COVID-19: General Guidance for Vaccinators

On August 11, 2022, Centers for Disease Control and Prevention (CDC) announced it's streamlining its COVID-19 guidance to help people better understand their risk, how to protect themselves and others, what actions to take if exposed to COVID-19, and what actions to take if they are sick or test positive for the virus. DHS is currently reviewing CDC updates and will update our guidance accordingly.

Monthly webinars

Webinars for stakeholders and vaccinators are held the second Tuesday of every month from 11 a.m. to noon. The Zoom link for the webinar has not changed.

New attendees need to register for this webinar. Once you register, you can use the same Zoom link for every webinar.

Watch recordings of past webinars.

Four people showing their arm with band-aid after vaccinationVaccinators are the front line of defense to stopping the spread of COVID-19. This page has critical guidance and resources about COVID-19 vaccines for people ages 6 months and older, covering:

Vaccinators should also continue to monitor their emails for the most up-to-date information.

 

10 million doses of COVID-19 vaccine have been administered in Wisconsin

“Wisconsin’s vaccine providers have worked tirelessly these past few years, and we’ve been proud over the course of this pandemic to be a national leader in getting available shots in arms,” said Gov. Evers.

“This is a tremendous milestone, and we couldn’t have gotten here without the hard work and dedication of everyone involved. Whether you’re administering shots, scheduling appointments, answering phones, or sanitizing workstations – thank you.”

 
Updates
  • August 5, 2022:
    • The Wisconsin Immunization Registry (WIR) will be undergoing regular maintenance on its computer servers on Saturday, August 20, and Sunday, August 21 from 7 a.m. to 8 p.m. See the WIR highlights section for more information.
  • July 27, 2022:
  • July 19, 2022:
  • July 12, 2022:
    • Moderna COVID-19 6Y-11Y (dark blue cap, purple label border) vaccine is now available for ordering in Wisconsin. See the vaccine ordering amounts below. 
    • Webinars for stakeholders and vaccinators are now held on a monthly basis on the second Tuesday of every month from 11 a.m. to noon. The Zoom link for the webinar has not changed. Previous registrants can change the calendar dates for future webinars yourself and delete the dates that no longer apply; or you can re-register for the webinar series and cancel the previous webinar series.

 Vaccine administration guidance

Useful tools and resources:

Wisconsin Immunization Registry (WIR) highlights

WIR unavailable August 20-21 from 7 a.m. – 8 p.m.

WIR will be undergoing regular maintenance on its computer servers on Saturday, August 20, and Sunday, August 21. The work will take place both days between the hours of 7 a.m. and 8 p.m. During these timeframes, vaccinators will not be able to use WIR. 

DHS urges vaccinators to plan for WIR not being available during this timeframe and to make other arrangements, that will allow them to access immunization records, if possible. This will be especially important and have the most impact on vaccinators that are holding vaccination clinics during the weekend of August 20-21. 

 

Key WIR resources:

WIR training videos covering the following topics:
  • Managing sites
  • Managing clinicians
  • Managing transfers
  • Inventory management
  • Mass vaccination function
Webinar recordings with WIR information
Additional information and resources
Reminder/recall notices in WIR

Reminder/recall report functions assist providers with outreach to their patients. Providers can send reminder notices to clients who have an immunization due in the near future to remind them to call and schedule an appointment. Recall notices are used for those clients who are overdue for a vaccine and need to come in to bring their vaccination record up to date.

From the reports menu option in WIR, you may generate reminder and/or recall notices, which include letters, cards, address labels, client listings, and downloadable text files.

The reminder/recall report in WIR includes the following features that give you the ability to:

  • Report by individual vaccine group
    • Generate the report for only COVID-19 vaccines.
  • Report by trade name within selected vaccine group
    • Generate a report for individuals needing a particular manufacturer/trade name of vaccine (such as, Pfizer, Moderna, Novavax, or Johnson & Johnson).
  • Choose which dose in the series you want to run the report for
    • Create a report for those needing the second dose (such as, determining which patients still need to complete the series).
  • Export only one address per person
    • Previously, letters would be generated for all of the responsible people for each client. The new functionality allows for the option to generate only one letter for each client.

You can also review this information in a video about the WIR reminder recall/report feature.

Demographic data entry in WIR

While the completion of data entry for race and ethnicity variables is high (around 90%) in Wisconsin, this is due to continued efforts on the part of vaccinators each day as they collect and enter this information for all those they vaccinate. This critical data helps the Wisconsin Department of Health Services (DHS) and local and tribal health departments understand where disparities in vaccination rates are occurring and informs equitable vaccine distribution plans to address them. As such, it is imperative that vaccinators develop and adhere to clear processes for collecting and entering race and ethnicity data into WIR. To assist in this process, the mass vaccination module in WIR now collects race and ethnicity data when entering vaccines administered.

COVID-19 vaccine billing practices

General billing guidelines and requirements

The COVID-19 Vaccination Program’s primary goal is to administer COVID-19 vaccine safely, quickly, and equitably to all people across the state. In order to do this, it is critical that everyone have access to free COVID-19 vaccine. Anyone in Wisconsin can get vaccinated for free — even if they cannot provide proof of residency, do not have a valid state identification, or do not have insurance. Vaccinators cannot require people to provide an ID, cannot charge a co-payment, and cannot bill patients for charges not covered by insurance.

The COVID-19 vaccine is provided to Wisconsin by the Federal Government and therefore must be administered at no cost to all recipients. By signing the Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program Provider Agreement to receive and dispense vaccines, providers are committing to being accountable for the conditions specified in the agreement.

In addition to the terms specified in the Provider Agreement, all organizations and providers participating in the CDC COVID-19 Vaccination Program are expected to adhere to the following CDC guidelines. COVID-19 vaccine providers:

  • Must administer COVID-19 vaccine at no out-of-pocket cost to the recipient
  • May not deny anyone vaccination based on the vaccine recipient’s coverage status or network status
  • May not charge an office visit or other fee if COVID-19 vaccination is the sole medical service provided
  • May not require additional medical services to receive COVID-19 vaccination
  • May not seek any reimbursement, including through balance billing, from the vaccine recipient
  • May seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient, such as:
    • Vaccine recipient’s private insurance company
    • Medicare or Medicaid reimbursement

Vaccine providers who are using state resources, such as WING or AMI, to fully or partially support COVID-19 vaccination cannot bill patients or their insurance or receive payment from insurance for the administration of the COVID-19 vaccine.

 
DHS is collaborating with our federal and state partners to closely monitor provider program compliance and billing practices. This includes investigating all instances of inappropriate billing and fraud reported by Wisconsinites, conducting analyses of COVID-19 vaccine administration data, and initiating CDC-required on-site visits.

Getting paid for COVID-19 vaccine administration

Each COVID-19 vaccine product and dose has its own CPT code. Use these codes when requesting reimbursement from patients' private insurance or Medicare.

See the American Academy of Pediatrics’ COVID-19 Vaccine Administration: Getting Paid webpage for a list of all COVID-19 vaccine billing codes and more information.

HRSA COVID-19 stopped accepting claims

Due to the lack of supplemental funding from Congress, the Department of Health and Human Services’ Health Resources & Services Administration (HRSA) has stopped accepting claims for reimbursement of costs associated with administering COVID-19 vaccines to uninsured individuals as of 10:59 PM CST on April 5, 2022.

If you have any questions or want more information about the claims submission deadlines, refer to the webpages linked below, or contact the HRSA Provider Support Line at 1-833-967-0770; for TTY dial 1-888-970-2920. Hours of operation are 7 a.m. to 7 p.m. CT, Monday through Friday.

The Centers for Disease Control and Prevention (CDC) strongly encourages providers to stay in the CDC COVID-19 Vaccination Program. CDC expects participating providers will continue to administer these lifesaving vaccines at no cost to patients to ensure equitable access for all individuals.

 
Where CDC becomes aware of a provider engaging in any of the following, CDC will consider taking any and all appropriate measures, including the possibility of rescinding the CDC provider agreement:

  • Administering COVID-19 vaccine at any out-of-pocket cost to the recipient
  • Denying anyone vaccination, or differentially reducing appointment access, based on the vaccine recipient’s coverage status or network status
  • Charging an office visit or other fee if COVID-19 vaccination is the sole medical service provided
  • Requiring additional medical services to receive COVID-19 vaccination
  • Seeking any reimbursement, including through balance billing, from the vaccine recipient
Medicare COVID-19 vaccination for residents of small long-term care facilities

The Centers for Medicare & Medicaid Services (CMS) is expanding opportunities for people to receive COVID-19 vaccinations in their home. To ensure Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach can receive the vaccination, providers can now receive additional payments for administering vaccines to multiple residents in one home setting or communal setting of a home. Attached is the press release CMS sent out about this announcement on August 24, 2021.

CMS bolsters payments for at-home COVID-19 vaccinations for Medicare beneficiaries

On June 9, 2021, CMS announced an additional payment amount for administering in-home COVID-19 vaccinations to Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach. There are approximately 1.6 million adults age 65 years or older who may have trouble accessing COVID-19 vaccinations because they have difficulty leaving home. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. For a two-dose vaccine, this results in a total payment of approximately $150 for the administration of the full series or approximately $70 more than the current rate.

See more information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates.

Report inappropriate billing practices and denied access to COVID-19 vaccine

Individuals aware of any potential violations of these requirements are encouraged to report them to DHS.

Additional vaccinator and stakeholder resources

Vaccine administration site and needle length

All COVID-19 vaccines get administered through intramuscular (IM) needle insertion.

Whether the vaccine is administered in the deltoid muscle or the anterolateral thigh depends on the patient's age.

Use the correct needle length for the patient's age, weight, and administration site to ensure proper IM administration. However, it is critical for all IM injections that the needle be long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue. The most common technique when administering an IM injection is grabbing the muscle and bunching subcutaneous and muscle tissue to minimize the chance of striking bone. Studies have shown that use of longer needles is associated with less redness or swelling than occurs with shorter needles because of injection into deeper muscle mass.

See our Vaccine Administration, P-03253 needle gauge and length chart and IM injection guidance.

Further vaccine administration guidelines are outlined in the ACIP Vaccine Administration Guidelines for Immunization webpage. CDC also has a video overview of IM injections to assist providers.

Tips for vaccinating children

Do you need trainings and resources on creating a youth- and adolescent-friendly environment at your clinic? Check out University of Michigan’s Adolescent Health Initiative 15-minute, ready-to-use trainings that can be delivered to your entire health center or organization.

 

Nurses with experience vaccinating children shared the following tips to help create a more pleasant childhood vaccination experience. For more details you can listen to the DHS panel discussion on COVID-19 Vaccination in Children 5-11 Years Old.

  1. Make sure your clinic space is set up with children in mind.
    1. You may need more chairs so care takers and their children can sit together.
    2. If working in a large open space such as a school gym, putting up screened areas in a large open space can give children more privacy. Young children need more privacy because they may start crying if they see another child crying.
  2. Stay calm.
    1. Help the child’s caregiver to remain calm as well by talking them through the process.
    2. A calm, friendly voice helps the child feel more at ease.
    3. Use positive words when talking about vaccines, such as saying pinch or poke instead of shot or pain.
    4. Don’t apologize for giving them a vaccine. You are giving them the gift of protection.
  3. Have all of your supplies handy.
    1. Make sure you have your emergency use authorization fact sheets, needles, Band-Aid, and other tools necessary to administer the vaccine. Review other vaccine administration best practices on this page.
    2. Have other useful tools like stickers, distraction toys, or sweets to help children feel comfortable during and after getting their vaccine.
  4. Use techniques to minimize the child’s perception of pain.
    1. Rub the area where you will administer the vaccine.
    2. Encourage the child’s parent or caretaker to hold and stabilize the child using comforting positions. Learn more about Comforting Children During Vaccination, P-03252.
    3. Distract the child or ask the child’s caregiver to help with distraction. For example, have them sing a song, blow on a pin wheel, breathe using the 4-7-8 technique, or watch a YouTube video.
  5. Congratulate the child for getting the vaccine and remind the caregiver to schedule their second COVID-19 dose.

Tips on how to be there for your child during vaccinations, P-03126You can give parents and caregivers the DHS resource How to Be There For Your Child to help them before, during, and after vaccination. This resource is available in several languages.

Guidance for community-based and at-home vaccination

An important method to help people to get vaccinated, is to bring the vaccine to them with more targeted and flexible community-based vaccination strategies, like pop-up clinics at schools and other trusted spaces.

Fill out this survey if you want to be listed as a vaccinator that employers and community-based organizations can contact to hold an on-site clinic. Vaccinators should also consider connecting with their local and tribal health department about how to reach key community-based organizations in your area or reach out directly to organizations.

Planning vaccine clinics for children
DHS guidance for community vaccination

DHS published the following documents to guide local and tribal health departments, vaccinators, and other stakeholders in bringing vaccine to individuals in new spaces, in an equitable way.

  • Community Walk-In Vaccination Clinic Guidance for Providers
    Community walk-in clinics can help advance equity among communities and populations who face significant barriers to accessing vaccination. A walk-in vaccination clinic does not require appointments or pre-registration, but rather allows individuals to walk-in at any time during the clinic hours. DHS encourages vaccinators to leverage this tactic when planning or operating a vaccination clinic.
  • Community-Based Vaccination Clinic Checklist and Equity Considerations
    This checklist will help inform partners who are planning to set up, support, or partner on community-based vaccination clinics. The checklist covers both operational and logistical considerations, as well as equity considerations that will help to make the site accessible and welcoming.
  • Guidance for Reaching Individuals Who are Homebound or Have Mobility Concerns
    DHS recognizes that access to COVID-19 vaccinations may be a challenge to some people, especially for those who are homebound. This document provides resources to aid vaccinators in partnering with local and state organizations to identify and vaccinate individuals who are homebound. Transportation resources are also listed for individuals who can travel but require additional assistance. While every community is different, these resources offer information each community can adapt to their specific needs.

    AMI Expeditionary Healthcare (AMI) conducts COVID-19 vaccination visits for people who are homebound. If you or a partner have identified someone who needs help accessing COVID-19 vaccines at home, reach out to your local or tribal health department or refer to this list of groups providing at home vaccination developed by 211 Wisconsin. Local and tribal health departments can email DHSCovidVaccinePublic@wi.gov to be connected with AMI to schedule homebound vaccination appointments.

  • Guidance for Community and Faith-Based Organizations
    As trusted community leaders, community and faith-based organizations play an important role in protecting their members and communities. Recognizing these organizations as valuable partners in our efforts to advance vaccine equity, this guide helps organizations by providing resources to promote vaccine confidence and education, identifying the various ways to connect individuals to vaccination options, and how to approach partnerships to support community-based vaccination efforts.
  • Guidance for Wisconsin Employers
    This document has been developed to provide guidance for employers to prepare for vaccination either through community efforts or at the workplace. Workplace vaccination is a critical strategy in reaching individuals who might otherwise be hard to reach. DHS encourages all vaccinators to support employers who wish to provide vaccination for their employees. Consider connecting with your LTHD about how to reach employers in your area or reach out directly to businesses.

Vial adaptors or spikes not recommended

Due to the risk of contamination, use of vial adaptors or spikes are not recommended by either the CDC or U.S. Pharmacopeia as a means of extracting doses from a vial of COVID-19 vaccine. Unlike many vaccines, COVID-19 vaccines do not contain a preservative, which increases the risk for potential contamination. Additional information can be found on page four of the USP COVID-19 Vaccine Toolkit and on the CDC Injection Safety Medication Preparation page.

Doses per vial and interval between doses

Doses per vial
Vaccine Age of recipient Dilution needed Dose Injection volume Doses per vial
Pfizer (maroon cap) 6 months – 4 years Dilute each vial with 2.2 mL of diluent 3 µg 0.2 mL 10
Pfizer (orange cap) 5–11 years Dilute each vial 1.3 mL of diluent 10 µg 0.2 mL 10
Pfizer (gray cap) 12 and older years No dilution 30 µg 0.3 mL 6
Moderna (blue cap, magenta label border) 6 months – 5 years No dilution 25 µg 0.25 mL 10
Moderna (blue cap, purple or teal label border) 6 years – 11 years No dilution 50 µg 0.5 mL 5
Moderna (red cap, light blue border) 12 years and older No dilution 100 µg 0.5 mL* (0.25 mL booster) 10-20*
Johnson & Johnson 18 years and older No dilution 5×1010 viral particles 0.5 mL 5
Novavax 18 years and older No dilution 5 µg rS and
50 µg of Matrix-M™ adjuvant
0.5 mL 10

 

*Because people 18 years and older can get a Moderna (red cap) booster dose with a volume of 0.25 mL (half the dose provided in the primary series), each Moderna (red cap) vial will contain either the maximum number of full doses (10 doses), 20 half (booster) doses, or a combination of full and half doses. See the Moderna product-specific page for more information.

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.

Interval between doses

Below is the CDC's COVID-19 vaccination schedule for most people (who are not moderately or severely immunocompromised). The number of doses and the interval between doses differ for people who are moderately or severely immunocompromised and for people who received a vaccine not authorized in the U.S.

COVID-19 vaccination schedule for most people

Note: People ages 12 through 64 years who are not moderately or severely immunocompromised—especially males ages 12 through 39 years—may benefit from getting their second mRNA COVID-19 vaccine dose 8 weeks after the first dose.

A shorter interval (3 weeks for Pfizer-BioNTech and Novavax; 4 weeks for Moderna) between the first and second doses remains the recommended interval for:

  • People who are moderately to severely immunocompromised
  • Adults ages 65 years and older
  • Others who need rapid protection due to increased concern about High COVID-19 Community Levels or risk of severe disease.

 

The second dose of Pfizer, Moderna, and Novavax vaccines should be administered as close to the recommended interval as possible, but not earlier than recommended. For example, three weeks for Pfizer and Novavax, or four weeks for Moderna.

However, second doses administered within a grace period of four days earlier than the recommended date for the second dose are still considered valid. If a dose is administered prior to the 4-day grace period and is a:

  • Primary series dose: it should be repeated. The repeat dose should be spaced from the date of the dose given in error by the recommended minimum interval.
  • Booster dose administered prior to the minimum interval:
    • Repeat dose if this is the first booster dose. Space repeat dose after the dose given in error by at least the minimum interval (2 months after Johnson & Johnson vaccine primary series and at least 3 months after mRNA vaccine primary series).
    • Do not repeat dose if this is the second booster dose.

Doses administered at any time after the recommended interval are valid.

 Vaccination clinical guidance

Useful tools and resources:

EpiPens for COVID-19 vaccination of children

Please note that epinephrine auto-injectors or epinephrine will not be provided to vaccination sites for COVID-19 vaccines for children.

Vaccinators need to ensure that emergency equipment is available when vaccinating children, regardless of the vaccine being administered. This includes epinephrine auto-injectors or epinephrine. If an ampule of epinephrine and needle/syringe is to be used, it is important that the provider be proficient in drawing up and administering the proper dosage.

ACIP General Best Practice Guidelines read, “Epinephrine and equipment for managing an airway should be available for immediate use.”

Ancillary supplies provided with COVID-19 vaccination program for children do not include epinephrine auto-injectors or epinephrine.

COVID-19 vaccine providers are expected to supply epinephrine auto-injectors or epinephrine and assure this emergency equipment is available during administration of vaccine to children and adults.

If your primary adverse reaction plan involves calling 911 as your primary support, reach out to your local Emergency Medical Services (EMS) agency or local and tribal health department (LTHD) to discuss their capacity, training and readiness, and ability to respond an event in a timely fashion. It is also critical that you regularly communicate with EMS and your LTHD regarding planned clinic days and times so they are properly staffed and prepared if an adverse event occurs.

The Immunization Action Coalition (IAC) provides the following handouts for management of vaccine reactions:

Parental consent for vaccination of individuals under the age of 18

According to the CDC, state laws establish vaccination requirements for school-aged children. In Wisconsin, the age of majority is 18 years of age, unless emancipated. Therefore, all unemancipated individuals under 18 years of age require parent or guardian consent to receive the COVID-19 vaccine.

In Wisconsin, vaccinators are able to accept written or verbal (such as via telephone) consent to administer the COVID-19 vaccine from the minor’s legal parent or guardian who cannot be present at the time of vaccination. Vaccinators are not required to accept written or verbal consent but are permitted to accept these forms of consent should they choose to do so. DHS does not have a sample written consent form for vaccinators to use. Vaccinators are encouraged to work with their own legal counsel regarding methods of consent for vaccinating minors in their clinic.

Booster dose

While booster doses are an important step in increasing access to enhanced protection for people across Wisconsin, there remains large populations of people who are unvaccinated and who are at risk of serious illness and death. We need a strong continued focus on increasing primary series vaccination among these individuals. You can find several resources to support these conversations on the DHS COVID-19 Vaccine Partner and Vaccinator Resources webpage.

First booster doses

Most* people 5 years and older should receive a booster dose for the best protection against COVID-19. Children 6 months - 4 years old are not yet eligible to receive booster doses.

People who are not immunocompromised should get one booster dose:

  • At least five months after the second dose of a Pfizer-BioNTech vaccine if they are 5 years and older.
  • At least five months after the second dose of a Moderna vaccine if they are 18 years and older.
  • At least two months after a single Johnson & Johnson vaccine if they are 18 years and older.

*The guidance for booster dose schedules is different for people who are moderately or severely immunocompromised, and for people who received a vaccine not authorized in the U.S.

Eligible individuals ages 18 years and older may choose which vaccine they receive as a booster dose, regardless of which vaccine they received in their primary series. For booster vaccination, Moderna and Pfizer-BioNTech are recommended and must be used for the second booster dose. Janssen COVID-19 Vaccine should only be used in limited situations due to the risk of TTS following receipt of Johnson & Johnson COVID-19 vaccine, whenever possible or appropriate. However, offering Johnson & Johnson COVID-19 vaccine is preferable to not providing any COVID-19 vaccine.

At this time, the Pfizer vaccine is the only vaccine authorized as a booster dose for people ages 5-17 years old. The Pfizer-BioNTech COVID-19 vaccine supplied in a vial with an orange cap is authorized for use only in children ages 5-11 years. It is not interchangeable with Pfizer-BioNTech COVID-19 vaccine for people ages 12 years and older (supplied in vials with a purple cap or a gray cap).

Second booster doses

The following people should get a second mRNA booster dose four months after their first booster dose:

  • People ages 12 years and older who are moderately or severely immunocompromised who received Pfizer
  • People ages 18 years and older who are moderately or severely immunocompromised who received Moderna or Johnson & Johnson
  • People ages 50 years and older who received Pfizer, Moderna, or Johnson & Johnson

People who are 18 years or older and received both a first dose and booster dose of Johnson & Johnson may choose to receive a second booster dose of Pfizer or Moderna four months after their first Johnson & Johnson booster.

For protection purposes, a person is considered “boosted” and up to date with COVID-19 vaccines immediately following receipt of all COVID-19 primary series and booster doses recommended for them. There is not a 2-week period to develop immunity since the immune system is already primed.

For information on the timing of administration of the first and second booster doses after SARS-CoV-2 infection, see CDC's guidance on COVID-19 vaccination and SARS-CoV-2 infection.

Observation period for boosters

Individuals receiving COVID-19 booster shots need to be monitored for allergic reactions for 15-30 minutes after vaccination. Non-reactions to previous vaccinations are not a guarantee that a reaction will not occur with the booster shot. When administering booster doses, please make sure people wait before they leave your site.

This is also a good time to encourage individuals to sign up for v-safe. For people who have already enrolled, v-safe is not automatically notified when a person receives another dose of vaccine. Please let individuals know that they must enter the additional dose in their account before the system will send health check-ins.

Vaccine cards not required to get a COVID-19 vaccine booster

DHS urges vaccinators to administer a COVID-19 vaccine booster even if a patient does not have a COVID-19 vaccine card with them. DHS encourages vaccinators to look up the patient vaccination records in the WIR and reissue a new card with the booster information and the information found in WIR from the primary series.

If vaccinators do not have WIR access, please administer the vaccine, provide the individual with a record of the administered vaccine on a new card, and then inform the patient to call the provider or organization where they were originally vaccinated to potentially obtain a card with the prior doses. Vaccinators can also encourage the patient to visit WIR themselves for their vaccination information.

DHS cannot issue COVID-19 vaccination cards.

Syringe extraction guidance

The Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC) do not yet have any official guidance regarding use of syringes with 0.2 mL tick marks to draw up doses of Moderna booster vaccine (0.25 mL).

Vaccinators using syringes that have tick marks at 0.2 mL intervals should use their best judgment to draw up halfway between the tick marks to extract the proper volume. For example, Moderna booster vaccine should be drawn between 0.24 mL and 0.26 mL.

Alternately, if vaccinators have syringes in their private inventory that they are more comfortable using, they may use this syringe to administer the vaccine and replace syringes from their private supply with those from the ancillary supplies kit.

Additional resources

Vaccinating people who are moderately to severely immunocompromised

People who are immunocompromised are especially vulnerable to COVID-19 infection and may have a lower immune response to the original vaccine series compared to people who are not immunocompromised.

Because of this differing immune response following COVID-19 vaccination, people who are moderately or severely immunocompromised are recommended to an additional mRNA dose and two booster doses, when eligible. Recipients can be guided to DHS's COVID-19: Vaccine Guidance for People Who Are Moderately or Severely Immunocompromised webpage for more information.

Vaccinators should review CDC’s Interim Clinical Considerations prior to administering additional doses.

COVID-19 vaccination schedule for people who are moderately to severely immunocompromised

For more information see CDC’s COVID-19 vaccination guidance for people who are moderately or severely immunocompromised.

Who is considered moderately to severely immunocompromised?

At this time, only individuals with specific medical conditions or receiving medical treatments that cause them to be moderately to severely immunocompromised are recommended to get an additional dose of Pfizer or Moderna COVID-19 vaccine. This includes but is not limited to people with the following conditions and treatments:

  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
  • Moderate or severe primary immunodeficiency (such as, DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids (such as, doses greater than or equal to 20mg of prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
Further protection

Although, administration of a third COVID-19 mRNA vaccine dose as part of a primary series among immunocompromised adults has been shown to improve protection against COVID-19–associated hospitalization, another study shows waning 3-dose effectiveness among adults during periods of delta and omicron variant predominance.

Vaccinated people who are immunocompromised should be counseled about the potential for a reduced immune response even after their additional mRNA COVID-19 vaccine dose. Please reinforce the need for immunocompromised people and their close contacts to continue to follow current prevention measures (including wearing a mask and physical distancing).

Close contacts of immunocompromised people who are not yet up to date on their vaccines should also be strongly encouraged to be vaccinated against COVID-19.

WIR considerations

If a client received two doses of a primary mRNA COVID-19 vaccine series, the schedule will be noted as complete in WIR. The first and second doses of a primary will show as “1 of 2” and “2 of 2” vaccines in the series, respectively.

The additional dose will not be forecasted by the WIR but will be recorded in the individual's immunization record once administered. However, the "Series" column will be blank for that dose as it is not considered part of the primary series.

Off-label use of COVID-19 vaccines

Vaccine providers are responsible for adhering to all requirements outlined in the CDC COVID-19 Vaccination Program Provider Agreement. This applies to COVID-19 vaccines either authorized or approved by the FDA. Accordingly, use of these products outside of those that have been approved and authorized by FDA (off-label use) is not recommended. It would violate the provider agreement and could expose providers to the following risks:

  • Administration of the product off-label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims.
  • Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
  • CDC has defined the scope of the CDC COVID-19 Vaccination Program in terms of how the U.S. government-provided vaccines may be used in the program. Providers giving off-label doses would be in violation of the CDC Program provider agreement, potentially impacting their ability to remain a provider in the CDC program.
  • Administration fees may not be reimbursable by payers.

Recommendations for COVID-19 vaccination during pregnancy

CDC and DHS recommend urgent action to increase COVID-19 vaccination among people who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future. For more information, view CDC's Health Advisory (HAN-00453).

Low vaccine uptake among pregnant people and the increased risk of severe illness and pregnancy complications related to COVID-19 infection among pregnant people make vaccination for this population more urgent than ever.

An analysis of current data from the v-safe COVID-19 Vaccine Pregnancy Registry assessed vaccination early in pregnancy and did not find an increased risk for miscarriage among people who received an mRNA COVID-19 vaccine before 20 weeks of pregnancy. Miscarriage rates after receiving a COVID-19 vaccine were similar to the expected rate of miscarriage. Additionally, previous findings from three safety monitoring systems did not find any safety concerns for pregnant people who were vaccinated late in pregnancy or for their babies.

Note that Johnson & Johnson (Janssen) was not analyzed in this study due to the small sample size (n=272). This is because Johnson & Johnson vaccine received its EUA authorization more recently compared to the mRNA vaccines. Therefore, the majority of pregnant people who may have received Johnson & Johnson vaccine are still pregnant. CDC continues to monitor and evaluate COVID-19 vaccines.

Key Messages

  • In an analysis of current data from the v-safe COVID-19 Vaccine Pregnancy Registry, scientists did not find an increased risk for miscarriage among people who received an mRNA COVID-19 vaccine before 20 weeks of pregnancy. This adds to the growing evidence of the safety of these vaccines.
  • Pregnancy increases the risk for severe illness from COVID-19. Pregnant people are more likely to be hospitalized, require critical care including ventilation, and admission to the intensive care unit. In addition, COVID-19 during pregnancy increases the risk for preterm birth of the infants.
  • CDC recommends that pregnant people should be vaccinated against COVID-19 if not already vaccinated, based on new evidence about the safety and effectiveness of the COVID-19 vaccines. COVID-19 vaccination is recommended for all people 6 months and older, including people who are pregnant, breastfeeding, or trying to get pregnant now or might become pregnant in the future.
  • Data from Vaccine Safety Datalink show that only 23% of pregnant people received at least one dose of COVID-19 vaccine during pregnancy, as of July 31, 2021.
  • The American College of Obstetricians and Gynecologists and 21 of the leading organizations representing experts in maternal care and public health professionals also issued a statement strongly urging pregnant individuals to be vaccinated against COVID-19.
  • Summary from v-safe analysis:
    • This report included 2,456 pregnant people enrolled in the v-safe COVID-19 Vaccine Pregnancy Registry who received at least one dose of an mRNA COVID-19 vaccine just before pregnancy or prior to 20 weeks of pregnancy (as of July 19, 2021).
    • Miscarriage, or loss of a pregnancy before 20 weeks, is common, occurring in about 11-16% of pregnancies. In this study, the cumulative risk of miscarriage after receiving an mRNA COVID-19 vaccine was similar (13%) to previously published baseline estimates of miscarriage (11-16%).
    • These data have limitations. There is no direct comparison group of pregnant people who are not vaccinated so rates are compared to published data. The participants are of similar race/ethnicity (mostly non-Hispanic white) and job categories (mostly healthcare professionals). A high percentage are older than 35 years of age, which is a known risk factor for miscarriage. All data were self-reported. These and other characteristics may limit how generalizable the findings are and may over- or under-estimate the proportion who reported miscarriage after vaccination.
    • Scientists continue to monitor pregnancies in the v-safe COVID-19 Vaccine Pregnancy Registry and other safety monitoring systems and several clinical trials of COVID-19 vaccines are underway in pregnant people.

Potential questions and answers

American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) strengthened their recommendations for pregnant people a couple weeks ago. What took CDC so long? Why now?

  • Clinicians caring for pregnant people have seen an increase in the number of pregnant people with COVID-19 in the past several weeks. The increased circulation of the highly contagious Delta variant, the low vaccine uptake among pregnant people, and the increased risk of severe illness and pregnancy complications related to COVID-19 among pregnant people make vaccination for this population more urgent than ever. A strong recommendation by CDC and DHS, that aligns with strengthened recommendations recently released from several clinical organizations (ACOG and others), will ensure that there is consistent messaging to healthcare providers and pregnant people about the lifesaving benefits of vaccination.
  • Previously, preliminary safety data on vaccinations late in pregnancy were reassuring, but data from people vaccinated during early pregnancy were lacking. These new findings—no increased risk for miscarriage after receiving an mRNA vaccine before 20 weeks of pregnancy—helped to fill that gap in knowledge. The growing evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy suggests that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks and vaccination is essential to protect pregnant people.

The risk of miscarriage was 13% in women vaccinated prior to 20 weeks’ gestation—is that higher than you would expect?

  • No, miscarriage rates after receiving an mRNA COVID-19 vaccine are not higher than we would expect. In fact, they are within what we expect to see based on previous studies of miscarriage rates in the general population (11-16%). These data do not suggest an increased risk for miscarriage after receiving an mRNA COVID-19 vaccine just before or within the first 20 weeks of pregnancy. CDC is committed to continuing to learn about COVID-19 vaccination during pregnancy and will update healthcare providers and the public as more data become available.

We ask you to share our strengthened recommendation widely with your patients, partners, and networks and on your organization’s social media pages.

Myocarditis and pericarditis after COVID-19 vaccination

Increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination, particularly in adolescents and young adults. There has not been a similar reporting pattern observed after receipt of the Johnson & Johnson (Janssen) COVID-19 vaccine.

CDC continues to recommend COVID-19 vaccination for everyone 6 months and older, given the risk of COVID-19 illness and related, possibly severe complications, such as long-term health problems, hospitalization, and even death. The known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis. Also, most patients with myocarditis and pericarditis who received care responded well to medicine and rest and quickly felt better.

Reported cases have occurred predominantly in male adolescents and young adults ages 16 years and older. Onset was typically within several days after mRNA COVID-19 vaccination, and cases have occurred more often after the second dose than the first dose. CDC and its partners are investigating these reports of myocarditis and pericarditis following mRNA COVID-19 vaccination.

No cases of myocarditis were reported among the 3,082 participants aged 5–11 years in Pfizer-BioNTech’s vaccine trial, although the study was not powered to assess the risk for myocarditis. There were also no cases of myocarditis in the vaccine trials for children 6 months – 4 years (Pfizer) or children 6 months – 5 years (Moderna). Based on epidemiology of myocarditis and safety monitoring in children ages 5-11, myocarditis after mRNA COVID vaccination in young children is anticipated to be rare (Evidence to Recommendations Framework, Dr. Sara Oliver, slide 62).

Vaccination is important because the risk of myocarditis or pericarditis associated with SARS-CoV-2 infection is greater than the risk of myocarditis or pericarditis occurring after receipt of an mRNA COVID-19 vaccine in adolescents and adults. However, people who develop myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine generally should not receive a subsequent dose of any COVID-19 vaccine. For more information see the CDC clinical considerations on contraindications and precautions.

 

In safety monitoring of COVID-19 vaccine booster doses among people aged 12–17 years myocarditis was less frequently reported after a booster dose than a second primary dose.

Health care providers should consider myocarditis in an evaluation of chest pain after vaccination and report all cases to the Vaccine Adverse Event Reporting System (VAERS) in a timely manner.

View the following resources for additional information:

Co-administering COVID-19 vaccines with other vaccines

COVID-19, influenza, and other vaccines may be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccines and other vaccines on the same day, as well as co-administration within 14 days.

Giving all vaccines for which an individual is eligible at the same visit is considered a best practice as it increases the probability that individual will be up to date on recommended vaccines. It also is an important part of immunization practice, especially if a health care provider is uncertain that a patient will return for additional doses of vaccine.

 

There may be compelling logistical advantages to offering patients COVID-19 and other vaccines on the same day, and you may encourage patients to receive these on the same day.

When deciding whether to co-administer other vaccine(s) with COVID-19 vaccines, consider:

  • Whether the patient is behind or at risk of becoming behind on recommended vaccines.
  • The patient’s risk of vaccine-preventable disease, such as through occupational exposures or during an outbreak.
  • The reactogenicity profile of the vaccines.
    • It is unknown whether reactogenicity (the degree to which the vaccine can cause side effects) of COVID-19 vaccine is increased with co-administration, including with other vaccines known to be more reactogenic, such as adjuvanted vaccines or live vaccines.
  • The likelihood of avoiding a missed opportunity to vaccinate.
    • This is an important update for preteens, teens, and adults who need to catch up on routinely recommended vaccinations. According to the CDC, vaccination rates dropped substantially during the pandemic, particularly among adolescents.
Best practices for multiple injections include:
  • Label each syringe with the name and the dosage (amount) of the vaccine, lot number, the initials of the preparer, and the exact beyond-use time, if applicable.
  • Administer each injection in a different injection site. For adolescents and adults, the deltoid muscle can be used for more than one intramuscular injection.
  • Separate injection sites by one inch or more, if possible.
  • Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction (such as, tetanus toxoid containing and adjuvanted vaccines) in different limbs, if possible.

Please reference CDC's clinical considerations for more details. CDC's short recorded webinar on Administering More Than One Vaccine on the Same Day reviews the clinical considerations, best practices and clinical resources for simultaneous administration.

Preventing accidental influenza and COVID-19 vaccine mix-ups

Since the start of 2021-22 influenza vaccination, the Institute for Safe Medication Practices (ISMP) has received several cases of accidental influenza and COVID-19 vaccine mix-ups. Most of the mix-ups occurred in patients who consented to a flu vaccine but received one of the COVID-19 vaccines instead.

The following prevention measures are recommended to prevent administration of the wrong vaccines:

  • Schedule flu and/or COVID-19 vaccines during dedicated blocks of time each day and ensure adequate staffing is available.
  • Explore the use of qualified and trained volunteers to assist in the vaccination process to alleviate some stress caused by professional staffing shortages.
  • Provide a separate area for vaccine administration, away from distractions and interruptions.
  • During the production and/or verification phase of the dispensing process, scan the vaccine barcode to verify the correct product has been retrieved. Ideally, prior to administration, barcode scanning should again confirm the correct vaccine.
  • Clearly label all individual syringes containing vaccines. To facilitate proper labeling, provide vaccine preparers with any necessary labels to affix to the syringes.
  • Only bring the intended and labeled vaccine syringe(s) for one patient into the vaccination area.
  • Immediately before vaccination, ask the patient to provide at least two patient identifiers, such as full name and date of birth, and verify the patient’s vaccine(s) with the patient’s signed consent form(s).
  • Prior to vaccine administration, ask the patient/parent to read the syringe label (and vial if present) and expiration date aloud to confirm the correct vaccine.
  • Document the vaccine lot number and expiration date before vaccine administration. Document the vaccine administration afterward in the patient’s profile, on vaccination records, and via state or other immunization registries.
  • If a vaccine mix-up occurs, apologize to the patient, and provide the intended vaccine either before the patient leaves or ask the patient to return to the vaccination site.
  • Report all vaccine errors internally as well as to the US Food and Drug Administration (FDA) Vaccine Adverse Event Reporting System (VAERS), which is mandatory for COVID-19 vaccine errors under an Emergency Use Authorization (EUA). ISMP also asks providers to report vaccine errors to the ISMP National Vaccine Errors Reporting Program (ISMP VERP).

The full ISMP report shares more information about the possible contributing factors for the vaccine mix-ups.

Improving series completion rates

There are several reminder strategies to bolster the likelihood of patients returning for second visits, such as:

  • Filling out and giving patients the CDC vaccination card. This card tells patients what COVID-19 vaccine they received, the date they received it, and where they received it. They are instructed to keep it as a reminder for their second appointment and for their records.
  • Using the reminder/recall report in WIR.
  • Encouraging patients to sign up for v-safe as it reminds people to get their second COVID-19 dose along with easy reporting of side effects. Adults can enroll multiple children in v-safe and complete health check-ins on their behalf after they have been vaccinated for COVID-19.

Vaccine safety system and reporting adverse events

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

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

V-safe is a 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 event 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.

 

Health care personnel or health departments in the U.S. 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 U.S. not readily addressed by CDC guidance.

Request a consultation from CISA by:

 Calling 800-CDC-INFO (800-232-4636)

 Submitting a request via a web form

 

For more information about vaccine safety, review What Every Clinician Should Know about COVID-19 Vaccine Safety. You can also read more about current data on adverse events, local and system reactions to Moderna and Pfizer COVID-19 vaccines.

Email us if you have more questions about vaccine safety or reporting adverse events.

 Product-specific resources and guidance

Pfizer-BioNTech     Moderna     Novavax     Johnson & Johnson

 

 Vaccine ordering process

Useful tools and resources:

Ordering process steps

Vaccinators are responsible for ordering second doses. Second doses will not be sent automatically.

Please continue to use the Pfizer Purple Cap formulation before ordering the Pfizer Gray Cap formulation, when possible. Remember to keep your inventory of Purple and Gray Caps separate to avoid confusion with diluent, as the Purple Cap formulation uses diluent while the Gray Cap formulation does not.

Step 1: Check the Wisconsin COVID-19 Vaccine Exchange to see if another provider has COVID-19 vaccine to redistribute to you.
  1. Please check and use this tool prior to ordering COVID-19 vaccine through WIR.
    • All providers are encouraged to offer and accept redistributed doses, regardless of the probability of wastage.
    • Requesting vaccine through the Wisconsin COVID-19 Vaccine Exchange is the only way you can order doses in smaller increments than those provided by hubs or manufacturers.
    • The recorded webinar from June 8, 2021 includes an overview and background information about the Wisconsin COVID-19 Vaccine Exchange, starting at minute 16:00.
  2. Using the Request Vaccine form on the bottom right of the Vaccine Exchange page, identify the row ID of the offering vaccinator you would like to match with.
  3. Once a match is made, both vaccinators will receive an email with contact information to take next steps.
    • Vaccinators are responsible for working together to redistribute the COVID-19 vaccine. This includes ensuring both entities have approved Redistribution Forms, arranging the transportation according to storage and handling guidelines, and completing the transfer in WIR.
    • If you need to remove your listing, please request the vaccine using the Request Vaccine Form, fill out the appropriate fields, enter in your row ID, and ask for zero doses. Click submit, then refresh the page. This will remove your listing.
Step 2: For additional vaccine, order COVID-19 vaccine through the COVID-19 Vaccine Ordering Survey.

Note for VFC and VFA providers: this process is different than ordering vaccine for those two programs.

 

  1. Log into WIR and navigate to the announcements section.
  2. Click on the link to the COVID-19 Vaccine Ordering Survey in the announcement. You may also bookmark the direct link as it will not change.
  3. Order a three-to-four-week supply of COVID-19 vaccine.
  4. After completion and submission of a request through the COVID-19 Vaccine Ordering Survey, a “Download” button message will appear near the bottom of the screen. DHS is encouraging vaccinators to click on the “Download” button to save a PDF of the submission for their records.
  5. Vaccine orders will be viewable in WIR by the next evening to track any related updates to the order. If you have questions, issues, or the need to change or cancel an order, email DHSCovidVaccinator@wi.gov. The request to change or cancel a direct ship order must be received no later than 12 p.m. (noon) on Tuesdays. Changes cannot be made after this time. A reminder that direct ship orders submitted after 12 p.m. (noon) on Tuesdays will be held and processed the following week.

Vaccine ordering amounts

DHS will be limiting direct ship vaccine orders going forward. DHS is making this change due to an increase in excess vaccine reported in the state. The change is designed to decrease excess supply, vaccine wastage, and inaccurate reporting in WIR. To support correcting Wisconsin’s vaccine inventory data, all orders submitted through the survey will be reviewed by staff to verify accurate inventory.

Vaccine ordering amounts and increments

Reminder: As vaccine demand changes and the CDC offers new configurations, the COVID-19 vaccines available for ordering in WIR and minimum ordering amounts will continue to change.

Please order a three-to-four-week supply of vaccine.

Vaccine Type Ordering Amounts and Delivery
Pfizer 6mo-4Y (maroon cap)

Hub-delivery:

  • Minimum of 30 doses.
  • Increments of 10 doses (1 vial).
  • Maximum 90 doses.

Direct ship:

  • Minimum of 100 doses.
  • Increments of 100 doses.
Pfizer 5Y-11Y (orange cap)

Hub-delivery:

  • Minimum of 30 doses.
  • Increments of 10 doses (1 vial).
  • Maximum 90 doses.

Direct ship:

  • Minimum of 100 doses.
  • Increments of 100 doses.
Pfizer 12Y+ (gray cap)

Hub-delivery:

  • Minimum of 30 doses.
  • Increments of 6 doses (1 vial).
  • Maximum 270 doses.

Direct ship:

  • Minimum of 300 doses.
  • Increments of 300 doses.
Moderna 6mo-5Y (dark blue cap, magenta label border)

Hub-delivery:

  • Minimum of 30 doses.
  • Increments of 10 doses (1 vial).
  • Maximum 90 doses.

Direct ship:

  • Minimum of 100 doses.
  • Increments of 100 doses.
Moderna 6Y-11Y (dark blue cap, purple label border)

Hub-delivery:

  • Minimum of 30 doses.
  • Increments of 5 doses (1 vial).
  • Maximum 90 doses.

Direct ship:

  • Minimum of 100 doses.
  • Increments of 100 doses.
Moderna 12Y+ (red cap)

Hub-delivery:

  • Minimum of 30 doses.
  • Increments of 10 doses.
  • Maximum 90 doses.

Direct ship only:

  • Minimum of 100 doses.
  • Increments of 100 doses.
Novavax (royal blue cap)

Hub-delivery:

  • Minimum of 30 doses.
  • Increments of 10 doses.
  • Maximum 90 doses.

Direct ship only:

  • Minimum of 100 doses.
  • Increments of 100 doses.
Johnson & Johnson 18Y+ (blue cap)

Only available through the Wisconsin COVID-19 Vaccine Exchange.

 

Note: The only way to get vaccine in smaller increments than those noted above, is to request vaccine through the Wisconsin COVID-19 Vaccine Exchange.

Defining terms
  • Direct ship: The manufacturers ship the vaccine directly to the provider. Providers will receive an automated confirmation email from the shipper confirming delivery.
  • Hub delivery: Regional managers organize the delivery of the vaccine from the hub to the provider. Providers will be contacted by their regional manager to confirm delivery.

Whether a vaccine order gets shipped via hub delivery or direct ship depends on the vaccine type and the quantity ordered.

  • Pfizer orders of full trays (increments of 300 doses of gray cap vaccine) for people 12 years and older will be direct shipped at ultra-low temperatures. All other size Pfizer Tris 12+ orders will be delivered from hubs at refrigerated temperatures.
  • Moderna, Novavax, and other Pfizer vaccines will be direct shipped if ordered in quantities of 100 doses. Orders of 30 to 90 doses will be fulfilled through hub delivery.

See the following section for the difference between hub delivery and direct shipment order delivery timelines.

Order delivery and pick-up timelines

Order delivery timelines

Hub orders are shipped daily. Regional managers will contact providers to schedule the delivery of vaccine.

Direct ship orders are processed weekly on Tuesdays. Vaccine orders submitted after 12:00 p.m. on Tuesdays will be held and processed the following Tuesday. Direct ship orders submitted by noon on Tuesday, order will be processed on Wednesday and Thursday and will be delivered within the next one and three business days.

See the previous section (Vaccine ordering amounts) for the definitions and descriptions of hub deliveries and direct shipments.

 

The table below shows the earliest expected delivery day for when the vaccine order was submitted.
Order Submitted by Noon on: Earliest Expected Delivery Day
  Direct Ship Vaccine Hub Delivery Vaccine
Monday Following week's Monday/Tuesday Delivery times vary by region. Regional managers will call to schedule delivery.
Tuesday Following week's Monday/Tuesday
Wednesday Monday/Tuesday in two weeks
Thursday Monday/Tuesday in two weeks
Friday Monday/Tuesday in two weeks
Order pick-up timelines

Vaccinators also have the option of picking up their orders at the hub. Order pick-up is available Monday through Friday between 11 a.m. and 2 p.m. Vaccinators can schedule pick-up by contacting their regional manager. Vaccinators are responsible for following all storage and handling guidelines as well as having the appropriate transport equipment to ensure the proper temperature control for the vaccine.

 Storage and handling guidance

Useful tools and resources:

General storage and handling best practices

Please remember to:

  • Promptly add administered doses to WIR.
  • Update inventory daily in WIR.
  • Check inventory for accurate expiration dates and update in WIR.
  • Do not stockpile; order only what you need.
  • Use the Wisconsin COVID-19 Vaccine Exchange to reduce wastage and to assist DHS in monitoring statewide vaccine availability and supply.
Inventory management
  • Inventory status must be reconciled daily in accordance with your COVID-19 provider agreement. Update your inventory in WIR at the close of each business day to ensure that your physical inventory count matches your WIR inventory.
  • Stay aware of expiration dates and plan ahead to redistribute vaccine, if needed.
    • Mark the beyond-use date on the package or vial when changing storage temperature and note the beyond-use date and time once the vial is first punctured.
    • Monitor expiration dates weekly, rotate stock as needed, and follow a “first in, first out” strategy to manage inventory.
    • If nearing expiration, check posted manufacturer information for the most up to date expiration/extension information for Pfizer-BioNTech, Moderna, Novavax, and Johnson & Johnson COVID-19 vaccine lots.
    • Redistribute vaccine to other providers by posting COVID-19 vaccine on the Wisconsin COVID-19 Vaccine Exchange. Vaccine supply cannot be returned to DHS. It can only be redistributed to other enrolled providers.
  • Remove expired vaccine from the storage unit immediately, based on the latest expiration information. Do not give staff the opportunity to administer expired vaccine.
    • If expired vaccine is inadvertently administered, it is considered a vaccine administration error and requires remediation including a Vaccine Adverse Event Reporting System (VAERS) report, contacting the recipient to inform them of the error, and may or may not require revaccination based on the manufacturers’ guidance. See CDC's guidance on vaccine administration errors and deviations.
    • Vaccine disposal: dispose of the vaccine vial (with any remaining vaccine) and packaging as medical waste according to your facility’s policy. COVID-19 vaccine does not get returned to the state. Do not return vaccine in the thermal shipping container.
Secure disposal of vaccine vials and packaging

Due to the increased threat of fake or counterfeit vaccines, the Department of Defense has outlined recommended steps to properly dispose of empty vaccine vials and product packaging. The preferred method for disposing of these items are to treat vials and packaging similarly to medical waste by placing in red sharps containers.

Resources

Potential label errors

The printed information on COVID-19 vaccine packaging may be different from what will be stated on the emergency use authorization (EUA) factsheets. Always follow the information in the latest EUA factsheet over the printed vial label.

  • Pfizer (6 month-4 year) maroon cap vial labels and cartons may state that a vial should be discarded 6 hours after the first dilution. Results from recent stability studies will supersede the current vial label and support discarding the vaccine after 12 hours from the time of dilution.
  • Pfizer (6 month-4 year) maroon cap vial labels may state “Age 2y to <5y” or “Age 6m to <5y”. Carton labels may state “For ages 2 yrs to <5 yrs” or “For age 6 months to <5 yrs.” Vials with either printed age range can be used for individuals 6 months – 4 years old if the product is authorized for emergency use.
  • The Moderna vials with blue caps, purple label borders may state they are for “BOOSTER DOSES ONLY”, but they are authorized for primary doses in children ages 6−11 years and booster doses in adults ages 18 years and older.

You can print out this updated label information for Pfizer 6mo-4Y and Moderna 6Y-11Y COVID-19 vaccines and display them in your facility.

Temperature monitoring and data loggers

In 2021, CDC made allowances for COVID-19 vaccine providers who had difficulty obtaining Digital Data Loggers (DDLs) due to supply chain delays and shortages.

Now that the supply chain issues for DDLs have been mostly resolved, CDC is advising providers who do not have DDLs to obtain them now. While CDC understands that this process will take some time, they expect that all provider locations where COVID-19 vaccine is stored or administered, including during transport, have and appropriately use DDLs in their facilities for COVID-19 vaccines, in accordance with CDC’s Vaccine Storage and Handling Toolkit.

As providers look to purchase DDLs, be aware that you may not need an expensive cloud-based system. Some DDLs meeting CDC requirements can be purchased online starting at $50 to monitor one storage unit. Still, it is important to have DDLs as they are considered the gold standard when it comes to monitoring temperatures for all vaccines.

DDLs ensure temperature excursions are detected, including the length of time a temperature is out of range, thus making them one of the most advanced devices to ensure vaccines are stored correctly and protected from unnecessary waste. Having a DDL provides valuable data that can save vaccine, prevent ineffective vaccine from being administered, and prevent the need to revaccinate affected patients.

Communicate COVID-19 medical supply shortages and ancillary kit issues

To help ensure that all Wisconsin organizations involved in the COVID-19 response have the supplies needed, DHS is requesting that you notify us as soon as possible regarding any current or anticipated supply shortages.

Please provide the following information about your anticipated shortage or current supply difficulties:

  • Your entity category (hospital, FQHC, public health, long term care, etc.)
  • Contact information
  • Specific item description (for example, if it is a needle or syringe, indicate the exact size(s), or if it is a N95 respirator, indicate the exact manufacturer and model)
  • Anticipated or current shortage amounts

This information can be communicated to DHS by sending an email to dhsstockpile@dhs.wisconsin.gov with the subject line: Current/Anticipated Supply Shortage.

Reporting ancillary kit deficiencies

Vaccinators are encouraged to immediately report any issues with equipment in the ancillary kits that are shipped with their federal vaccine orders. Please be prepared to provide photos, lot number, order number, date ordered, and dates received when filing a report for a deficient ancillary kit.

  1. Report ancillary kit issues and deficiencies to McKesson. Their customer service desk is charged with responding to problems and identifying trends.
  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.

Reporting vaccine wastage and increasing opportunities to vaccinate

Take every opportunity to vaccinate

The ultimate goal at this point in the vaccination effort must be “no wasted opportunity,” rather than “no wasted doses.”

DHS is asking vaccinators to become increasingly creative to find new opportunities to offer vaccine to individuals in ways they trust that builds vaccine confidence, including in smaller settings such as primary care visits. In doing so, we understand that vaccine wastage may increase.

When faced with situations in which the choice is between opening a vial for a few individuals and assuming waste or asking that individuals return another day, DHS encourages all vaccinators to prioritize vaccination. Every individual counts, and we need to leverage every opportunity to vaccinate to the fullest.

Vaccine wastage reporting process

Only report COVID-19 vaccine wastage to the Wastage Form, F-02768 if the doses expired per the actual expiration date.
  1. Check posted manufacturer information for the most up to date expiration/extension information for Pfizer-BioNTech, Moderna, Novavax, and Johnson & Johnson COVID-19 vaccines. Manage your vaccine inventory and update the expiration dates accordingly in WIR.
  2. If the doses are expired per the expiration date, fill out the Wastage Form, F-02768 for the COVID-19 vaccine that has passed its expiration date. These expired doses should not be reported in WIR.
  3. Email the Wastage form to the DHSCovidVaccinator@wi.gov and put “EXPIRED” in the subject line of the email.
Report all other COVID-19 vaccine wastage to WIR (but do not fill out a wastage form) if doses are:
  • Gone past the beyond-use date (BUD).
    • BUD is different from the expiration date and is defined as the amount of time allowed by the manufacturer for a vaccine to be used after being punctured, reconstituted, or moved from a freezer to a refrigerator.
      • Vial punctured, but not used in appropriate timeframe per manufacturer instructions
        • Enter as Doses Wasted in WIR with the Reason: Open Vial, Not all Doses Administered.
      • Unpunctured vial past its BUD
        • Enter these as Doses Wasted in WIR. Use the Reason: “Other” code and enter "BUD" in the description.
    • Do not replace the expiration date in WIR with the BUD.
      • Mark the BUD on the package or vial when changing storage temperature and note the beyond-use date and time once the vial is first punctured.
      • When vaccine expires per the BUD, it is entered as wastage in WIR.
      • See the COVID-19 Vaccine: Quick Reference Guide for more information about BUDs.
  • Unable to be drawn from a vial.
    • Enter these as Doses Wasted in WIR. Use the Reason: “Other” code and enter "only able to administer 'x' doses from vial" in the description.
    • Calculate waste by counting the total number of doses administered, regardless of volume or series, and subtracting this from the total number of identified doses in the vial. Standard doses per vial – number of vaccines administered = waste
      • For example, if you are only able to draw five doses from a Pfizer 12Y+ gray cap vial rather than six, enter one dose as wasted.
      • If a total of eight people were vaccinated with the Moderna 12Y+ red cap vaccine (two primary and six booster shots), enter two doses as wasted.
        • 10 doses per vial - 8 doses administered= 2 doses wasted.
        • Even though Moderna 12Y+ red cap vials can contain either 10 primary doses (0.5 mL), 20 booster doses (0.25 mL), or a combination of full and half doses, don't report wastage once 10 administrations of Moderna 12Y+ red cap occur regardless of dose sizes.
  • Spoiled due to temperature excursions.
    • The vaccines that were exposed to out-of-range temperatures must be labeled
      “do not use” and stored at the required temperature until further information on usability can be gathered or further instruction on disposition or recovery is received.
    • The temperature excursions must also be reported to the manufacturers. Moderna and Johnson & Johnson temperature excursions during shipment must be reported on the same day as delivery. The contact information is available on the bottom of our Pfizer, Moderna, and Johnson & Johnson webpages.
    • Never use the “Doses spoiled” code in WIR for COVID-19 vaccines as that data does not get reported to CDC. If doses are spoiled (exposed to temperature excursions), enter them as Doses Wasted in WIR. Use the Reason: Other code and enter “temperature excursion” in the description.
  • Not able to be used for any other reason.
    • If vaccine doses are left unused for any other reason, enter them as Doses Wasted in WIR. Use the Reason: “Other” code and write a brief description in the free text box.

    COVID-19 vaccine never gets returned to the state regardless of expiration date or wastage reason. It should always be disposed of per the facility’s policy.


    Refer to CDC's Identifying, Disposing, and Reporting COVID-19 Vaccine Wastage webpage for additional guidance. This waste management guidance should not be used for non-COVID-19 vaccines, which are covered under other CDC vaccination programs.

    Strategies to maximize vaccination and minimize dose wastage

    In order to reduce missed opportunities to vaccinate, minimize the number of unused expired doses, and manage expired doses correctly, CDC and DHS encourage providers to:

    • Vaccinate at every opportunity.
      • Vaccinate family members or friends who accompany patients to medical visits even if they are not established patients at the vaccinating practice.
      • Vaccinate every eligible person who presents at a vaccination site, even if it means puncturing a multidose vial to administer vaccine without having enough people available to receive each dose.
    • Bring vaccines to the people in smaller, trusted settings.
    • Promote your vaccination event and make sure it is shared with 211 and Vaccines.gov.
    • Stay aware of expiration dates and plan ahead to redistribute vaccine, if needed.
      • Mark the BUD on the package or vial when changing storage temperature and note the beyond-use date and time once the vial is first punctured.
      • Monitor expiration dates weekly, rotate stock as needed, and follow a “first in, first out” strategy to manage inventory.
      • If nearing expiration, check posted manufacturer information for the most up to date expiration/extension information for vaccine lots.
      • Be aware of steps needed to redistribute vaccine to other providers such as having a Redistribution Form on file and posting COVID-19 vaccine to be redistributed on Wisconsin COVID-19 Vaccine Exchange. Vaccine supply cannot be returned to DHS. It can only be redistributed to other enrolled providers.
    • Remove expired vaccine from the storage unit immediately, based on the latest expiration information. Do not give staff the opportunity to administer expired vaccine.
      • If expired vaccine is inadvertently administered, it is considered a vaccine administration error and requires remediation including a Vaccine Adverse Event Reporting System (VAERS) report, contacting the recipient to inform them of the error, and may or may not require revaccination based on the manufacturers’ guidance. Guidance on vaccine administration errors can be found in the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States.
      • Vaccine disposal: dispose of the vaccine vial (with any remaining vaccine) and packaging as medical waste according to your facility’s policy. COVID-19 vaccine does not get returned to the state. Do not return vaccine in the thermal shipping container.

    CDC does not recommend pre-drawing vials.

    If doses need to be pre-drawn:

    • Set up a separate administration station for each vaccine type to prevent medication errors.
    • Draw up vaccines at the clinic site or mass vaccination event on the day of the event. Do not draw up in advance or plan on transporting pre-drawn vaccine.
    • Each person administering vaccines should draw up no more than one multi-dose vial at one time.
    • Monitor patient flow to avoid drawing up unnecessary doses.
    • Pre-draw reconstituted vaccine into a syringe only when ready for administration.
    • If pre-drawn vaccine is not used within 30 minutes of being reconstituted, follow manufacturer guidance for storage conditions and time limits. See the COVID-19 Vaccine: Quick Reference Guide for more information about beyond-use dates when changing storage temperature and after first puncturing the vial.

    Resources

    Vaccine redistribution, transportation, transfers, and donation

    Useful tools and resources for vaccine redistribution

    Steps to redistribute vaccine

    Note: Organization refers to the provider listed on Form A, and location or site refer to the provider listed on Form B.

    1. Ensure a provider agreement (Form A and Form B) is on file and approved for your location.
      • If your location has a Pandemic PIN and has been ordering vaccine, this can serve as confirmation.
      • Otherwise, email DHSCovidVaccinator@wi.gov for confirmation.
    2. Ensure a Redistribution Form is on file and approved for your organization.
      • A COVID-19 vaccine provider organization only needs to fill out one Redistribution Form. Once the Redistribution Form is approved and on file, the organization can redistribute vaccine to other approved entities and locations. Check your email to see if you have gotten an approval email from dhscovidvaccinator@wi.gov or email DHSCovidVaccinator@wi.gov for confirmation.
      • Make sure your Redistribution Form includes the current Chief Medical Officer’s (CMO) and Chief Executive Officer’s (CEO) e-signature and matches your organization's Form A.
        • If you need to update the information on your Provider Enrollment forms, 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.
      • If your organization does not have a Redistribution Form on file, generate and submit a Redistribution Form on the COVID-19 Vaccinator Enrollment Tool. See the guide to filling out the COVID-19 vaccine Redistribution Form.
        1. Login to the enrollment tool using your DOA/Wisconsin Logon credentials.
        2. Locate the Redistribution Form at the bottom of the enrollment tool and complete it.
        3. Submit the Redistribution Form and wait for provider enrollment staff to reach out for corrections or with your approval email.
    3. While waiting for the approval of your Redistribution Form, find an enrolled COVID-19 vaccine provider to redistribute vaccine to using the Wisconsin COVID-19 Vaccine Exchange.
      • Complete the Offer Vaccine Form on the bottom right of the Vaccine Exchange page and click submit.
      • Refresh the page after submitting to see your entry placed.
      • If another vaccinator requests to use your vaccine, you will receive an email with contact information for next steps.
      • For more information, see the full announcement about the Wisconsin COVID-19 Vaccine Exchange.
      • If you need to remove your listing, please request the vaccine using the Request Vaccine Form, fill out the appropriate fields, enter in your row ID, and ask for zero doses. Click submit, then refresh the page. This will remove your listing.
    4. Once you have identified an enrolled COVID-19 vaccine provider to accept your vaccine, ensure the receiving location also has an approved provider agreement (Form A and Form B). Email the receiving location or DHSCovidVaccinator@wi.gov for confirmation.
    5. Once you have received approval for redistribution and partnered with a receiving provider, initiate an electronic transfer in WIR between your two organizations.
      • When setting up a transfer, the initiating provider chooses the organization the vaccine is going to, not the site. It is the responsibility of the receiving provider to make sure that the vaccine gets accepted into the correct COVID-19 configured site. For more guidance, see the Managing Transfers WIR training video.
    6. If you are receiving the transfer, make sure to accept the electronic transfer in WIR upon receipt of the shipment. This step will automatically add the vaccine to your inventory. Do not add the inventory manually.
    7. Redistribute any unused COVID-19 vaccine.
    8. If additional support is needed, please contact DHSCovidVaccinator@wi.gov.

    Transportation of vaccine in vials and predrawn syringes

    Ideally, vaccines should be delivered directly to the facility where they will be used. CDC does not recommend routine transport of vaccine vials. However, there may be circumstances where COVID-19 vaccine needs to be redistributed or transported. Examples of this are transportation to satellite, temporary, or off-site clinics, and programs at long-term care facilities.

    If vaccines must be transported:

    • Follow the routine vaccine storage and handling transport guidance outlined in CDC’s Vaccine Storage and Handling Toolkit. The COVID-19 vaccine addendum includes additional specifics for COVID-19 vaccines, including:
      • Vaccine must be transported in a stable storage unit and monitored with a digital data logger (DDL).
      • Use CDC’s transport temperature log to record temperatures and time in transport.
    • Transport vaccine in vials whenever possible. Partially used vials may be transported.
    • In the limited instances when the only option is to transport vaccine in a predrawn syringe, follow guidance for transporting predrawn vaccine in syringes provided in the USP COVID-19 Vaccine Toolkit: Operational Considerations for Healthcare Practitioners.
    • Any time spent in transport must be included in the beyond-use dates or times for the vaccine products.

    HRSA COVID-19 vaccine transfer process for Health Centers

    Health Resources & Services Administration (HRSA) has updated their guidance regarding Health Centers’ ability to transfer vaccines received through the HRSA Health Center COVID-19 Vaccine Program. Participating health centers may transfer HRSA-allocated vaccine to other health centers and vaccine providers, including partners not participating in the HRSA Health Center COVID-19 Vaccine Program.

    Enrollment and reporting requirements:
    • Vaccinators not participating in the HRSA Health Center COVID-19 Vaccine Program must be CDC-enrolled in order to receive vaccine transfers from participating health centers.
    • The vaccinator receiving the vaccine transfer is responsible for reporting the vaccine administration data to WIR.
    • The health center transferring the doses out of their inventory will not report vaccine administration for transferred doses in the weekly Health Center COVID-19 Survey, or in any other reporting system.
    Inventory management:
    • Both parties involved must update their inventory upon transfer.
    • The health center transferring the vaccine out of their inventory must zero out the transferred doses in the Vaccine Provider Order Portal (VPoP).
    • The recipient organization receiving the vaccine from the health center must add the transferred doses to their inventory in their applicable reporting system.

    Any interested health centers should reach out to HRSA Health Center COVID-19 Vaccine Program Support or call 877-464-4772, option 2 between 6 a.m. to 7 p.m. CT, Monday-Friday (except federal holidays). Additional information is available soon on the HRSA website in the Health Center COVID-19 Vaccine Program frequently asked questions (FAQ).

    Donating COVID-19 vaccines for research

    Many Wisconsin vaccinators have raised questions about donating vaccine (expired or not) for use in research. All requests for use of COVID-19 vaccine doses for research purposes must be submitted, reviewed, and approved by the U.S. Department of Health and Human Services (HHS). Any interested vaccinators should work through the National Institutes of Health’s (NIH) process to request use of COVID-19 vaccine doses for NIH-approved studies. Once NIH approves the research grant, then NIH submits the request for the needed COVID-19 doses to HHS for review and approval.

    International transfer and donation of COVID-19 vaccine

    As a COVID-19 vaccinator participating in the CDC COVID-19 Vaccination Program, you cannot transfer or donate COVID-19 vaccines allocated to you outside of the United States. Any international transfer or donation of COVID-19 vaccines must be undertaken by the federal government. As a reminder, all of the doses that have been provided to you have been allocated under the CDC COVID-19 Vaccination Program, which has stringent requirements for how such doses may be used. Such requirements apply to any COVID-19 vaccine (including refrigerated Johnson & Johnson vaccine, and frozen Moderna and Pfizer vaccine) regardless of storage location.

    Providers and partners based in the U.S. with questions regarding donating vaccine internationally should email CDC’s Distribution and Federal Programs functional box (eocevent551@cdc.gov). Inquiries from international partners may be referred to the Department of Health and Human Services Office of Global Affairs (OGAPETFlu@hhs.gov).

    If you have any questions regarding donating vaccine internally or domestically, please contact DHSCovidVaccinator@wi.gov.

    Preventing and reporting COVID-19 vaccine and vaccination card fraud

    COVID-19 vaccination cards have been stolen, fraudulently reproduced, and illegally sold to reflect full vaccination for someone who has not received a COVID-19 vaccine. There have also been reported incidents of stolen and lost vaccine vials. To address these issues, please consider the following strategies:

    • Always secure your vaccine and vaccination cards to protect them from inappropriate distribution.
    • Monitor both the inventory of vaccine and blank vaccination cards and keep them locked up when not being used. If you are unable to store the excess cards, offer them to your local health department, or as a last resort, destroy them.

    Learn how you can avoid vaccine scams and share this information with your patients. Communicate with patients so they are aware and attentive of fraudulent practices such as:

    • Requests for payment to get a vaccine, including deposits or fees.
    • Requests for payment or offers of money to enhance ranking for vaccine eligibility (such as, getting a better spot in line or on a wait list).
    • Offers to sell or ship doses of vaccine for payment.
    • Offers to purchase vaccine record cards containing personally identifiable information and offers of money to participate in a vaccine survey.

    Report suspected fraud and theft incidences to your local law enforcement agencies, the HHS Office of Inspector General, and/or the FBI as listed below:

    • HHS Office of Inspector General (1-800-HHS-TIPS or oig.hhs.gov)
    • Federal Bureau of Investigation Electronic Tip Form (tips.fbi.gov)

    Two guides were developed to provide points of distribution managers and organizers with information regarding potential physical threats and corresponding risk mitigation solutions. Local and tribal health departments can find these guides on the PCA portal.

     Frequently asked questions

    For questions about enrollment and training, please see the DHS COVID-19 Vaccine Provider Enrollment webpage. For more questions, visit CDC's COVID-19 Vaccine FAQs for Health Care Professionals.

    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 EUA-authorized 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-authorized 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?

    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 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 Wisconsin Department of Safety and Professional Services for additional information.

    Q: Will a Vaccine Information Statement (VIS) be available for COVID-19 vaccines?

    A: VIS’s are information sheets produced by the CDC that explain both the benefits and risks of a vaccine to vaccine recipients. COVID-19 vaccines that are authorized under an emergency use authorization (EUA) have a fact sheet produced by FDA which contains similar information to a VIS. The fact sheets and their translations are available on the FDA webpage.

    Q: Can COVID-19 vaccines be administered to individuals that do not reside in Wisconsin?

    A: Anyone can get vaccinated for free — even if they cannot provide proof of residency, do not have a valid state identification, or do not have insurance. Vaccinators cannot require people to provide an ID for vaccinations.

    Q: Does CDC or the state provide a template consent form?

    A: There is no special federal or state requirement for consent forms for COVID-19 vaccines, so the CDC and DHS are not intending to provide templates. Vaccinating entities are free to use a consent form they have developed for their own needs. There is a requirement to provide the emergency use authorization fact sheet for the specific COVID-19 vaccine to each person administered COVID-19 vaccine.

    There is an EUA for medical providers too. Please consult your legal counsel if you have questions regarding the consent process at your site or facility. There is a screening form available from CDC.

    Q: Is parental consent required for individuals under the age of 18 to receive a COVID-19 vaccine in Wisconsin?

    A: According to the CDC, state laws establish vaccination requirements for school-aged children. In Wisconsin, the age of majority is 18 years of age, unless emancipated. Therefore, all unemancipated individuals under 18 years of age require parent or guardian consent to receive the COVID-19 vaccine.

    Wis. Stat. § 48.979 allows a parent to delegate their decision-making responsibilities for their child. This statute has been interpreted to authorize the administration of the COVID-19 vaccine when the legal parent or guardian has given verbal or written consent. This statue does not mandate a vaccinator to accept written or verbal consent but makes it permissible for the vaccinator to accept these forms of consent should they choose to do so. DHS does not have a sample consent form for vaccinators to use for this purpose. Vaccinators are encouraged to work with their own legal counsel regarding methods of consent for vaccinating minors in their clinic.

    Questions about vaccine delivery and redistribution

    Q: Are there any restrictions 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 in the morning and one in the afternoon (for selected days).
    • You must have a one-hour spacing, between the morning (first) and afternoon (second) delivery windows:
      • 7 a.m. – noon
      • 1 – 4 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: 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: 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: How will my organizations be able to redistribute the COVID-19 vaccine?

    A: See the steps for redistributing vaccine above. Only COVID-19 providers with approved provider agreements (Form A and Form B) are allowed to receive and redistribute COVID-19 vaccine. DHS has developed the Wisconsin COVID-19 Vaccine Exchange where providers can list and find COVID-19 vaccine doses. Vaccinators are responsible for working together to redistribute the COVID-19 vaccine. This includes arranging the transportation of doses, completing the transfer in WIR, and ensuring both entities have the required forms submitted and approved.

    Q: Where can I find the Redistribution Form?

    A: The Redistribution Form may be found on the COVID-19 Vaccine 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?

    A: Yes. Effective 2022, Wisconsin Department of Health Services is now requiring an approved Redistribution Form for all enrolled vaccinator organizations. The Redistribution Form serves as an agreement from the provider to comply with all COVID-19 vaccine redistribution agreement requirements.

    The Redistribution Form should match your organization’s Form A and include current information in the following fields:

    • Organization Name
    • Medical Director/Chief Medical Officer
    • Chief Executive Officer (CEO) or Chief Financial Officer (CFO)

    If you need to update the information on your Provider Enrollment forms, 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: Do I need to have an approved COVID-19 Vaccine Provider Agreement to redistribute vaccine?

    A: Yes, you must have an approved COVID-19 Vaccine Provider Agreement (Form A, Form B, and Redistribution Form) on file in order to redistribute vaccine. The CMO and CEO/CFO must be the same on your Form A and Redistribution Form and must be kept up to date.

    Q: Does the reference number in the lower right corner of 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 ideally should have the same reference number as your Forms A and B.

    If they are not the same reference numbers, or you do not know your Form A and B reference number, contact DHSCovidVaccinator@wi.gov.

    If you do not know the COVID-19 Vaccine Enrollment Tool login information of the individual who originally submitted your enrollment paperwork, kindly give advanced notice to DHSCovidVaccinator@wi.gov prior to submitting any new forms.

    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 do not already have a Redistribution Form on file, submit one via the COVID-19 Vaccine Enrollment Tool. You will receive confirmation when the form has been processed, typically within one to two business days. Once approved, you can then post vaccine to the Wisconsin COVID-19 Vaccine Exchange. If you have any questions or want to check the status of your Redistribution Form, please contact DHSCovidVaccinator@wi.gov.

    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 email approval from DHS. If you have any questions or want to check the status of your Redistribution Form, please contact DHSCovidVaccinator@wi.gov.

    Q: What if I already completed a Redistribution Form?

    A: If you have already submitted a redistribution Form B but have not received your emailed approval, contact DHSCovidVaccinator@wi.gov regarding the status of your form.

    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?

    A: The COVID-19 vaccine is provided to Wisconsin by the Federal Government and therefore must be administered at no out-of-pocket cost to all recipients.

    COVID-19 vaccine providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient, such as:

    • Vaccine recipient’s private insurance company
    • Medicare or Medicaid reimbursement

    However, providers may not:

    • Administer COVID-19 vaccine at any out-of-pocket cost to the recipient.
    • Deny anyone vaccination based on the vaccine recipient’s coverage status or network status.
    • Charge an office visit or other fee if COVID-19 vaccination is the sole medical service provided.
    • Require additional medical services to receive COVID-19 vaccination.
    • Seek any reimbursement, including through balance billing, from the vaccine recipient.
       

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

    A: 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.

    Questions about site visits

    As a recipient of CDC COVID-19 supplemental funding, DHS is required to conduct site visits to enrolled COVID-19 vaccine providers who receive state allocated vaccine. Regional DHS staff will visit vaccine providers to ensure that vaccine is being stored, handled, administered, and documented in accordance with state and federal policies, and support vaccinators by providing technical assistance, updated resources, and education.

    Q: Why is our site being visited?

    A: All recipients of Centers for Disease Control and Prevention COVID-19 vaccination supplemental funding (January 2021), including the State of Wisconsin, must conduct quality assurance site visits to enrolled vaccination providers who receive state allocated vaccine. Site visits are also required for hubs, or “depots,” which are locations used to store or redistribute COVID-19 vaccine to multiple locations.

    Site visits are an opportunity for DHS to support vaccinators by providing technical assistance, updated resources, and education regarding vaccine administration, storage and handling, and other relevant materials.

    The purpose of site visits is to:

    • Assess vaccinator adherence to program guidelines and requirements.
    • Ensure vaccines are received and administered in the proper manner.
    • Identify and address challenges needing technical assistance, training, and additional follow-up.
    • Support vaccinators by providing updated resources and education regarding vaccine administration, storage and handling, and other relevant resources.

    Q: Will my site know ahead of time when a site monitor is coming?

    A: Yes, a DHS site monitor will contact the Primary and Back-up Coordinators (as listed in the Wisconsin Immunization Registry) via email one to two weeks in advance of the site visit to schedule a day and time, discuss site visit requirements (such as access to vaccine storage units), and answer any questions you may have.

    Q: What will a typical site visit include?

    A: Site visits may last up to 3 hours.

    During the visit, the site monitor(s) will review the following items with the vaccinating site:

    • Provider registration information
    • Billing, documentation of vaccine administration, and vaccine recipient communications
    • Vaccine storage and handling
    • Vaccination procedures
    • Ancillary supply kits

    Q: What if our site has no COVID-19 vaccinations scheduled for the day of the site visit?

    A: An important part of each site visit is observation of COVID-19 vaccination preparation, as well as the administration of a vaccine to a patient. Your site monitor will work with you to schedule the site visit during a time when you expect to be preparing and administering vaccine. Additionally, you will receive a phone call or email one to two days before the scheduled site visit to verify that you will have COVID-19 vaccine on-site and still anticipate being able to prepare and administer at least one vaccine during the site visit.

    If the site monitor is not able to observe vaccine preparation and administration, the site visit may need to be rescheduled or a follow-up visit conducted.

    Q: Will our site be visited if we are no longer providing COVID-19 vaccinations?

    A: At this time, per CDC guidelines, only sites that are currently providing COVID-19 vaccinations will be visited.

    Q: How will the site monitor review storage and handling?

    A: The site monitor will review guidelines for storage and handling procedures verbally with providers. Additionally, the site monitor will need access to storage units, temperature monitoring devices, temperature logs, and electrical outlets, and may ask to see other relevant parts of your site’s storage facilities or handling procedures.

    Q: Are the program requirements that the site monitors assess the same as the Vaccines for Children (VFC) program requirements?

    A: No, the site visits discussed here are only for the COVID-19 Vaccination Program. Though the VFC and COVID-19 Vaccination programs are both federal government programs, they each have distinct requirements based on the associated funding legislation. For this reason, the provider agreements remain separate, and VFC providers must sign and adhere to the requirements of the CDC COVID-19 Vaccination Program Provider Agreement in order to receive and administer COVID-19 vaccines.

    Review the CDC's comparison of the VFC and COVID-19 Vaccination Program to assist in understanding the differences in the programs’ requirements.

    Q: What happens if a site monitor finds a non-compliant practice?

    A: Site visits are intended as an opportunity for discussion, education, and technical assistance. If your site monitor has questions or concerns during the site visit, the site monitor will address them with you directly while on-site and can provide resources for best practices. The site monitor and provider location staff should agree on a follow-up plan and timeline to address any issues with adherence to requirements or opportunities for improvement.

    Following the visit, the site monitor will send an email to the provider, summarizing the site visit findings, action items for the provider, and follow-up plan if needed.

    If the non-compliant practice appears to meet the definition of Fraud or Abuse, a referral will be made to the State and Federal Office of the Inspector General.

    Q: Who can I contact if I have additional questions?

    A: If you have specific questions regarding the upcoming quality assurance visits, please contact the DHS COVID-19 Vaccine Site Monitor email box at DHSCOVIDVaccineSiteMonitor@WI.gov.

    Thank you for your continued work 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: August 10, 2022

    211 Wisconsin

    Call 211 or 877-947-2211 to get referrals for thousands of services across Wisconsin. For COVID-19 questions, text COVID to 211-211. Language assistance is available.

    Resilient Wisconsin

    Get help learning how to manage stress and adapt to change with services and support from organizations across the state.

    Helpful resources

    Find help with housing, income, food, employment, health care, mental health concerns, safety at home, and more—in multiple languages.