moderna's EUA. As more evidence becomes available, updates to recommendations or clinical considerations will be posted on the ACIP website.

Johnson & Johnson’s COVID-19 vaccine is:

  • A single-dose, viral vector COVID-19 vaccine.
  • Transported and stored at refrigerated temperatures (2 to 8 degrees C).
  • Authorized for people 18 years of age and older for the prevention of COVID-19 infection.
  • Administered intramuscularly.
 Contraindications

Do not administer the Johnson & Johnson COVID-19 vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Johnson & Johnson COVID-19 vaccine (see the full EUA Prescribing Information).

 
 Clinical Resources

 Prior to starting vaccine administration, ensure that your staff are familiar with the EUA fact sheet for clinicians. The patient fact sheet must be given to the patient or their caregiver in lieu of a vaccine information statement. Find frequently asked questions and more information on the FDA's webpage about its emergency use authorization of the Janssen COVID-19 Vaccine.

 Ensure your clinicians are familiar with the Morbidity and Mortality Weekly Report (MMWR), outlining ACIP’s vaccine interim recommendations for use of Johnson and Johnson COVID-19 vaccine.

 Johnson & Johnson's health care provider webpage has training webinars, storage, dosage, administration, and more resources.

 Review CDC's new Janssen COVID-19 Vaccine webpage for instructions on how to store, prepare, and administer the vaccine. Standing orders and other necessary resources will be uploaded here.

Expiration Date Guidance:

The expiration date is NOT printed on the vaccine vial or carton. To determine the expiration date:

  • Scan the QR code located on the outer carton, or
  • Call 1-800-565-4008, or
  • Go to www.vaxcheck.jnj.

Write date on carton. As the expiration date approaches, check the expiration date again. Use CDC's Vaccine Expiration Date Tracking Tool to document expiration date changes. For more guidance visit the Janssen COVID-19 Vaccine website.

 CDC's Storage and Handling Resources

 Johnson & Johnson (Janssen) Stability and Temperature Excursion Tool to help you see what to do with vials that may have experienced a temperature excursion.

Contacts to help with addressing problems
I need help with… Contact…
J&J/Janssen vaccine shipment had a temperature excursion during shipment)

Questions/concerns about vaccine viability issues (temperature excursions) during shipment must be reported on the same day as delivery.

 Phone: 1-833-272-6635 Monday – Friday, 7 a.m. - 7 p.m. CST
 Email: COVIDVaccineSupport@McKesson.com (only send email if after hours)

J&J/Janssen vaccine shipment has a problem  Phone: 800-565-4008 or 1-908-455-9922  
 Email: JSCCovidTempExcursion@its.jnj.com
J&J/Janssen ancillary kit has a problem McKesson Specialty
 Phone: 1-833-343-2703
 Email: CovidVaccineSupport@McKesson.com
Temperature excursions within the Clinic/Site  Phone: 800-565-4008 or 1-908-455-9922  
 Email: JSCCovidTempExcursion@its.jnj.com
A complex COVID-19 vaccine safety question about an individual patient residing in the United States not readily addressed by CDC guidance

Healthcare personnel or health departments in the United States can request a consultation from
 The Clinical Immunization Safety Assessment COVIDvax project.
 Phone: 1-800-CDC-INFO (800-232-4636)

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 Vaccine Safety

Ensuring the safety of all vaccines, including the COVID-19 vaccine, is a top priority for both DHS and the CDC. The U.S., we have several systems in place to monitor the safety of COVID-19 vaccines. You are a part of this vaccine safety system! Make sure you know about the different parts of our vaccine safety system and know how you can report to it!

 Make sure you and your coworkers or staff are familiar with the EUA fact sheet for vaccination providers and give each vaccine recipient the EUA fact sheet for patients. The patient fact sheet is given in lieu of a vaccine information statement. You can find these fact sheets and more on the FDA's product-specific webpages about emergency use authorization of COVID-19 vaccines.

 Review What Every Clinician Should Know about COVID-19 Vaccine Safety.

 Ensure all of your patients are aware of and receive a QR code for the v-safe program.

 V-safe is a new smartphone-based tool that provides personalized health check-ins and easy reporting of side effects for people who receive a COVID-19 vaccine. It can also remind people to get their second COVID-19 dose! Anyone who reports a medically significant (important) adverse events on V-safe, will get a follow-up phone call from CDC. As part of the COVID-19 Vaccine Program enrollment process, providers were sent a patient handout that includes a QR code. We ask that providers encourage patients to download and participate in v-safe after receiving a COVID-19 vaccine.

 

 It is a requirement that you submit all vaccine administration errors and adverse events to VAERS. Be sure to familiarize yourself with the specific EUA reporting requirements including:

  • Vaccine administration errors whether or not associated with an adverse event
  • Serious adverse events (irrespective of attribution to vaccination)
  • Cases of Multisystem Inflammatory Syndrome (MIS) in adults
  • Cases of COVID-19 that result in hospitalization or death.

 The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program that has been used to detect possible safety issues with vaccines for many decades. Anyone can, but medical providers must, report adverse events (possible side effects or health problems) that occur after vaccination using VAERS.

 

 Healthcare personnel or health departments in the United States can request a consultation from the Clinical Immunization Safety Assessment (CISA) COVIDvax project for a complex COVID-19 vaccine safety question about an individual patient residing in the United States not readily addressed by CDC guidance.

Request a consultation from CISA by:

Calling 800-CDC-INFO (800-232-4636)

Submitting a request via a form

 

 Read more about adverse events, and local and system reactions to Moderna and Pfizer-BioNTech COVID-19 vaccines.

Email us if you have more questions about vaccine administration or safety.

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 COVID-19 Vaccinator Enrollment

Click on a tab below to see either the Steps to Enroll or frequently asked questions and answers about enrollment.

Steps to Enroll (03/01/2021)

(Updated 03/01/2021 to highlight the provider registration scenarios that help while filling out required Form B and Redistribution Forms.)

Background

The Wisconsin COVID-19 Vaccine program is enrolling entities that wish to vaccinate. By enrolling in the program, entities and their vaccinators will be approved to administer COVID-19 vaccine in Wisconsin. To become a COVID-19 Vaccinator, all organizations must have an approved Form A and Form B. To redistribute vaccine, all enrolled COVID-19 vaccinators must also have an approved Redistribution Form.

Steps to complete enrollment and redistribution forms

It is important that you complete every step in the enrollment process in order to ensure your submission is processed as quickly as possible. Please use Google Chrome when navigating the enrollment tool. Email us if you have any questions!

Step 1: Log in to the COVID-19 Vaccine Enrollment Tool using your Department of Administration (DOA)/Wisconsin Logon Management System username and password.

  • If you do not have a DOA/Wisconsin Logon, please register here.
    • Select Self-Registration. After you accept the user agreement and fill in your personal profile information, select “DHS Health Reports” under “Systems You Will Access.”
    • After your registration is complete, proceed to the enrollment tool.
  • If you have a DOA/Wisconsin Logon, then proceed to the enrollment tool and logon using your DOA/Wisconsin Logon username and password.

Step 2: Generate your forms.

USE CAUTION: Once information is entered and site type is chosen, you may NOT go back to change them.

  • Enter information into the COVID-19 Vaccine Enrollment Tool.
  • Scroll to the bottom of the page and select “Generate Forms”, which will generate forms specifically for your organization.
    • Your organization name and a reference number will be pre-populated on the forms (located at the bottom of each generated form).
    • You can have your vaccine sites use this information to ensure they are using your organization-specific forms.

Step 3: Complete and sign your forms. (Updated 03/01/21)

Note: All signatures must be present on a form before submission. Instruction is provided within the forms by hovering over the blue bars in the form.

  • Each unique legal organization must complete a Form A.
  • If your organization may need to move vaccine to another organization, or to another Form B location within your own organization, you must complete a Redistribution Form. This form should match your organization’s Form A in the following fields:
    • Organization Name
    • Medical Director/Chief Medical Officer
    • Chief Executive Officer (CEO) or Chief Financial Officer (CFO)
  • Complete a Form B for each physical address where you will store or administer COVID-19 vaccine, with certain exceptions. Please see these provider registration scenarios to see what forms are required for different vaccination clinics. If you have questions about whether your organization requires additional Form B submissions, please email us.

Step 4: Submit all your forms.

Note: You may submit your organization's forms from any DOA/Wisconsin Logon Management System login. Only submit the completed forms that were specifically generated for your organization with the reference number in step 2 above (this is listed at the bottom right of your generated forms).

  • Find “Submit Forms” at the top left of your web browser.
  • Upload your completed and signed forms to their corresponding fields. DON’T FORGET TO HAVE YOUR FORMS SIGNED AND DATED!
  • Scroll to the bottom of the page and select the “Upload Files” button.
  • If you need to change your information after submitting do so via the Wisconsin Immunization Registry. Any information that needs to be changed outside of WIR can be done by contacting dhscovidvaccinator@wi.gov.

Step 5: At various different stages of registration, staff may contact you to ask questions about your submission, correct errors, or provide instructions on next steps. Please respond to this outreach immediately so that we can continue processing your registration. This step may occur after your organization has been approved to receive vaccine.

Step 6Once your information is verified and your WIR account is configured, the primary contact listed on the Form B will receive an email from DHS with next steps for your organization.

 Your vaccine coordinator, back-up coordinator, and other relevant staff must complete the required Wisconsin Immunization Registry (WIR) and vaccine storage and handling trainings. These training videos do not use Adobe Flash Player. You will be emailed a survey to attest that your staff have completed the WIR and the Storage and Handling trainings. Your organization will not be able to order COVID-19 vaccine unless these trainings are completed and acknowledged within 5 days of receipt of the email with the attestation survey.
 We also highly recommend your staff takes the CDC's Just in Time trainings for Pfizer-BioNTech and Moderna vaccines! See the Trainings section below for additional trainings.

 

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Enrollment Q&A (03/01/2021)

(Updated 03/01/2021 to highlight the provider registration scenarios that help while filling out required Form B and Redistribution Forms.)

 General enrollment questions

Q: How do I enroll?

A: Please follow the steps outlined in the Steps to Enroll tab above. Once you generate your forms in the enrollment tool, there is hover text with additional details located in the blue bars of your forms. When you hover your mouse over some of the blue section bars, text boxes will pop up with further instructions.

Q: Should I enroll in the COVID-19 Vaccine program if my organization is already a Vaccines for Children (VFC) and/or Vaccines for Adults (VFA) provider?

A: Yes you need to enroll. This is a new program and all providers need to sign the CDC COVID-19 Vaccine agreement regardless of VFC/VFA status.

Q: Do pharmacies that are partnering with LTC through the LTC Pharmacy Partnership need to enroll in the Wisconsin COVID-19 program, too?

A: Yes. Please see our webpage for the LTC Pharmacy Partnership for more details.

Q: Is there a certain web browser I must use for the enrollment tool?

A: Yes, please use Google Chrome. Do not use Internet Explorer or Microsoft Edge. If you do submit your forms in the wrong browser you may get an error. If this happens, please regenerate the forms and resubmit them in another browser.

Q: Where can I find additional instructions to complete the enrollment forms?

A: Additional instructions are provided as hover text over the blue bars within each of the forms. When you hover your mouse over some of the blue section bars, text boxes will pop up with further instructions.

We are also working on a video series for further instructions to assist with enrollment. We will post it here, so stay tuned.

Q: I see that the deadline for enrolling as a Phase 1A provider has past. Can I still enroll to provide vaccine in the subsequent phases?

A: Yes, please enroll to provide vaccine in the subsequent phases. However, there may be deadlines to have provider forms submitted for each phase of the vaccine rollout. Please watch for these deadlines if you plan to vaccinate in certain populations that are recommended in subsequent phases.

Q: How do I electronically sign my agreement?

  • Use Google Chrome to download the forms.
  • Save the forms to your desktop.
  • Complete your forms in the updated version of Adobe (not in a web browser such as Internet Explorer). If you use an earlier version it will let you sign and complete your form, but the PDF produced from it may be too large to be accepted by the enrollment tool.
  • Follow the instructions found in the enrollment tool to upload your forms and complete your signature.

Q: How do I know what the next steps are after I submit the enrollment forms?

A: If there are no follow-up questions from the DHS enrollment team, we will verify your forms. Once verified, our team will email you with next steps in the process.

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 Questions about filling out the forms (Updated 03/01/2021)

Q: How many Form A's need to be submitted?

A: Only one Form A needs to be submitted for the entire organization.

Q: Which sites in my organization need to fill out the Form B? (Updated 03/01/2021)

A: Complete one Form B for each site that will be administering COVID-19 vaccine.

  • If vaccine is being taken to an off-site clinic two consecutive days or more, then a Form B is needed.
  • If vaccine is taken more than once to an off-site clinic, then a Form B is needed.
  • If vaccine is taken to an off-site clinic only one day, then no Form B is needed.

Examples:

  • If an off-site clinic is planned Monday and Friday, then a Form B is needed for the off-site clinic.
  • If an off-site clinic is planned for Monday and Tuesday (two consecutive days), then a Form B is needed for the off-site clinic.
  • If an off-site mass vaccination clinic is planned by a site for just Monday, no Form B is needed for that off-site clinic.

Please see these provider registration scenarios to see whether an additional Form B is required for a vaccination clinic. (Updated 03/01/2021)

Q: Is there a limit to how many Form B’s can be filled out for every Form A?

A: No, there is no limit.

Q: What if a location has more than 25 providers to list on its Provider Agreement?

A: If a Form B location has more than 25 providers, an additional Form B will need to be submitted. For the additional Form B’s, please include the exact location name as listed on the first Form B, a signature and date, and the additional provider information. All of the forms will need to have the same reference number listed at the bottom of their pages.

Q: What if sites begin submitting Form B’s before the organization’s Form A is submitted?

A: Form B’s will not be registered until the corresponding Form A is verified. Once both sections are submitted and verified, an organization and sites will be registered.

Q: Which providers should be included on my Form B?

A: Any provider with prescribing authority that will be administering the COVID-19 vaccine or overseeing its administration (MD, DO, NP, DPM, PA, RPh, etc.) should be included on your Form B’s. Please do not list providers who will be immunizing without prescribing authority (EMT, RN, LPN, Paramedic, etc.).

Q: If additional sites are identified after my original submission, can I submit additional Form B’s at a later date?

A: Yes, please make sure your organization name and reference number on the new Form B’s match your originally submitted forms.

Q: What if I don’t know my IIS identifier?

A: Please include either:

WIR Organization ID Identifier

  • Your Wisconsin Immunization Registry (WIR) Org ID. If you do not know your WIR Org ID, you can use the following steps to find your WIR Org ID, if you have one.
  1. Find a staff member from your organization that has access to WIR as an IR Administrator. Any of staff member that is an IR Administrator can find your WIR Org ID by following these steps.
  2. Navigate to manage access and select Edit Organization.
  3. From the list of organizations click the link for the correct location.
  4. The Edit Organization page loads.
  5. You will find a number next to the Org Id. This number is also your IIS Identifier.
  • If you cannot find or do not have your WIR Org ID, you can use your VFC PIN.
  • If you do not have a WIR Org ID nor a VFC PIN, then please submit your forms without them.

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 Questions about Redistribution Forms (Updated 03/01/2021)

Q: What is redistribution?

A: Redistribution is the process by which COVID-19 vaccine is physically transported to a new location and the responsibility of that vaccine is transferred from the provider that initially received the vaccine shipment to another provider. This health care provider at the new location is responsible to store and administer the vaccine.

Q: Where can I find the Redistribution Form?

A: The Redistribution Form may be found on the provider enrollment tool with the other provider agreement section A and B forms.

Q: Who are the responsible officers on the Redistribution Form?

A: These are the CMO or equivalent and CEO/CFO found on your Form A. They will be listed as Medical Director or equivalent and CEO/CFO on your Redistribution Form. These contacts must be the same for both forms.

Q: Do I need a Redistribution Form? (Updated 03/01/2021)

A: Providers are required by the CDC to have an approved Redistribution Form if they intend to transfer vaccine from their enrolled COVID-19 location to another enrolled location.

The Redistribution Form serves as an agreement from the provider to comply with all COVID-19 vaccine redistribution agreement requirements. Please see these provider registration scenarios to see whether a Redistribution Form is required in your case. (Updated 03/01/2021)

Q: Do I need to have an approved COVID-19 Vaccine Provider Agreement to redistribute vaccine?

A: Yes, in order to redistribute vaccine, you must have an approved provider agreement on file (section A and B forms).

Q: Does the reference number on the Redistribution Form need to match my other paperwork?

A: Yes, in order to expedite processing of your paperwork and ensure all paperwork is connected in the database, the Redistribution Form should have the same reference number as your section A and B form.

If they are not the same reference numbers, or you do not know your Form A/B reference number, contact us at DHSCOVIDVACCINATOR@dhs.wisconsin.gov.

Q: Am I allowed to redistribute vaccine to a clinic or location that is not enrolled?

A: No, CDC requires all entities that are to administer COVID-19 vaccine to be enrolled. Providers who redistribute vaccine to non-enrolled organizations are in violation of their signed agreements and may not receive future allocations of vaccine due to noncompliance.

Q: What do I do if I need to redistribute vaccine immediately?

A: DHS is unable to guarantee expedited processing of Redistribution Forms. If you have additional vaccine that you cannot use, you must contact your Regional Manager. Providers who anticipate that they may need to redistribute vaccine in the future are encouraged to proactively submit a Redistribution Form.

Q: Do I need to receive approval before I can redistribute vaccine? 

A: Yes, providers are not allowed to redistribute vaccine until they have received e-mail approval from DHS.

Q: What if I already completed a Redistribution Form?

A: If you have already submitted a redistribution Form B but have not received your e-mailed approval, contact the DHSCOVIDVACCINATOR@dhs.wisconsin.gov regarding the status of your form.

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 Questions about correcting and submitting forms

Q: I have signed the forms incorrectly and when I submitted it, I got an error. I fixed the signature (per the Signature Instructions), and the enrollment tool still will not accept my forms. What should be done?

A: Unfortunately you will need to generate a new version of the forms, refill it out, sign it correctly, and then resubmit it to the enrollment tool.

Q: What if I need to update information on the forms?

A: Please submit an email request to change information to your forms to dhscovidvaccinator@wi.gov. You must include the location or organization name listed on your original forms in the subject line. Then include what information you need changed in the body of the email.

Q: When will I know if my forms were submitted correctly?

A: After your forms have been submitted, you should receive a confirmation screen which will indicate that your forms have been submitted correctly.

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 Questions about training

For more information about the Wisconsin Immunization Registry (WIR), visit their website or contact the WIR Help Desk by phone 608-266-9691 or email.

Q: Who needs to do the WIR training?

A: With having access to WIR data and ensuring timely and accurate information, comes the need for a solid understanding of how to utilize the various components of WIR and how they work together. Any staff responsible for data entry into WIR for the daily management of inventory and/or updating client (patient) records to record the administered dose are required to review the training material. Staff that are only administering vaccine and won’t be responsible for the data entry and management don’t need to be concerned with the training.

Q: What does the WIR training entail?

A: WIR training includes the following topics:

  • Client look up and entry of doses, including mass vaccination module
  • Inventory management, including reporting daily inventory
  • Use of bar code scanner
  • Transferring doses
  • Reporting wasted doses

Q: What do I do if I can't access the WIR training related to COVID-19 enrollment?

A: Staff with existing IR Administrator access should be able to use the ‘Assign Training’ tool to provide their staff with the training modules.

If you are using a web browser other than Internet Explorer (IE) you may encounter issues with this.

Q: How do I assign trainings to users?

A: If you are using Internet Explorer and are still encountering issues, take the following steps.

1. Click on the gear (   ) icon or the Tools menu in Internet Explorer.

Gear and Compatibility View Setting

Tools Compatibility View Settings

2. Select Compatibility View Settings and add dhswir.org and dhfswir.org to the list of websites.

3. Ensure the following websites are listed: dhswir.org and dhfswir.org.

Change Compatibility Settings dhfswir and dhswir

4. If they aren't, type the websites in the Add this website box and click Add. Then click Close.

Q: Do I have to have a specific level of access to review the WIR training and perform the necessary tasks within WIR?

A: No, the ability to review the WIR trainings and, most importantly, to perform the necessary tasks within WIR DOES NOT require any 1 specific role (level of access). If your staff already have WIR access, you likely will not need to change that access. Staff who have WIR access with any of the following roles, may be left unchanged if you so desire.

  • IR Administrator
  • IR Inventory Control
  • IR Typical User
  • IR Mass Vaccination
  • IR MV + Inventory

Note: You will need to consider the responsibilities of each staff member in your COVID-19 vaccination operations. With that in mind, you may find it necessary to increase the level of access, to ensure they can perform the necessary actions in WIR.

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 Trainings (Updated 04/06/21)

Required COVID-19 Vaccine Trainings

Anyone who will handle and/or administer COVID-19 vaccine must be well trained on the basic principles of vaccination and vaccine-product specific information for vaccine handling and administration. The following trainings are required for every vaccinator receiving and/or administering COVID-19 vaccine through the Wisconsin Department of Health Services.

General COVID-19 Vaccine Training Modules

Pfizer Training Modules

Moderna Training Modules

Janssen Training Modules

 

Recommended and Supplemental Trainings

New vaccinators may need additional trainings or to review additional resources to feel comfortable providing the COVID-19 vaccine. The following are recommended for new vaccinators and can be used by experienced vaccinators as a review.

 

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 Communication Resources (Updated 03/30/21)

As one of the most trusted sources of medical information, you play a critical role in helping build confidence in COVID-19 vaccination with your clients. An important part of preparing for a safe and effective COVID-19 vaccine is sharing information about the vaccine.

 Young adult being inoculated at a vaccine clinic

 We encourage you to share the resources and information the CDC has developed around COVID-19 vaccine planning, recommendations, and safety monitoring. You can also share CDC's list of 10 things health care professionals need to know about COVID-19 vaccination plans with your coworkers and staff.

 Learn how to make a strong recommendation for COVID-19 vaccination, talk to patients about COVID-19 vaccines, answer patients' questions, and explain how mRNA COVID-19 vaccines work on CDC's COVID-19 vaccination website for health care professionals. Or go more in depth with CDC's reference materials to learn how you can communicate with patients about vaccines to foster a culture of immunization.

 We know that your staff and patients may have many questions about the COVID-19 vaccine. Find answers to many frequently asked questions on the Children's Hospital of Philadelphia's thorough COVID-19 Vaccine Education Center website or in CDC’s COVID-19 Vaccination Toolkits' many FAQs.

DHS Materials

 Our DHS COVID-19 vaccine message map contains the main communication messages we want health care professional to know. Feel free to use these to craft messages that meet your clients' needs.

 Post these materials on your social media, upload them on your webpages, or give patients physical copies when they come in!

 To request physical, printed copies of these or other DHS COVID-19 materials, please follow these instructions.

Almost all the following resources are available in Hindi, Hmong, Somali, Chinese (Mandarin) and Spanish.

COVID-19 Vaccine, Who is Eligible in Wisconsin? P-02902Who is Eligible in Wisconsin?
This describes who is currently eligible and who will be eligible next.

COVID-19 Vaccination A Phased Approach, P-02901COVID-19 Vaccination: A Phased Approach
This describes how and why the vaccine is being rolled out in phases. 

 

Getting a COVID-19 Vaccine, P-02891Social Story: Getting a COVID-19 Vaccine (Updated 03/15/21)
Social stories use pictures and simple language to help people understand certain situations and challenges and how people can deal with them. Also in ASL Video format.

Next Steps: After you receive the COVID-19 vaccine, P02879Next Steps: After you receive the COVID-19 Vaccine
Our fact sheet and website explain next steps after you get your first or second dose of COVID-19 vaccine.

 

COVID-19 Vaccine Allocation ProcessCOVID-19 Vaccine Allocation Process Image
This new image explains the vaccine allocation process from the federal government to COVID-19 vaccination. Download this as a PDF or JPG file.

Infographic for the vaccine lifecycleVaccine Life Cycle Phases Image
Educate people about the journey vaccines take to get created and approved. Download our new image as a PDF or PNG file. (Only in English).

 

COVID-19 Vaccine Safety P02872COVID-19 Vaccine Safety Fact Sheet
Share our new fact sheet about vaccine development, emergency use authorization, and safety monitoring with your patients and coworkers.

Coronavirus Disease 2019 publication P02592General COVID-19 Fact Sheet
This fact sheet provides an overview of how COVID-19 is spread, the signs and symptoms, quarantining, and how to prevent the disease.

 

Division of Medicaid Services (DMS)
Vaccine Information Sheets for:
Children in CLTS and other Disability programs are at higher risk of getting sick from COVID-19 IRIS
Children's Long-Term Care (CLTS)
Family Care
(Added 02/05/2021)

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CDC Materials and Resources

 
How Viral Vector COVID-19 Vaccines Work Infographic
Give your patients this fact sheets to help them learn more about how the vaccines work. It is available in English and Spanish.
 
How mRNA COVID-19 Vaccines Work Infographic
Give your patients this fact sheets to help them learn more about how the vaccines work. It is available in English and Spanish.
 
 
What to Expect at your Vaccination Appointment
Did someone schedule a COVID-19 vaccine appointment? Send them CDC this website or plain language fact sheet so they know what to expect.
 
What to Expect after a COVID-19 Vaccination
Give your patients this CDC website or handout about common side effects and helpful tips after COVID-19 vaccination.
 
 
Updated COVID-19 Vaccine Homepage
This webpage has easy to read FAQs, information about what to expect before and after COVID-19 vaccination, and resources for health care workers.
 
V-safe Handouts
These handouts help your patients download and navigate the v-safe app for personalized health check-ins and easy reporting of side effects after vaccination.
 

COVID-19 Vaccination Communication Toolkits 

(Updated 02/23/21 with new printable resources, stickers, and graphics)

Share, use, or adapt CDC's ready-made materials to build confidence about COVID-19 vaccination. These include social media messages and images, resources for talking with staff, residents, and families, FAQs on the vaccines, and tips on how to prepare staff. Check out CDC's COVID-19 Vaccination Communication Toolkits for:

  • Medical Centers, Clinics, Pharmacies, and Clinicians
  • Healthcare Professionals and Pharmacists
  • LTCF Administrators and Leadership
  • Employers of Essential Workers
  • Staff of Organizations Serving Communities
 

 

Other Resources

 
COVID-19 Vaccine Toolkit (Added 02/05/2021)
This in-depth guide from the American Lung Association and the Center for Black Health & Equity shares information to help explore concerns, answer questions, and start conversations about the COVID-19 vaccine. It has
  • social media shareables,
  • information on Operation Warp Speed and the clinical trials,
  • and a joint statement from HBCUs!
 
Social Media Graphics
 
 
COVID-19 Vaccine Information Videos for Refugees 
Milwaukee's Refugee Community Advisory Board's videos are available in multiple languages. You can use the following scripts to create videos in your communities: Vaccine Safety, Vaccine Side Effects, Vaccine Information and Side Effects. (Added 02/05/2021)
 
Printable Q&A about COVID-19 mRNA Vaccines
Give or send your patients this printable Q&A from the Children's Hospital of Philadelphia.
 

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 Frequently Asked Questions (Updated 4/13/21)

 For questions about enrollment and training, please see the Q&A tab of the Enrollment section above.

 For information and frequently asked questions about the Pharmacy Partnership for Long-Term Care Program, check out our website for the LTC Pharmacy Partnership and the CDC website.

 

 General Questions

Q: To avoid the need to touch and hand out vaccination cards on site, can we email, text, or electronically provide the vaccination card to the patient and still be in compliance with CDC requirements?

A: Yes, you can give your patients a vaccination card electronically.

Q: Can organizations require people to get a COVID-19 vaccine authorized under an Emergency Use Authorization (EUA)?

A: The EUA does not contain any wording that prohibits making an EAU-approved vaccine mandatory. However, the FDA website indicates that a person has the right to refuse an EUA product.

Recipients of a vaccine under an EUA must be informed of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, any available alternatives to the product, and that they have the option to accept or refuse the vaccine. Any person who gets an EUA-approved COVID-19 vaccine must receive the FDA fact sheet for vaccine recipients and caregivers that contains this information.

Q: What types of providers can vaccinate? (Added 03/22/21)

A: Providers should consult their governing laws and any policies or guidance issued by the regulatory program, board, or commission for their profession. Providers are responsible for complying with the standards of practice and any other legal requirements applicable to their profession when ordering or administering vaccines in the state of Wisconsin. Some professions may have limitations related to delegation, supervision, training, settings, etc. when ordering or administering vaccines. We encourage providers to contact their specific program, board or commission with any questions. Please refer to the State of Wisconsin Department of Safety and Professional Services for additional information.

 Questions about vaccine delivery and redistribution (Updated 4/13/21)

Note: questions and answers about vaccine administration have been moved to the Vaccine Guidance section below.

Q: What are any restrictions that are in place for the delivery window to receive vaccine?

A: There are several. You will need to have your staff who are trained on vaccine storage and handling onsite to receive vaccine. You will also need to have a window that complies with the rules listed below:

  • There needs to be two (2) delivery windows, one morning and one afternoon (for selected days).
  • You must have a one-hour spacing, between the morning (first) and afternoon (second) delivery windows:
    • 7:00 a.m. – 12:00 p.m.
    • 1:00 – 4:00 p.m.
  • If you are selecting Monday as a delivery day, you must also have at least one delivery window of four or more consecutive hours on a weekday other than Monday.

Q: How will my organizations be able to redistribute the COVID-19 vaccine?

A: Redistribution should only occur on a limited basis. You must take every precaution to protect the viability of the vaccine while it is being transported.

You will need to email dhscovidvaccinator@dhs.wisconsin.gov to have the redistribution form emailed to you along with instructions for completion. Reply back to the email to return the redistribution form.

This agreement is similar to the section A form you already completed. You will need to have your chief medical officer (or equivalent) and chief executive officer (or chief fiduciary) complete and sign this agreement. The person who signs this should be the same person who signed the section A form for your organization.

Please be aware, your organization will only be able to redistribute COVID-19 vaccine to a provider location that has completed a section B form and successfully registered with the Wisconsin COVID-19 vaccination program. Some of the COVID-19 vaccine products have stringent storage and handling requirements and, therefore, redistribution should be limited.

Q: Are there restrictions on when COVID-19 vaccine can be delivered to sites?

A: Yes, your sites must indicate they can receive vaccine delivery, at minimum:

  • One day per week other than a Monday.
  • A delivery window of four consecutive hours that does not encompass the noon hour.

Q: How do I report issues with equipment in the ancillary kits that are shipped with our federal vaccine orders? (Added 4/13/21)

A: There are three steps to reporting to ensure enough information is gathered so problem trends in packaging and shipping can be identified

  1. Report deficiencies to DHS and clinic/hospital leadership. This helps identify trends in problem equipment.
  2. If an error or injury occurs during vaccine administration, enter the information into Vaccine Adverse Event Reporting System (VAERS).
  3. Because syringes are a medical device, complete FDA form 3500.

For ancillary kits for Pfizer vaccine only, you should also report deficiencies to McKesson via email SNSSupport@McKesson.com.

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 Questions about billing information

Q: Can we bill the patient for COVID-19 vaccination?

A: CDC has provided guidance that patients should incur NO out-of-pocket costs for COVID-19 vaccination. The updated language from the CDC’s provider enrollment forms is as follows:

Organization must administer COVID-19 vaccine regardless of the vaccine recipient’s ability to pay COVID-19 vaccine administration fees or coverage status. Organization may seek appropriate reimbursement from a program or plan that covers COVID-19 Vaccine administration fees for the vaccine recipient. Organization may not seek any reimbursement, including through balance billing, from the vaccine recipient.

Direct any questions you may have regarding billing or reimbursement of vaccine administration fees covered by private insurance or Medicaid to the respective insurance provider or Medicaid program.

Q: Will COVID-19 vaccine providers need to cover the costs of vaccination?

COVID-19 vaccine will be procured and distributed by the federal government at no cost to enrolled COVID-19 vaccination providers.

Providers can bill for an office visit when administering COVID-19 vaccine if the visit meets the criteria for office visit coding under a recipient’s plan. However, vaccine providers must administer COVID-19 vaccine regardless of the vaccine recipient’s insurance coverage status or their ability to pay COVID-19 vaccine administration fees, as stated in the CDC Provider Agreement.

Vaccine providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient. Those entities administering the COVID-19 vaccine to patients without insurance or whose plans will not cover the vaccine may request reimbursement for COVID-19 vaccine administration through the Health Resources and Services Administration (HRSA) Provider Relief Fund.

Q: What requirements or guidelines are there for vaccinating BadgerCare Plus and Medicaid members?

Wisconsin’s Medicaid program has released information about covered COVID-19 vaccines, claims submission, member cost sharing, reporting requirements, and reimbursement for when providers give the vaccine to BadgerCare Plus and Medicaid members. Find this information here.

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 Thank you for your continued work as we move to implement an important tool in the fight against COVID-19!

You can sign up for CDC email updates about COVID-19 vaccination to stay up-to-date. Visit CDC's COVID-19 Vaccination website and enter your email in the “Get Email Updates” box at the lower left-hand side of the page.

Last Revised: April 13, 2021