COVID-19: General Guidance for Vaccinators

Weekly webinars

Webinars for stakeholders and vaccinators are Tuesdays from 11 a.m. to noon. There will not be a webinar on September 7, 2021.

Register for the meeting series. Once you register, you can use the same Zoom link every week.

Watch recordings of past webinars.

Vaccinators are the front line of defense to stopping the spread of COVID-19. This page has critical guidance about safely and effectively storing, handling, and administering the COVID-19 vaccine.

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

Questions?

Email dhscovidvaccinator@wi.gov.

 

Updates:

  • September 15, 2021:
  • August 30, 2021:
    • See guidance on the interchangeability of COVID-19 vaccines under vaccine administration guidance.
    • Providers can now receive additional payments for administering COVID-19 vaccines to Medicare beneficiaries in smaller group homes, assisted living facilities, and other group living situations. See more information under vaccine administration guidance.
    • The Association of State and Territorial Health Officials (ASTHO) updated their side-by-side comparison of all the guidance updates for each of the COVID-19 vaccines, available under vaccination clinical guidance resources.
  • August 25, 2021:
    • The COVID-19 vaccines available for ordering will continue to change over the next few weeks. Please review the most recent email sent about vaccine configurations before ordering vaccine.
    • Public health and medical experts from the U.S. Department of Health and Human Services (HHS) released a statement on the Administration’s plan for COVID-19 booster doses for the American people, pending FDA authorization and ACIP recommendation. See more information under vaccination clinical guidance.
    • The COVID-19 vaccine lot number and expiration date files are available for use in vaccine administration and inventory management. These files include COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturers.

 Vaccine administration guidance

Useful tools and resources:

Interchangeability of COVID-19 vaccine products

CDC released the following guidance on the interchangeability of COVID-19 vaccine products:

  • Every effort should be made to determine which vaccine product was received as the first dose to ensure completion of the vaccine series with the same product.
  • In exceptional situations in which the mRNA vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series.
  • In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose (up to six weeks) to receive the same product than to receive a mixed series using a different product.
  • If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. Such persons are considered fully vaccinated against COVID-19 two weeks after receipt of the second dose of an mRNA vaccine.

Wisconsin Immunization Registry (WIR) highlights

WIR COVID-19 vaccine schedule change

In WIR, the COVID-19 vaccine schedule has been modified; an individual that receives either Moderna or Janssen COVID-19 vaccine after age 12, but before age 18, will now show as invalid since those vaccines are not yet authorized for that age group. View the full message here.

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, 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.
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. It should also be noted that the mass vaccination section of WIR will soon have questions to collect race and ethnicity data too.

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

COVID-19 vaccine billing practices

The COVID-19 Vaccination Program’s primary goal is to administer COVID-19 vaccine safely, quickly, and equitably to all populations across the state. In order to do this, it is critical that all individuals 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 and cannot charge a co-payment or 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:

  • 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 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
    • Health Resources and Services Administration (HRSA) COVID-19 Uninsured Program for non-insured vaccine recipients. See information sheets for patients (in English and Spanish) and providers (in English and Spanish).
    • HRSA COVID-19 Coverage Assistance Fund covering costs of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost sharing.
  • May not seek any reimbursement, including through balance billing, from the vaccine recipient

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.

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.

More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available at https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.

More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.

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

Guidance for community-based vaccination

As the supply of vaccine outweighs the demand for vaccine, it is time to move towards more targeted and flexible community-based vaccination strategies, like pop-clinics in churches 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.

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.
  • 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.
  • 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 providers eligible to administer COVID-19 vaccine under the PREP Act

Joint guidance on the Public Readiness and Emergency Preparedness (PREP) Act March 11, 2021 Seventh Amendment was issued from:

  • Wisconsin Department of Health Services (DHS)
  • Wisconsin Department of Safety and Professional Services (DSPS)
  • Wisconsin Veterinary Examining Board (VEB)

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

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

DSPS and DHS have deemed that the following health care professionals who hold an active credential under the law of any state, or hold a credential that has expired, become inactive, or lapsed within the last five years and was in good standing when it expired, lapsed, or became inactive, and who meets the all requirements under the PREP Act Seventh Amendment, are authorized under the PREP Act Seventh Amendment to administer U.S. Food and Drug Administration (FDA) authorized, approved, or licensed COVID-19 vaccines in Wisconsin.

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

  • Physicians
  • Registered nurses
  • Licensed practical nurses
  • Advanced practice registered nurses
  • Pharmacists
  • Pharmacy interns
  • Midwives
  • Physician assistants
  • Respiratory therapists
  • Dentists
  • Podiatrists
  • Optometrists
  • Emergency medical services providers (EMT, AEMT, EMT intermediate, or paramedic)
All professionals and students

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

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

Everyone administering COVID-19 vaccines must complete the DHS required training in the training section below prior to becoming a COVID-19 vaccinator.

Health care students

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

Veterinary students

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

Licensed veterinarians

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

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

Doses per vial and interval between doses

Doses per vial and interval between doses

Vaccine Doses per vial Volume Number of doses Dose interval
Pfizer 6 0.3 mL 2 3 weeks (21 days)
Moderna 10-15 0.5 mL 2 1 month (28 days)
Johnson & Johnson 5 0.5 mL 1 N/A
Doses per vial

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

Interval between mRNA doses

The second dose of Pfizer and Moderna vaccines should be administered as close to the recommended interval as possible, but not earlier than recommended (for example, three weeks [Pfizer] or one month [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 it is not feasible to adhere to the recommended interval and a delay in vaccination is unavoidable, the second dose of Pfizer and Moderna COVID-19 vaccines may be administered up to six weeks (42 days) after the first dose.

 Vaccination clinical guidance

Useful tools and resources:

Booster doses

Public health and medical experts from the U.S. Department of Health and Human Services (HHS) released a statement on the Administration’s plan for COVID-19 booster doses for the American people, pending FDA authorization and ACIP recommendation.

DHS is currently developing plans as to how this will be applied and implemented in Wisconsin, as well as what that means for our vaccinators, partners, and the public. More details will be shared as they become available.

Differentiating additional and booster doses

An “additional dose” is recommended for people who may not have received adequate protection from their initial vaccine series. For example, studies show some people who have weakened immune systems don’t always build the same level of immunity after vaccination the way non-immunocompromised people do. People who are moderately to severely immunocompromised are recommended to get an additional dose of an mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna) to increase their immune response so they have protection against COVID-19.

A “booster dose” is a supplemental vaccine dose given to people when the immune response to a primary vaccine series is likely to have decreased over time. At this time, booster doses have not been recommended. The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration continue to review evidence and data as it is available about whether or when booster doses for the broader U.S. public may be needed, and will update guidance as more information becomes available.

Additional doses for people who are moderately to severely immunocompromised

On August 12, 2021, FDA modified the emergency use authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize an additional dose of an mRNA COVID-19 vaccines for people who meet the criteria of being considered moderately to severely immunocompromised. Due to insufficient data, the EUA amendment for an additional dose does not apply to individuals who received Johnson & Johnson (Janssen) COVID-19 vaccine as a primary series. 

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

Recipients can be guided to DHS's webpage about the additional dose or CDC’s webpage for immunocompromised individuals for more information. 

Summary

  • Eligibility: Please only administer Pfizer and Moderna COVID-19 vaccines to individuals who have completed their initial mRNA COVID-19 vaccine series and have specific medical conditions or receiving medical treatments that cause them to be moderately to severely immunocompromised (further defined below).
    • The Johnson & Johnson COVID-19 vaccine Emergency Use Authorization has not been updated. At this time, individuals who have received a single-dose of Johnson & Johnson COVID-19 vaccine cannot receive an additional dose of COVID-19 vaccine (neither an mRNA vaccine nor a Johnson & Johnson vaccine). FDA and CDC are actively working to provide additional guidance on this issue.
    • Clinicians may only administer the vaccine as allowed in the emergency use authorizations.
  • Verbal attestation: Do not ask for proof that the vaccine recipient is immunocompromised. We do not want additional barriers for this vulnerable population to access a needed additional dose. As part of screening, you may use a patient’s verbal attestation as proof of qualification for an additional dose. DHS does not recommend the use of written attestation forms.
  • Timing: The additional dose may be administered at minimum 28 days after the initial mRNA COVID-19 vaccination series. There is no maximum days between doses. Timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies to optimize both the patient’s medical condition and response to vaccine.
  • Interchangeability of vaccines: The same COVID-19 vaccine product should be used for all doses. If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered.
  • Age groups: The age groups authorized to receive the additional dose are unchanged from those authorized to receive the primary vaccination series:
    • Pfizer-BioNTech: for individuals 12 years and older
    • Moderna: for individuals 18 years and older
  • Additional precautions: Counsel people who are immunocompromised about the potential for a reduced immune response even after their additional mRNA COVID-19 vaccine dose. Please reinforce the need for immunocompromised people to continue to follow current prevention measures (including wearing a mask and physical distancing).

Close contacts of immunocompromised people who are not yet fully vaccinated should also be strongly encouraged to be vaccinated against COVID-19.

Who can receive an additional dose of mRNA vaccines?

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 (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids (i.e., ≥20mg 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.

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.

Recommendations for COVID-19 vaccination during pregnancy

CDC and DHS are strengthening the recommendation for COVID-19 vaccination during pregnancy. A new 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.

CDC and DHS recommend that pregnant people should be vaccinated now against COVID-19 if they have not yet received a COVID-19 vaccine. COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant, breastfeeding, or trying to get pregnant now or might become pregnant in the future.

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.

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 a new 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 12 years and older, including people who are pregnant, breastfeeding, or trying to get pregnant now or might become pregnant in the future.
    • Previous language for reference: Pregnant people are eligible and can receive a COVID-19 vaccine.
  • 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 article:
    • 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 12 years of age 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 16 years of age 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.

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.

With influenza season approaching, CDC recognizes there may be compelling logistical advantages to offering patients COVID-19 and influenza vaccines on the same day, and you may encourage patients to receive these on the same day.

When deciding whether to co-administer another 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
  • 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.

Reminder: Pfizer COVID-19 vaccine is authorized for those aged 12 years and older, while Moderna and Johnson & Johnson COVID-19 vaccines are authorized for those aged 18 years and older. Each COVID-19 vaccine may be co-administered with routine vaccines within the parameters of their authorized age groups.

People vaccinated with COVID-19 vaccines not authorized in the U.S.

CDC’s clinical considerations for COVID-19 vaccines webpage has been updated with guidance about people vaccinated with COVID-19 vaccines not authorized in the U.S.

Some people may have received a COVID-19 vaccine that is not currently authorized in the U.S. No data are available on the safety or efficacy of receiving a COVID-19 vaccine currently authorized in the U.S. after receipt of a non-FDA-authorized COVID-19 vaccine. However, in some circumstances people who received a COVID-19 vaccine not currently authorized in the U.S. may be offered revaccination with an FDA-authorized vaccine:

COVID-19 vaccines not authorized by FDA but authorized for emergency use by the World Health Organization (WHO)

  • People who completed a COVID-19 vaccination series with a vaccine that has been authorized for emergency use by WHO do not need any additional doses with an FDA-authorized COVID-19 vaccine.
  • People who are partially vaccinated with a COVID-19 vaccine series authorized for emergency use by WHO may be offered an FDA-authorized COVID-19 vaccine series. This means that the individual should receive a first and second dose of the provider’s offered vaccine manufacturer.

COVID-19 vaccines not authorized by FDA or not authorized for emergency use by WHO

  • People who completed or partially completed a COVID-19 vaccine series with a vaccine that is not authorized by FDA or not authorized for emergency use by WHO may be offered an FDA-authorized COVID-19 vaccine series. This means that the individual should receive a first and second dose of the provider’s offered vaccine manufacturer.
  • Administration of an FDA-authorized COVID-19 vaccine in these people should comply with all conditions of use specified under the EUA for the vaccine being used. The minimum interval between the last dose of a non-FDA authorized vaccine and an FDA-authorized COVID-19 vaccine is 28 days.
FDA and WHO authorized vaccines

As of June 11, 2021, FDA has authorized the following COVID-19 vaccines for emergency use:

  • Pfizer-BioNTech COVID-19 vaccine
  • Moderna COVID-19 vaccine
  • Janssen (Johnson & Johnson) COVID-19 vaccine

As of June 11, 2021, WHO has listed the following COVID-19 vaccines for emergency use:

  • Pfizer-BioNTech COVID-19 [mRNA] vaccine, also known as Comirnaty, Tozinameran, or BMT162b2
  • AstraZeneca-Oxford COVID-19 [recombinant] vaccine also known as Vaxzevria, COVISHIELD (manufactured by the Serum Institute of India), ChAdOx1-S, or AZD1222
  • Janssen (Johnson & Johnson) COVID-19 [recombinant] vaccine, also known as Ad26.COV2-S
  • Moderna COVID-19 [mRNA] vaccine, also known as mRNA-1273
  • Sinopharm COVID-19 [inactivated Vero cell] vaccine, also known as Beijing Institute of Biological Products Co., Ltd. (BIBP)
  • Sinovac COVID-19 [inactivated Vero cell] vaccine, also known as CoronaVac

For the most up-to-date information about vaccines that have received WHO emergency use listing (EUL) and prequalification (PQ), please refer to the Status of COVID-19 Vaccine within WHO EUL/PQ evaluation process.

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.
  • Utilizing VaxText, a free text-messaging platform that providers can offer to their patients. Patients can opt in to conveniently receive text message reminders to get their second dose of COVID-19 vaccine. VaxText offers the added benefit of reminding patients to sign up for v-safe, a tool that allows people to report adverse outcomes following vaccination.

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

 

 Storage and handling guidance

Useful tools and resources:

Communicate COVID-19 medical supply shortages

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.

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.

Vaccine ordering process

Below are the guidelines and instructions for ordering Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccine; minimum vaccine ordering amounts; and timelines for order processing, delivery, and pick-up.

Ordering process steps

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

Johnson & Johnson direct shipping   

As of September 10, Wisconsin is again able to order Johnson & Johnson COVID-19 vaccine from the federal government. There are currently no allocations or order caps for this vaccine.

Please be good stewards of this important public health resource:

  • Use what you currently have on hand.
  • Continue to first check in the Wisconsin COVID-19 Vaccine Exchange prior to ordering additional Johnson & Johnson in the Wisconsin Immunization Registry (WIR).
  • Order in small quantities in WIR when you need more doses.   
  • Ensure that you have updated information on www.vacines.gov so folks seeking Johnson & Johnson can easily find where it is being offered.
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 could 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, 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, completing the transfer in WIR, and arranging the transportation of doses according to storage and handling guidelines.
Step 2: For additional vaccine, order COVID-19 vaccine through WIR using the following steps.

As the CDC offers new configurations and phases out existing products, the COVID-19 vaccines available for ordering in WIR will continue to change over the next few weeks. Please review the most recent email sent about vaccine configurations before ordering vaccine.

 

Reminders:

  • Please ensure your primary contact information in WIR is current as this will be the person that will be contacted if there are any concerns with the order. If you need to update this information, please email the new information to dhscovidvaccinator@wi.gov.
  • Vaccines for Children (VFC) and Vaccines for Adults (VFA) providers must order COVID-19 vaccines separately from all other vaccines. If you order COVID-19 vaccines and pediatric/adult vaccines in the same vaccine order, your COVID-19 vaccine order will be denied.
  • If you ordered your COVID-19 vaccines separately, yet still see a COVID-19 vaccine order marked as denied, it is possible that a regional hub is fulfilling the order. You will receive notification from state staff when this is the case to avoid confusion.
  • If you have any questions, need assistance while placing an order, or want to check on the status of your order, please email dhscovidvaccinator@wi.gov.

Step 1: Log into WIR using your ORG Code, Username and Password, and click on Manage Orders on the left side menu bar.

Screenshot inventory menu

Step 2: From the Manage Orders screen, verify your site information.

Screenshot showing how to manage orders by choosing the correct site name from the Initiating Site dropdown menu, making sure your delivery days and hours are correct, and clicking on the edit button if you need to make changes before creating the order.

  1. Choose the correct site name from the Initiating Site drop-down menu (1).
  2. Next, check to make sure your delivery days and hours are correct, and click on the edit button if you need to make changes (2).
  3. Once everything is correct on this screen, click Create Order (3).

Step 3: After clicking Create Order, you will arrive at the Provider Inventory Review screen. Here you will review and update your inventory. It is a WIR requirement that you submit accurate inventory with each order.

Screenshot Provider Inventory Review

  1. First, check that the correct site is showing in the drop-down menu. If not, you will need to go back to the Manage Orders screen to change it.
  2. Next check the inventory listed against your physical inventory for each vaccine listed – not just the vaccines you plan to order. If you need to make a correction to the listed inventory, click on Correct Inventory, and make the changes.
  3. When your inventory is correct, click Continue.

Step 4: Verify you are in the correct screen.

  • If you only receive COVID-19 vaccine from the state, you will see the following order screen with only "Special Section of Orderable Vaccines from State."

Screenshot create order

  • If you receive COVID-19 vaccine and pediatric or adult vaccines through the VFC or VFA programs, you will see the following order screen with two sections: "Special Section of Orderable Vaccines from State" and "Pediatric Vaccine (through age 18) from State."
    • If you will be ordering COVID-19 vaccines in addition to pediatric and/or adult vaccines, COVID-19 vaccines must be ordered separately from all other vaccines. If an order is received that contains both COVID-19 vaccines and pediatric vaccines, it will be denied. In this case, two orders would need to be submitted – one for the COVID-19 vaccines, and one for the pediatric vaccines.

Screenshot create order

Step 5: Enter the number of doses desired in the # Doses field. Click Submit Order to order vaccines.

Screenshot create order

  • All orders will be filled based on the manufacturer’s established package sizes. If you order outside of the manufacturer established package sizes, our staff will fill your order with the closest size available, and you may not receive the exact number of doses you ordered. For example, if you request 40 doses of Pfizer, you will only receive 30 doses. If you request 80 doses of Johnson & Johnson, you will receive 100 doses. See more about minimum vaccine ordering amounts and increments in the table below.
  • DHS has received reports of people being put on a waiting list, up to two months, to receive a COVID-19 vaccine. Please ensure your supply allows you to vaccinate on request, or connect people with a partner who can vaccinate on request. If you have questions or concerns about receiving vaccine supply, please contact DHSCOVIDVaccinator@dhs.wisconsin.gov. DHS also strongly encourages vaccinators to accommodate walk-in appointments. Review our guidance document about walk-in clinics and other useful resources on DHS’ COVID-19: Vaccine Partner Resources webpage.

Step 6: Track the status of your order.

  • After you click Submit Order, you will be returned to the Manage Orders screen. Your order will show at the bottom of the screen in the Order List as Pending.
    • If an order is in Pending Status, you can make changes to it. To make a change, click on the Pending link to return to the Create Order screen and make the necessary changes.

Screenshot current order list, status pending

  • Once staff begin processing your order, it changes from Pending to In Progress. You cannot make any changes to an order once it is in the In Progress status.

Screenshot in progress

  • Your order will either be:
    • shipped via McKesson or directly by the manufacturer, or
    • transferred and delivered by a hub. This will appear as “Denied” in WIR. See the next step for more information.
  • Learn more about order delivery timelines below.

Step 7: If your order was denied, check your email to make sure it is not being transferred by a hub.

  • If your order is being transferred by a hub, you will receive an email explaining that the hub will be delivering your vaccine and to disregard the denial. In order for hub to transfer vaccine to providers, your order must be taken out of the WIR order queue. If you see this email, you will still get your vaccine.
  • If you receive a denial but you do not receive an email notification, your order may have been denied for another reason. Email dhscovidvaccinator@wi.gov for more information or assistance.

Step 8: Once you receive your order, make sure to go to Manage Transfers in WIR to accept your order and automatically add it to your inventory.

Minimum Vaccine Ordering Amounts

Reminder: As the CDC offers new configurations and phases out existing products, the COVID-19 vaccines available for ordering in WIR will continue to change over the next few weeks. Please review the most recent email sent about vaccine configurations before ordering vaccine.

 

Vaccine Type Minimum Amounts
Pfizer

Increments of 30, 150, or 1170 doses.

If you order:

  • Quantities between 30 and 120 doses, orders will be delivered in increments of 30 doses.
  • Quantities between 150 and 1170 doses, orders will be delivered in increments of 150 doses.
  • Quantities greater than 1170 doses, orders will be delivered in increments of 1170.

This means you will only be able to receive the following quantities: 30, 60, 90, 120, 150, 300, 450, 600, 750, 900, 1170, or 2340 doses, or more.

Providers are encouraged to plan ahead, order, and store what they can use in 31 or 45 days.

Note: Order increments of 450 doses and quantities less than 30 doses are no longer available. Order increments of 1170 doses have been re-introduced.

In order to support more streamlined hub delivery and take advantage of the ability to store thawed vaccine up to one month (31 days) and unopened trays up to 45 days (14 days at 2-8 C and one month at refrigerated temperatures), hubs no longer deliver Pfizer in quantities less than 30 doses. If you place an order for less than 30 doses, your order will be denied.

Moderna Increments of 140 or 100 doses. Note: Order increments of 100 doses are only returning for a limited time, starting August 19, 2021.
Johnson & Johnson Increments of 100 doses.

 

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.

Order delivery timelines

Orders will be processed daily Monday through Friday based upon orders submitted by noon (12 p.m.). Vaccine orders submitted after noon will be held and processed the following day. Orders submitted after noon on Friday will be held until Monday.

Below are minimum, earliest expected delivery timelines based upon order submission. Hubs may be able to fulfill requests earlier based upon staff availability. Direct ship orders may be subject to delays based upon weather or other factors outside of the state’s control. State holidays will also impact all delivery schedules.

All Moderna and Johnson & Johnson orders will be fulfilled by direct ship to the provider. Providers will receive an automated confirmation email from the shipper confirming delivery.

Pfizer orders of full trays (1,170 doses) will be direct shipped at ultra-low temperatures. All other Pfizer orders will be delivered from hubs at refrigerated temperatures. For hub deliveries, providers will be contacted by their regional manager to confirm delivery.

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
  Moderna or Johnson & Johnson Pfizer
Direct Ship Direct Ship Hub Delivery
Monday Wednesday/Thursday Thursday Wednesday
Tuesday Thursday/Friday Friday Thursday
Wednesday Friday/Monday Monday Friday
Thursday Monday/Tuesday Monday Monday
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.

Reporting vaccine wastage and increasing opportunities to vaccinate

As demand for vaccine across the state continues to soften, we are 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.

Vaccine wastage reporting process

As of May 25, 2021, the following types of vaccine wastage must be reported in the following ways.

COVID-19 vaccine wastage that must be reported in WIR, but does not need a Wastage Form:
  • Note about codes for wastage reasons in WIR:
    - “Other” code: In the future, DHS is working on an enhancement to have a field for a “Description” to accompany the “Other” code. It will allow you to enter, for example, “Expired – past BUD date,” or “Pfizer – only five of six doses.” More to come. For now, please use the “Other” code for these scenarios. DHS will notify vaccinators when this functionality is available.
    - “Doses Spoiled” code: As a reminder, you should never use the “Doses spoiled” code in WIR for COVID-19. If there are doses spoiled of COVID-19 vaccine, it should always be entered as wastage per CDC guidance.

    Vaccine past its beyond-use date (BUD)
    • Vial punctured, but not used in appropriate timeframe per manufacturer instructions
      • Enter as Doses Wasted – Reason: Open Vial, Not all Doses Administered
    • Unpunctured vial past its BUD
      • Enter as Doses Wasted – Reason: Other
    • Do not change the expiration date in WIR.
      • 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.
  • Required number of doses not able to drawn from vial
    • Enter as Doses Wasted – Reason: Other
    • For example, if you are only able to draw five doses from Pfizer vial rather than six, enter one dose as wasted.
COVID-19 vaccine wastage that must be reported with a Wastage Form, and should not be reported in WIR:

The only instance in which Wastage Form, F-02328 needs to be filled out and wastage should not be reported in WIR, is when COVID-19 vaccine is expired per the expiration date on the vial.

Use the following steps to submit the Wastage Form for expired COVID-19 vaccine:

  1. Fill out the Wastage Form, F-02328 for the COVID-19 vaccine that has passed its expiration date (different from the BUD).
    • For Pfizer COVID-19 vaccine, the expiration date is printed on the label.
    • See the manufacturers’ websites for Moderna and Johnson & Johnson COVID-19 vaccines’ expiration dates.
  2. Email the Wastage form to the dhscovidvaccinator@dhs.wisconsin.gov and put “EXPIRED” in the subject line of the email.

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.

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.”

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 now need to leverage every opportunity to vaccinate to the fullest.

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.
  • Thaw fewer vials of vaccine when possible.
    • DHS regional managers are experiencing difficulties in supporting vaccinators who are requesting assistance in redistributing thawed vaccine that is about to expire. They will continue to try and support these efforts but will likely not be able to redistribute most requests at this time as supply far exceeds demand.
  • 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 scenarios that require a Redistribution Form 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/References

Vaccine redistribution, transportation, and transfers

Useful tools and resources for vaccine redistribution

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.

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.
    • If your organization does not have a Redistribution Form on file, generate and submit a Redistribution Form on the COVID-19 Vaccinator Enrollment Tool.
      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. Ensure that the Redistribution Form for your organization mirrors your organization’s Form A.
      4. Submit the Redistribution Form and await 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.
    • Utilize the Wisconsin COVID-19 Vaccine Exchange to share that you have COVID-19 vaccine to be redistributed. For more information, see the full announcement about the Wisconsin COVID-19 Vaccine Exchange.
    • 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.
  4. 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.
  5. Redistribute any unused COVID-19 vaccine.
  6. If additional support is needed, please contact dhscovidvaccinator@wi.gov.

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 now 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 Health Center Program Support or call 877-464-4772, option 2, 6:00 a.m. to 7:00 p.m. CT, Monday-Friday (except federal holidays). Additional information will be 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.

Ancillary kit deficiency reporting

As a reminder, vaccinators are encouraged to report any issues with equipment in the ancillary kits that are shipped with their federal vaccine orders. There are three steps to reporting to ensure enough information is gathered so problem trends in packaging and shipping can be identified.

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

Update your public profile on Vaccines.gov

Vaccines.gov helps people find clinics, pharmacies, and other locations that offer COVID-19 vaccines in the U.S.

Vaccinators are encouraged to create a Vaccines.gov (VaccineFinder) profile and keep their public-facing information current. Public-facing information includes their website, phone number, hours, whether site is displayed or not, and additional details.

As a reminder, vaccinators only need to provide public-facing information. DHS is currently reporting daily inventory data to Vaccines.gov and will continue to provide vaccine type, in-stock inventory data, and site address information on behalf of vaccinators. Please note, Vaccines.gov only displays whether or not vaccine is in-stock, it does not display inventory numbers.

If you have not yet created a profile:
  • You will need to be on boarded to VaccineFinder using the COVID Locating Health provider portal. You should have received an email from vaccinefinder@auth.castlighthealth.com on Monday, May 17, to begin the registration process. If you cannot locate this email, please email dhscovidvaccinator@wi.gov.
  • The initial registration email goes to the identified organization contact listed under Form A of the Provider Agreement to set up the reporting structure for the organization.
    • If the organization contact designates site level reporting, this triggers registration emails to be sent to the 2 site level vaccine coordinators listed in Form B of the Provider Agreement.
    • If the email address the registration email is sent to is incorrect, please email DHS at dhscovidvaccinator@wi.gov.
  • Once registered, you will be responsible for managing the public display information for your locations on vaccines.gov through the portal. To begin, check your public display details to make sure the information is accurate.
  • Providers have the option of uploading a spreadsheet or filling out a manual form to update their public display information. Guides for each option are below.
  • Please note, vaccinators will not be able to update their inventory settings or addresses. To make changes to inventory display or address please email dhscovidvaccinator@wi.gov with the subject "Vaccines.gov".
  • For more information about onboarding, see VaccineFinder's additional COVID-19 provider resources.
Best Practices:

DHS encourages vaccinators to consider the following when updating their public profile information:

  • For single-day or pop-up clinics, please provide information at least three days prior to ensure visibility on the map.
  • Enter walk-in availability for your location and review and update the ”Notes” section to ensure any information previously submitted aligns with your walk-in availability.
  • Additional reminders for the “Notes” section:
    • Include information about what accommodations are available for individuals with disabilities and how they can contact your organization in advance.
    • Include information about parking, entrances, and other access details.
    • Include information in Spanish and/or other languages spoken by individuals in your community when possible.
  • You can also add a Vaccines.gov widget to your own web page to help patients find vaccination locations.
Support:

The CDC and VaccineFinder offer a number of resources for providers. It is recommended that all providers start with the VaccineFinder Checklist for Providers found on the COVID-19 Vaccine Provider Information webpage

DHS will continue to provide Vaccines.gov support to vaccinators.

For support with inventory or address issues, please email dhscovidvaccinator@wi.gov with the subject "Vaccines.gov," and a DHS representative will respond within 1-3 business days.

For all other support, please use the Contact Us link on Vaccines.gov.

Secure disposal of vials and packaging to avoid COVID-19 vaccine scams

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

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.
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.

Physical security for COVID-19 vaccine “points of distribution” action guide

Two guides were developed to provide points of distribution managers and organizers with information regarding potential physical threats and corresponding risk mitigation solutions. These guides were emailed to vaccine providers on February 26, 2021 from widhs@public.govdelivery.com. Local and tribal health departments can also find these guides on the PCA portal.

 Trainings

Required COVID-19 vaccine trainings

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

General COVID-19 Vaccine Training Modules

Pfizer Training Modules

Moderna Training Modules

Janssen Training Modules

Recommended and supplemental trainings

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

 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-approved vaccine mandatory. However, the FDA website indicates that a person has the right to refuse an EUA product.

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

Q: What types of providers can vaccinate?

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. As COVID-19 vaccines are approved under an emergency use authorization (EUA), a fact sheet produced by CDC will be available and will contain similar information to a VIS. It is now available for both the Pfizer and Moderna vaccines.

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.

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

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

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

A: Yes, in order to redistribute vaccine, you must have an approved COVID-19 Vaccine Provider Agreement (Forms A and B) on file. Your Form A must match your Redistribution Form on file.

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

A: Yes, in order to expedite processing of your paperwork and ensure all paperwork is connected in the database, the Redistribution Form should have the same reference number as your 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 DHS at dhscovidvaccinator@dhs.wisconsin.gov.

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

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

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

A: DHS is unable to guarantee expedited processing of Redistribution Forms. Providers who anticipate that they may need to redistribute vaccine in the future are encouraged to proactively submit a Redistribution Form and post that vaccine to the Wisconsin COVID-19 Vaccine Exchange. If you have any questions, please contact dhscovidvaccinator@dhs.wisconsin.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.

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

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

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

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 training

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

Q: Who needs to do the WIR training?

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

Q: What does the WIR training entail?

A: WIR training includes the following topics:

  • Client look up and entry of doses, including mass vaccination module

  • Inventory management, including reporting daily inventory

  • Use of bar code scanner

  • Transferring doses

  • Reporting wasted doses

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

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

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

Q: How do I assign trainings to users?

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

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

Gear and Compatibility View Setting

Tools Compatibility View Settings

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

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

Change Compatibility Settings dhfswir and dhswir

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

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

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

  • IR Administrator

  • IR Inventory Control

  • IR Typical User

  • IR Mass Vaccination

  • IR MV + Inventory

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

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 VFC and COVID-19 Vaccination Program comparison table 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: September 15, 2021

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