MINNESOTA DEPARTMENT OF HEALTH

Interim COVID-19 Vaccine Provider Guide

INFORMATION TO PLAN FOR AND ADMINISTER COVID- 19 VACCINE

Updated 9 / 2 /2021

Information in this guide is current as of September 2, 2021. The COVID-19 vaccine response is changing quickly. Please make sure you have the most current version of this document, which can be found at COVID-19 Vaccine Providers (www.health.state.mn.us/diseases/coronavirus/vaccine/provider.html).

1 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE Table of Contents Interim COVID-19 Vaccine Provider Guide ...... 1

Background ...... 4

Use of this guide ...... 5

Training requirements ...... 5

COVID-19 vaccine ordering and distribution ...... 5

Actions your site can take to prepare ...... 6

Determining your COVID-19 vaccine order ...... 6

COVID-19 vaccine supplies ...... 7

COVID-19 vaccine products ...... 7

COVID-19 vaccine storage and handling ...... 8

Expiration date and beyond-use date (BUD) ...... 8

Managing out-of-range temperatures (excursions) ...... 9

Information to include when reporting a vaccine excursion ...... 9

Clinical considerations for authorized vaccines ...... 10

MDH-specific guidance on COVID-19 vaccine recommendations ...... 11

Resources for screening patients before COVID-19 vaccination ...... 11

COVID-19 vaccine administration ...... 11

Reconstituting vaccine ...... 11

Intramuscular administration...... 12

Vaccine administration resources ...... 13

Fainting (syncope) ...... 14

COVID-19 vaccine second doses ...... 15

Second dose reminders are critical ...... 15

Post-vaccination care ...... 16

2 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Vaccine efficacy ...... 16

Post-vaccination instructions ...... 16

Guidance on post-vaccination symptoms ...... 17

Treatment of post-vaccination symptoms ...... 17

Allergic reaction (anaphylaxis) ...... 17

Report vaccine adverse events and administration errors ...... 19

Document administered doses ...... 20

Public health recommendations for fully vaccinated people ...... 20

COVID-19 vaccine reporting requirements ...... 20

Data elements for COVID-19 vaccination reporting...... 21

Managing vaccine inventory ...... 22

Reporting vaccine inventory ...... 22

Reporting vaccine wastage and spoilage ...... 22

Security and disposal of vaccine vials ...... 23

Billing and reimbursement ...... 23

COVID-19 vaccine administration fee ...... 23

3 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Background

In March 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. Immunization with a safe and effective COVID-19 vaccine is critical to reduce COVID-19-related illnesses, hospitalizations, and deaths. The goal in the United States is to have enough COVID-19 vaccine for all people who wish to get vaccinated.

Initial vaccines were authorized by emergency use authorizations (EUA) from the Food and Drug Administration (FDA) when enough preliminary data on their effectiveness and safety was collected. In a global health pandemic, an EUA allows the FDA to review information from a vaccine manufacturer to determine if a vaccine can be released early. They weigh the benefits of early release against the known and unknown risks of a vaccine. Information about effectiveness and safety continues to be collected as we administer these vaccines during the public health emergency. If at any time vaccine data shows more risk than benefit, an EUA is re-evaluated.

On Aug. 23, 2021, the FDA granted the Pfizer-BioNTech COVID-19 vaccine full approval of their vaccine product. Pfizer-BioNTech COVID-19 vaccine (Comirnaty) is currently the only FDA-licensed vaccine for the prevention of COVID-19 disease in people 16 years and older. A fully licensed vaccine does not impact current FDA and Centers for Disease Control and Prevention (CDC) recommendations for use. Administration of the Pfizer vaccine to 12-15-year-olds and an additional dose for moderately to severely immunocompromised people are still covered under the current EUA. Refer to Appendix A for details regarding the Pfizer COVID-19 vaccine.

Providers are responsible for adhering to all requirements outlined in the CDC COVID-19 Vaccination Program Provider agreement. Specifically, providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of CDC, the Advisory Committee on Immunization Practices (ACIP), and FDA. This applies to both EUA and FDA approved COVID-19 vaccines. Accordingly, use of these products outside of those that have been approved and authorized by FDA (often referred to as “off-label use”) is not recommended. It would violate the provider agreement and could expose providers to the following risks:

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

4 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Use of this guide

Anyone who will handle and/or administer COVID-19 vaccine should read this guide and the accompanying appendices for the vaccine that they are receiving at their site. It is recommended to bookmark this guide for easy reference and check back often for updates. Updates to this guide and appendices are highlighted in the weekly COVID-19 vaccine provider bulletin. Sign up at COVID-19 Vaccine Updates (www.health.state.mn.us/diseases/coronavirus/vaccine/vaxbulletin.html). Training requirements

For registered COVID-19 vaccine providers, the vaccine coordinator and back-up coordinator at each site that are identified during the registration process are required to read this COVID-19 vaccine provider guide and watch MDH’s online COVID-19 Vaccination Providers Training 2021. Please have the guide available as you view the training. Even if you completed previous COVID-19 vaccination provider trainings, you will need to complete this training. The training will take approximately 30 minutes to complete, and you have the option to claim 0.5 CEUs. After completing the training, keep the certificate for your records. To complete the training, go to the MDH Learning Center (www.health.state.mn.us/about/tools/learningcenter.html) to create an account and enroll in the COVID-19 Vaccination Providers Training 2021. You can find the course in the catalog under “Infectious Disease.” Questions on the training can be directed to [email protected].

Roles and responsibilities . The vaccine coordinator, at every enrolled provider site, is responsible for making sure that staff handling and administering vaccine are properly trained on storage, handling, preparation, and administration of the vaccine as applicable to their role. . The coordinator can host an internal training and/or require all staff to complete the On-Demand Trainings for Registered COVID-19 Vaccine Providers (www.health.state.mn.us/diseases/coronavirus/vaccine/training.html#demand). . Staff new to vaccinating may need additional hands-on training.

Providers should track, maintain documentation, and monitor the training status of staff.

COVID-19 vaccine ordering and distribution

Registered COVID-19 providers should directly request COVID-19 vaccines in the Minnesota Immunization Information Connection (MIIC). Learn more on how to request special event vaccine in MIIC at MIIC User Guidance and Training Resources (www.health.state.mn.us/people/immunize/miic/train/index.html) under "Vaccine Ordering and Management." Before requesting COVID-19 vaccine, please read the considerations below.

5 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Actions your site can take to prepare . Determine who within your organization will request COVID-19 vaccine in MIIC. This may involve a conversation with your organization’s leadership. . Check with your vaccine ordering staff to identify if they have a MIIC user role with ordering privileges. Login to MIIC and view your user role at the top of the home page. If your role ends with the words “with ordering” then you will have access to place COVID-19 vaccine requests in MIIC. . If you do not have a user role “with ordering,” consult with your MIIC administrator to update your role. Typically, there is a MIIC user at each site who is designated as a MIIC administrator. This person oversees the MIIC accounts for the staff at their site. If you have an administrator role, you can create user roles for your staff. Refer to the Managing Users (www.health.state.mn.us/people/immunize/miic/train/admin.pdf) user guide. . If you do not have staff with that role, contact [email protected] for assistance. Determining your COVID-19 vaccine order

Order what your site will need for the week ahead. Include the total number of doses needed (first and second doses). MDH will no longer automatically ship second doses to sites.

COVID-19 vaccine requests need to be made in specific multiples of shipment packaging sizes:

. Janssen/Johnson & Johnson COVID-19 multi-dose vials of 5 doses: requests must be made in 100 dose increments. We cannot ship less than 100 doses. . Moderna COVID-19 multi-dose vials of 10 doses: requests must be made in 100 dose increments. We cannot ship less than 100 doses. . Moderna COVID-19 multi-dose vials of 14 doses: requests must be made in 140 dose increments. We cannot ship less than 140 doses. . Pfizer COVID-19 195 multi-dose vials of 6 doses: requests must be made in 1,170 dose increments. We cannot ship less than 1,170 doses.

You will receive an order confirmation email when your order is created and a vaccine shipment confirmation email once vaccine doses ship. MDH will automatically send these emails to the contacts provided for each location listed in section B of the provider agreement.

Enrolled and approved sites do not need to complete any additional registration with the vaccine manufacturer or distributor to receive doses.

COVID-19 vaccine providers do not need to be enrolled in the Minnesota Vaccines for Children program to vaccinate people ages 12 to 18 with COVID-19 vaccine.

6 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

COVID-19 vaccine supplies

COVID-19 vaccines and additional supplies are distributed at no cost to providers registered for COVID- 19 vaccination. Ancillary supply kits are automatically ordered in amounts to match vaccine orders. Each ancillary kit will contain these supplies:

. Needles (22-25 gauge, 1 to 1.5 inch, depending on the population being vaccinated). . Syringes (ranging from 1-3 milliliters). . Alcohol prep pads. . Surgical masks and face shields for vaccinators. . COVID-19 vaccination record cards for vaccine recipients. . CDC: Vaccine Administration: Needle Gauge and Length (www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf).

Pediatric ancillary kits will become available with the same supplies as adult kits, except they will include 1-inch needles only. For vaccines requiring reconstitution, diluent will be included, along with extra syringes, needles, and alcohol pads. The diluent will not come with the vaccine.

Note: Kits do not include sharps containers, gloves, or bandages.

For centrally-distributed vaccine(s), providers can opt out of getting ancillary and mixing kits. For vaccines shipped directly from the manufacturer (e.g., Pfizer), a combined kit will be included that contains administration supplies (as noted above), mixing supplies, and diluent vials. If you redistribute vaccine, you also need to redistribute the ancillary supplies.

For questions or problems related to ancillary supply kits (e.g., missing supplies, etc.), contact:

. Pfizer vaccine: McKesson MedSurg to report by email [email protected]. . Moderna/Janssen vaccine: McKesson Specialty at 833-343-2703 or by email [email protected].

For defective or faulty medical equipment (e.g., syringes, needles), go to FDA’s MedWatch Online Voluntary Reporting Form (www.accessdata.fda.gov/scripts/medwatch/) and complete form 3500.

COVID-19 vaccine products

Vaccine products vary based on dosage, number of doses needed, intervals between doses, and how the vaccine must be stored and handled. Several COVID-19 vaccines are currently available and more may become available as vaccine trials are completed. This makes COVID-19 vaccine more accessible, but it may also increase the risk of medication errors. Doublecheck the product-specific emergency use authorization provider fact sheet or package insert for age indication, route, dosage, and storage and handling requirements.

7 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Any COVID-19 vaccine can be used when indicated; there is no product preference. However, COVID-19 vaccines are not interchangeable.

Refer to the correct appendix section in this guide for the COVID-19 vaccine(s) that you will be administering for detailed vaccine product information about shipping, storage, redistribution, vaccine recommendations, contraindications/precautions, side effects, and vaccine preparation.

Age Dose Vaccine Schedule Appendix group Route

Pfizer- ≥ 12 0.3 mL Appendix A: Pfizer-BioNTech COVID-19 Vaccine Days 0, 21 BioNTech years IM (www.health.state.mn.us/diseases/coronavirus/vaccine/guideappa.pdf)

≥ 18 0.5 mL Appendix B: Moderna COVID-19 Vaccine Moderna Days 0, 28 years IM (www.health.state.mn.us/diseases/coronavirus/vaccine/guideappb.pdf)

Janssen ≥ 18 0.5 mL Appendix C: Janssen COVID-19 Vaccine (Johnson & years IM Single dose (www.health.state.mn.us/diseases/coronavirus/guideappc.pdf) Johnson)

COVID-19 vaccine storage and handling

COVID-19 vaccine products are temperature-sensitive and must be stored and handled correctly to ensure efficacy and maximize shelf life. Proper storage and handling practices are critical to minimize vaccine loss and limit risk of administering COVID-19 vaccine with reduced effectiveness.

Cold-chain storage and handling requirements for COVID-19 vaccine products vary. Follow specific shipping, storage, and handling requirements for each vaccine product in their respective appendices.

Vaccine must be stored in dedicated vaccine units. Find more information on CDC’s storage and handling recommendations at Vaccine Storage and Handling Toolkit (www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html). Storing vaccine in the freezer of a combination household unit is not recommended. If your facility provides frozen vaccine, you must have a separate freezer.

. Refer to Appendix D: Vaccination at Satellite, Temporary, or Off-site Locations (www.health.state.mn.us/diseases/coronavirus/vaccine/guideappd.pdf) for storage and handling guidance. This appendix has many helpful resources for transporting vaccine and monitoring temperatures.

If you are new to vaccine storage and handling, you may want to view CDC’s, You Call the Shots module. Learn more at CDC: CE Instructions for WB4266: Immunization: You Call the Shots-Module Ten-Storage and Handling—2020 (www2a.cdc.gov/nip/isd/ycts/mod1/courses/sh/ce.asp). Expiration date and beyond-use date (BUD)

All vaccines have expiration dates. Sometimes vaccines must be used before the expiration date. This is referred to as the beyond-use date (BUD). For COVID-19 vaccines, the BUD is determined based on the

8 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE date a vial is first entered (punctured) and the storage information in the EUA fact sheet (or package insert). With COVID-19 vaccines, the BUD date will change if the vaccine is modified or stored in a certain way. The person who makes a change to the vaccine (e.g., punctures the vial, reconstitutes it, moves it from the freezer to refrigerator, etc.) must document the BUD on a label. BUD tracker labels are available on CDC’s website.

Check expiration dates and beyond-use dates closely. Discard the vaccine based on the earliest date, whether that is the manufacturer’s labeled expiration date or the BUD.

Example: Undiluted Pfizer vaccine can be stored for one month in the refrigerator. If it was placed in the refrigerator on June 22, its BUD is July 22. However, if the vaccine vial’s expiration date is July 8, then it needs to be discarded at the end of the day on July 8.

Keep in mind that COVID-19 vaccine products do not contain any preservative and expire hours after the vial is first punctured. Carefully read and follow the EUA fact sheet for health care providers and/or manufacturers’ websites for each vaccine product regarding expiration and beyond-use dates.

Managing out-of-range temperatures (excursions)

As with all vaccines, if COVID-19 vaccines are exposed to out-of-range temperatures, take immediate action. Mark the vaccine “do not use” until its usability is determined. If vaccine thaws, do not re-freeze.

. Contact MDH’s Immunization Program between 8 a.m. and 4:30 p.m. at 651-201-5414 to determine your next steps. Make sure to have specific information about temperatures, duration of excursion, etc. available. . When MDH is not available (e.g., closed on weekends, evenings, and holidays), CDC is taking COVID- 19 vaccine calls 24 hours a day/seven days a week (including holidays) at 800-CDC-INFO (800-232- 4636). Some vaccine manufacturers are available 24 hours a day, 7 days a week. . Some vaccine manufacturers have online temperature excursion tools you may use. Continue to call MDH (or CDC after hours) if you have an out-of-range temperature. Information to include when reporting a vaccine excursion . Your email address and phone number. . Storage condition at the time of excursion (e.g., frozen storage, refrigerated storage, or room temperature). . Duration of excursion. . Interim disposition of affected vials (e.g., returned to freezer or refrigerator, moved to another storage unit, or maintained at room temperature). . Visual inspection, noting any change in the vaccine’s state (e.g., frozen vials that thawed or thawed vials that were re-frozen).

9 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

If the vaccine is determined to be nonviable (not usable) it should be discarded immediately. These doses should be reported as nonviable vaccine to MDH in the Minnesota Immunization Information Connection (MIIC). Refer to the section on reporting vaccine wastage and spoilage for instructions.

Clinical considerations for authorized vaccines

ACIP has issued interim recommendations for the use of COVID-19 vaccines for the prevention of COVID-19. These recommendations are published in CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States (www.cdc.gov/vaccines/covid-19/info-by- product/clinical-considerations.html).

CDC is updating these recommendations frequently as new vaccines are authorized and information changes. A summary of recent changes and the date they were last updated is at the top of the webpage. Use the “On This Page” links in the right sidebar to take you to the different sections:

. Background . Age groups approved or authorized to receive COVID-19 vaccine by vaccine product . Vaccine administration . Interchangeability of COVID-19 vaccine products . People vaccinated for COVID-19 outside the United States . People vaccinated for COVID-19 as part of a clinical trial in the United States . Coadministration with other vaccines . COVID-19 vaccination and SARS-CoV-2 infection . Antiviral therapy and COVID-19 vaccination . Vaccinating people with a known COVID-19 exposure or during COVID-19 outbreaks . Considerations for use of an additional dose of COVID-19 vaccine following a primary vaccine series . Considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose COVID- 19 mRNA vaccine series for immunocompromised people . Considerations for vaccination of people with certain underlying medical conditions . Considerations for the use of the Janssen vaccine in certain populations . Considerations involving pregnancy, lactation, and fertility . Vaccination of children and adolescents . Patient counseling . Contraindications and precautions . Reporting of vaccine adverse events . Laboratory testing

10 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

. Appendix A. Vaccine administration errors and deviations . Appendix B: Triage of people presenting for COVID-19 vaccination . Appendix C: Ingredients included in COVID-19 vaccines . Appendix D: Potential characteristics of allergic reactions, vasovagal reactions, and vaccine side effects following COVID-19 vaccination MDH-specific guidance on COVID-19 vaccine recommendations

Use of immune-based tests for tuberculosis (TB) infection: COVID-19 vaccines should not be delayed because of testing for TB infection, such as a tuberculin skin test (TST) or interferon gamma release assay (IGRA) blood test. Find additional information regarding laboratory testing in CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States (www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html). Resources for screening patients before COVID-19 vaccination . MDH COVID-19 Vaccine Screening and Agreement template on COVID-19 Vaccine Providers (www.health.state.mn.us/diseases/coronavirus/vaccine/provider.html). . CDC: Prevaccination Checklist for COVID-19 Vaccines (www.cdc.gov/vaccines/covid- 19/downloads/pre-vaccination-screening-form.pdf).

COVID-19 vaccine administration

Based on their scope of practice, all people who administer vaccines should receive comprehensive, competency-based staff training and education, including the “rights of vaccine administration”; patient care before, during, and after vaccine administration; vaccine preparation; and skill validation.

Always use one needle, one syringe, only one time.

Learn more about safe injection practices at One & Only Campaign (www.cdc.gov/injectionsafety/one- and-only.html). Reconstituting vaccine

Follow the specific instructions provided in the product information for vaccine that requires reconstitution (or dilution). Vaccines should be reconstituted using only the specific diluent required by the manufacturer for that vaccine.

. Pfizer-BioNTech vaccine requires dilution with sterile 0.9% Sodium Chloride Injection, USP. If an incorrect diluent type is used (e.g., sterile water, bacteriostatic 0.9% normal saline), contact the manufacturer for guidance and if they support repeating the dose, it may be given immediately (no minimum interval) in the opposite arm.

11 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Changing the needle between drawing vaccine from the vial and administering the vaccine is not necessary, unless the needle is contaminated or damaged, or the needle gauge is too large for vaccine administration (e.g., a 21-gauge needle used to reconstitute vaccine). Intramuscular administration

Always adhere to strict aseptic practices while preparing and giving injectable vaccines. Use good hand hygiene by cleaning with an alcohol-based waterless antiseptic hand rub or washing with soap and water before preparing vaccines for administration and between each patient contact.

Wear the appropriate personal protective equipment (PPE) when administering COVID-19 vaccine. It is recommended to wear a medical facemask (i.e., surgical or procedural mask). Do not wear a cloth mask.

Other recommended personal protective equipment includes eye protection (e.g., goggles or a face shield that covers the front and side of the face) in areas with moderate to substantial community transmission. Gloves are optional. CDC has a pictorial representation of personal protective equipment requirements in Vaccine Administration: COVID-19 Personal Protective Equipment (www.cdc.gov/vaccines/hcp/admin/downloads/COVID-19-vaccine-administration-PPE-508.pdf).

Follow the “seven rights” of vaccine administration: right patient; right vaccine/diluent; right time; right dose; right route; right site; right documentation.Choosing the correct anatomic site and appropriate needle length for intramuscular (IM) injections depends on age and body mass. For all intramuscular injections, the needle should be long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue, but not so long as to involve underlying nerves, blood vessels, or bone.

Needle size and site of injection must be decided for each person based on the size of the muscle and the thickness of adipose tissue around the muscle. This is usually a 1 to 1.5-inch needle for adults and 1 inch for adolescents. Refer to MDH’s How to Administer IM (Intramuscular) Injections (www.health.state.mn.us/people/immunize/hcp/admim.pdf).

Avoid shoulder injury related to vaccine administration (SIRVA) in adults by administering the vaccine correctly in the deltoid muscle. Giving the intramuscular injection too close to the shoulder joint can cause bursitis, fasciitis, and other injury. Report shoulder injury related to vaccine administration to the Vaccine Adverse Event Reporting System (VAERS).

To administer a deltoid injection, place three fingers from the top of the shoulder (acromion). Have the patient lift their arm (you should be able to see and feel the deltoid muscle contract). Once you have located the middle of the muscle, have the patient relax their arm and give the injection at a 90-degree angle to the middle muscle point.

12 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

When injecting the vaccine into the patient, follow these steps:

. Clean the area to be injected in a circular motion using a sterile alcohol wipe, starting in the center and working outward. . Insert the needle smoothly and quickly at a 90-degree angle (for intramuscular). . Hold the syringe steady once the needle is in the tissue; moving it around the tissue may cause damage. . Inject the vaccine – slowly, but smoothly. . Withdraw the needle smoothly at the same angle it was inserted. . Apply gentle pressure to the site with either an alcohol pad or a sterile gauze pad. . Apply a bandage at the site if bleeding occurs1. Vaccine administration resources

Vaccine administration resources for all people who vaccinate, including staff who are new to vaccination and staff who need a refresher:

. CDC: Immunization Education and Training (www.cdc.gov/vaccines/ed/index.html) . CDC: COVID-19 Vaccination Training Programs and Reference Materials (www.cdc.gov/vaccines/covid-19/downloads/COVID-19-Clinical-Training-and-Resources-for- HCPs.pdf) . CDC: You Call the Shots (www.cdc.gov/vaccines/ed/youcalltheshots.html) Watch the “Vaccine Administration” e-Learn . CDC: Epidemiology and Prevention of Vaccine-Preventable Diseases (www.cdc.gov/vaccines/pubs/pinkbook/index.html) Known as the “Pink Book” . Intramuscular (IM) Injection: Sites (https://youtu.be/PqSuCPnPeYE) . Preparing COVID-19 Vaccines for Administration (www.health.state.mn.us/diseases/coronavirus/vaccine/provider.html) . COVID-19 Vaccine Trainings for Health Professionals (www.health.state.mn.us/diseases/coronavirus/vaccine/training.html#supp) MDH: Immunization Basic Principles supplemental on-demand training for vaccine providers . CDC: Pediatric Healthcare Professionals COVID-19 Vaccination Toolkit (www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits/pediatrician.html) . CDC COVID-19 Vaccine Administration Errors and Deviations (www.cdc.gov/vaccines/covid- 19/downloads/covid19-vaccine-errors-deviations.pdf) EUA fact sheets and vaccine information sheets (VISs)

1 Perry, Potter, & Ostendorf (2018). Clinical Nursing Skills & Techniques, (9th Ed), pp. 576-577. St. Louis, MO: Elsevier.

13 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

The FDA commissioner may authorize the use of vaccine during a public health emergency to protect the nation’s health. The type of information sheet provided to a person being vaccinated depends on whether the vaccine received an FDA emergency use authorization (EUA) or was licensed by the FDA. Fainting (syncope)

Patients, especially adolescents, are at risk for falls due to syncope during and after vaccine administration, which can result in serious injury. To decrease this risk, have a place for patients to sit down while they are vaccinated and be ready to lower them to a laying position, if needed. Know the signs someone has before fainting: pale complexion, weak, dizzy, and/or sweating.

Emergency use authorization fact sheets

Emergency use authorization fact sheets for vaccination providers are product-specific information sheets that replace the usual package insert. A separate fact sheet for vaccine recipients is similar to a licensed product’s vaccine information sheet.

The emergency use authorization fact sheet for vaccine recipients explains the vaccine risks and benefits, specific vaccine product information and its use, and information from clinical trials that support the FDA’s emergency use authorization.

. You are legally required to give an emergency use authorization fact sheet to each recipient/parent/legal representative prior to vaccination. Be prepared to answer questions about the vaccine.

Emergency use authorization fact sheets for providers and recipients are available on FDA, CDC, MDH, and vaccine manufacturer websites. Translated fact sheets in multiple languages are on the FDA website:

. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine (www.fda.gov/emergency-preparedness-and- response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine) . Moderna COVID-19 Vaccine (www.fda.gov/emergency-preparedness-and-response/coronavirus- disease-2019-covid-19/moderna-covid-19-vaccine) . Janssen COVID-19 Vaccine (www.fda.gov/emergency-preparedness-and-response/coronavirus- disease-2019-covid-19/janssen-covid-19-vaccine)

Vaccine information sheets (VIS)

Vaccines licensed through the FDA and added to the vaccine injury table are required to have a vaccine information sheet. Federal law requires that patients receive a vaccine information sheet prior to administration of a licensed vaccine.

14 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

COVID-19 vaccine second doses

For COVID-19 vaccines that need two doses, it is important that people receive both doses, and that both doses are the same vaccine product. Make every effort to keep the second doses within the recommended interval. If the interval is missed, the second dose should be given as soon as possible. The series does not need to be restarted. For additional information about prioritizing second doses, visit COVID-19 Vaccine Second Dose Guidance (www.health.state.mn.us/diseases/coronavirus/vaccine/seconddose.html).

For COVID-19 vaccine products that require two doses, providers need to understand the interval between each dose for the vaccine product being used.

. Make sure each person getting vaccinated knows how long they must wait between their first and second vaccination. . Different COVID-19 vaccine products are not interchangeable. Use the same product for both the first and second doses.

Note: The Janssen vaccine does not require two doses. Second dose reminders are critical

Second dose reminders are critical to ensure compliance with vaccine dosing intervals and to achieve optimal vaccine effectiveness.

Ideas to help ensure someone gets their second dose

Make every attempt to schedule a person’s second dose appointment when they get their first dose, or schedule both appointments when scheduling the first appointment.

Complete a COVID-19 vaccination record card (vaccine manufacturer, lot number, date of first dose, and the date that the second dose due) for each person who is vaccinated. Encourage them to keep the card, so they can check to make sure their second dose comes from the same manufacturer as their first dose.

. If the patient has a smartphone, ask them to take a photo of their vaccination card and/or enter the date when the next vaccine is due into their electronic calendar.

Encourage people to enroll in V-safe After Vaccination Health Checker (www.cdc.gov/coronavirus/2019- ncov/vaccines/safety/vsafe.html) and VaxTextSM COVID-19 Vaccination Second-Dose Reminder (www.cdc.gov/vaccines/covid-19/reporting/vaxtext/index.html), which use free text messaging to receive COVID-19 vaccine second dose reminders.

15 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Minnesota Immunization Information Connection (MIIC):

. Record all vaccinations in MIIC within 24 hours after vaccine administration. . Pull lists of people that need to complete the COVID-19 vaccine series using the MIIC client follow- up functionality in MIIC. Information on client follow-up for COVID-19 vaccine will be available on MIIC User Guidance and Training Resources (www.health.state.mn.us/people/immunize/miic/train/index.html).

Look at your emergency health record or vaccine management tool to identify if there is a second dose reminder function already built in (e.g., patient portal).

Use other methods, such as text messaging, phone calls, email, and mail.

Post-vaccination care Vaccine efficacy

For mRNA COVID-19 vaccines (Pfizer BioNTech and Moderna), preliminary data suggest they are highly effective in preventing COVID-19 after completing the two-dose series.

Preliminary data suggest viral vector COVID-19 vaccine (Janssen) has an overall effectiveness against symptomatic, laboratory-confirmed COVID-19 at least 14 days after vaccination. In clinical trials, this vaccine was highly effective in preventing COVID-19-associated hospitalization at least 28 days after vaccination. Post-vaccination instructions

Preparing people for what to expect after vaccination and when to follow up with a health care provider is a best practice for vaccination and can ease a person’s anxiety. Patient instructions should include information specific to the product they are receiving. This information should include:

. Common side effects (listed in the emergency use authorization fact sheet). . When to contact their health care provider (such as signs of an allergic reaction or medical concerns that may or may not be related to vaccination). . For vaccine(s) requiring two doses, the importance of receiving the second dose of vaccine to build an adequate immune response. . When they are considered fully vaccinated (two weeks after their final dose) and what that may mean for them (refer to the Public health recommendations for fully vaccinated people section below). . The v-safe fact sheet and poster, found at CDC: V-safe Print Resources (www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe/printresources.html). V-safe is a CDC reporting tool that uses smartphones for active monitoring for COVID-19 vaccine safety and is available in multiple languages. V-safe:

16 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

▪ Uses text messaging and web surveys to check in with vaccinated people at scheduled intervals: daily for one week; weekly for up to five weeks; and then at three, six, and twelve months after the second dose. ▪ Allows participants to report side effects and health impacts following COVID-19 vaccination. ▪ Parents and guardians are encouraged to enroll their child. They can complete health surveys on behalf of their adolescents, describing symptoms and health events after vaccination. ▪ Includes live phone follow-up through the Vaccine Adverse Event Reporting System, with people reporting a clinically significant event (e.g., missed work, unable to perform normal daily activities, seeking medical care) during any v-safe health check. ▪ Provides second dose reminders (if needed). ▪ Learn more at V-safe After Vaccination Health Checker (www.cdc.gov/coronavirus/2019- ncov/vaccines/safety/vsafe.html). Guidance on post-vaccination symptoms

CDC has resources on post vaccination considerations for health care workers and residents of long- term care facilities to help determine if post-vaccination symptoms are vaccine-related or COVID-19- related:

. Post-vaccination Considerations for Workplaces (www.cdc.gov/coronavirus/2019- ncov/community/workplaces-businesses/vaccination-considerations-for-workplaces.html) . Post Vaccine Considerations for Residents (www.cdc.gov/coronavirus/2019-ncov/hcp/post-vaccine- considerations-residents.html) Treatment of post-vaccination symptoms

After receiving a COVID-19 vaccine dose, over-the-counter fever or pain medication (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be used for local or systemic symptoms, if medically appropriate. Refer to the applicable appendix to view side effects listed for each vaccine product.

It is not recommended to routinely take over-the-counter fever or pain medication to prevent symptoms following vaccination. The impact of using the medications’ for COVID-19 vaccine-induced antibody responses is not available at this time. Allergic reaction (anaphylaxis)

Anaphylactic reactions in people receiving the COVID-19 vaccine outside of clinical trials have been reported. While rare, these events highlight the importance of a quick and competent response. Refer to CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States: Contraindications and precautions (www.cdc.gov/vaccines/covid-19/info-by-product/clinical- considerations.html#Contraindications) for more information regarding adverse reactions.

17 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Appropriate medical treatment used to manage immediate allergic reactions (e.g., epinephrine) must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

An allergic reaction to a vaccine is a life-threatening event. Know the early signs of anaphylaxis: throat closing sensation; swelling of throat, face or lips; hives; itching; stridor (high-pitched whistling sound); wheezing; coughing; dizziness; fainting; fast heart rate; low blood pressure; nausea; vomiting; diarrhea; and/or abdominal pain. CDC has a helpful poster on Recognizing and Responding to Anaphylaxis (www.cdc.gov/vaccines/covid-19/downloads/recognizing-responding-to-anaphylaxis-508.pdf).

Observation periods following vaccination

Observation periods pertain to every dose of vaccine given, including additional doses.

For 30 minutes:

. People with a history of immediate allergic reaction of any severity to a vaccine or injectable therapy. . People with a contraindication to a different type of COVID-19 vaccine (e.g., people with a contraindication to mRNA COVID-19 vaccines who received Janssen viral vector vaccine). . People with a history of anaphylaxis (due to any cause).

For 15 minutes: All other people.

Emergency preparation

Administer vaccines in settings where staff are trained to recognize and respond to reactions. Immediate systemic reactions can include fainting (syncope) and severe allergic reaction (anaphylaxis). Learn more about how to prepare for anaphylactic reactions at CDC’s Interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccination (www.cdc.gov/vaccines/covid- 19/info-by-product/pfizer/anaphylaxis-management.html).

Some considerations:

. Staff should be trained in CPR and be familiar with the signs, symptoms, and treatment of anaphylaxis. . Have the appropriate equipment and medication on hand. Have trained staff available to administer epinephrine and maintain an airway in settings where vaccinations are given. ▪ COVID-19 vaccination locations should have at least three doses of epinephrine available at all times and a way to quickly replace doses. . Have a signed hard copy of a plan and protocol for the medical management of a vaccine reaction. Ensure staff review the plan and protocol and are ready to carry it out before giving vaccinations or providing related services.

18 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

▪ The Immunization Action Coalition has examples of emergency plans. Refer to Medical Management of Vaccine Reactions in Children and Teens (www.immunize.org/catg.d/p3082a.pdf) and Medical Management of Vaccine Reactions in Adults (www.immunize.org/catg.d/p3082.pdf) for more information. Report vaccine adverse events and administration errors

As with licensed vaccines, vaccines under an Emergency Use Authorization have the same requirements to report to the Vaccine Adverse Event Report System (VAERS) any situations, including serious adverse events, that occurred after vaccination. This is regardless of determination of cause. As part of the CDC COVID-19 Vaccination Program Provider Agreement, vaccination providers are required to report the following to VAERS:

. Vaccine administration errors, even if they did not involve an adverse effect. . Death. . A life-threatening event. . An event requiring hospitalization or prolonged hospitalization. . Prolonged impact on a person’s ability to perform daily activities. . A congenital anomaly/birth defect. . A significant medical event. . Cases of Multisystem Inflammatory Syndrome (MIS) in children or adults. . Cases of COVID-19 that result in hospitalization or death.

Learn more about VAERS at CDC: 10 Things Healthcare Providers Need to Know about the Vaccine Adverse Event Reporting System (VAERS) (www.cdc.gov/coronavirus/2019- ncov/downloads/vaccines/10-things-healthcare-providers-need-to-know-about-VAERS.pdf). To submit an event, go to VAERS: Report an Adverse Event (vaers.hhs.gov/reportevent.html). There is a checklist on this page to help gather information needed when submitting a report (VAERS 2.0 Checklist [vaers.hhs.gov/docs/VAERS 2.0_Checklist.pdf]).

HIPAA permits reporting of vaccine adverse events and medical documentation to VAERS for public health purposes under 45 CFR, section 164.512(b), as authorized by 42 USC 300aa-25.

Resources to assist clinicians in possible COVID-19 vaccine-related adverse events

Urgent consults: Health care providers can contact the CDC Emergency Operations Center at 770-488- 7100 if they need an urgent COVID-19 vaccine safety consultation. In case of a health emergency, providers should call 911.

Complex health situations following COVID-19 vaccination: For complex vaccine safety questions, health care providers or health departments in the United States can request a consultation from the CDC: Clinical Immunization Safety Assessment (CISA) Project

19 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

(www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html) COVIDvax clinicians. For non- urgent concerns, providers may Contact CDC-INFO (wwwn.cdc.gov/DCS/ContactUs/Form). Document administered doses

Give the vaccinated person (and caregiver, if applicable), a completed COVID-19 vaccination record card that includes the name of the vaccine given, the date administered, and the name and location of the administering clinic. Providers should follow their usual documentation processes in the patient’s permanent medical record. Record vaccine administration information such as:

. Vaccine name. . Date of administration. . Vaccine manufacturer and lot number. . Vaccination site and route. . Name and title of the person who administered the vaccine. Public health recommendations for fully vaccinated people

We are still learning how vaccines will affect the spread of COVID-19. So, it is important for fully vaccinated people to continue to follow current public health guidance when recommended to protect themselves and others.

Review CDC’s Interim Public Health Recommendations for Fully Vaccinated People (www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html) for detailed information.

For health care workers, refer to COVID-19 Recommendations for Health Care Workers (www.health.state.mn.us/diseases/coronavirus/hcp/hcwrecs.pdf) and CDC: Updated Healthcare Infection Prevention and Control Recommendations in Response to COVID-19 Vaccination (www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html).

COVID-19 vaccine reporting requirements

The Minnesota Immunization Information Connection (MIIC) (www.health.state.mn.us/miic) stores electronic vaccination records that combine vaccinations individuals received at different locations across the state.

Per the CDC provider agreement, product-specific COVID-19 vaccination data must be reported within 24 hours of vaccine administration. Data reported to MIIC in a timely manner will be routinely sent to the CDC in de-identified form to meet their data requirements and in a manner consistent with Minnesota laws. There are a number of data elements for each COVID-19 vaccination that is administered.

20 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Data elements for COVID-19 vaccination reporting

These data elements are subject to change.

Vaccine recipient data . First name . Middle name . Last name . Date of birth . Sex . Full address (street, street 2, city, county, state, ZIP code) . Race/ethnicity*

*MDH requires providers to enter available race/ethnicity information into MIIC as part of their regular reporting for all patients who are getting vaccinated.

Vaccine administration data . Administration date . CVX code . NDC (if known) . MVX code . Lot number . Expiration date . Body site . Route of administration . Responsible organization . Administered at location . Vaccination refusal (when appropriate)

Become familiar with MIIC. If your organization already submits data to MIIC via:

. Electronic data exchange: Review your messages to ensure you are sending timely messages and that those messages contain a CVX/CPT code pair or an NDC code. Verify that your organization has a process to routinely review rejection (ACK) messages. . Upload the file via the user interface: Ensure you are submitting a CVX/CPT code pair. A new spreadsheet template is available in MIIC and the latest user guide can be found at General Immunization Upload Using the Spreadsheet Template (www.health.state.mn.us/people/immunize/miic/data/spreadsheet.pdf). Please download the

21 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

template from MIIC each time you use it. Consider creating an electronic interface with MIIC to reduce staff burden and help ensure timely data reporting. . Direct data entry: Ensure staff are selecting the correct option from the “Trade Name” drop-down menu. Strongly consider using one of the above reporting methods. Connecting to MIIC for electronic data exchange can reduce staff burden, especially during high-volume times.

Minnesota Statutes, chapter 144.3351 authorizes vaccine providers to share the required data elements with MDH, through MIIC, including race and ethnicity. Find Vaccine Administration Codes from CDC at Data Code Sets (www.cdc.gov/vaccines/programs/iis/code-sets.html).

Managing vaccine inventory Reporting vaccine inventory

MDH reports inventory to CDC daily. To facilitate this reporting and to give visibility to inventory across the state, all COVID-19 vaccine that is redistributed needs to be reported to MDH within 24 hours of redistribution. Learn more about COVID-19 vaccine redistribution at COVID-19 Vaccine: Redistribution and Off-site Vaccination Guide (www.health.state.mn.us/diseases/coronavirus/vaccine/vaxredistribution.pdf). Reporting vaccine wastage and spoilage

Tracking vaccine wastage is part of vaccine inventory. Sites are asked to report wastage or spoilage of vaccine doses (e.g., exposure to out-of-range temperatures, vaccines in refrigerator past the allowed time, doses drawn up and not used, doses remaining in vials at the time of the beyond use date (BUD) expiration, vaccine discoloration or particulates, unable to get the recommended number of doses out of a vial, etc.). Any vaccine determined to be nonviable (not usable) should be discarded immediately.

Registered COVID-19 providers should report vaccine wastage in MIIC. There are two ways to report wastage/spoilage. Choose one method of reporting:

. Preferred: Submit this information in MIIC. More information is available at Reporting Nonviable COVID-19 Vaccine to MIIC (www.health.state.mn.us/diseases/coronavirus/vaccine/nonviablereport.pdf). . If your organization is not able to use the preferred method of reporting via MIIC, you may use the PDF form, Minnesota Department of Health COVID-19 Nonviable Vaccine Form (www.health.state.mn.us/diseases/coronavirus/vaccine/nonviableform.pdf).

To report wasted vaccine to MIIC, you need to be set up with a MIIC user role that has ordering privileges. Please contact [email protected] with questions about getting set up to access this feature in MIIC.

Expired or spoiled COVID-19 vials are not being returned to the manufacturer or McKesson. When entering nonviable COVID-19 vaccine into MIIC, you may receive an email about returning vaccine. Please disregard the email. Returning vaccine is our process only for other, non-COVID-19 vaccines.

22 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

Security and disposal of vaccine vials

It is no longer recommended to dispose of COVID-19 vaccine and vials as normal solid waste. Due to the increased threat of fake or counterfeit vaccines, CDC convened an interagency working group of medical professionals, suppliers, and law enforcement. The working group recommends vaccination sites take appropriate steps to properly dispose of empty and wasted vaccine vials and product packaging. The following recommended actions will protect empty and wasted COVID-19 vaccine vials and packaging from counterfeit efforts:

. Action 1 (preferred method): Treat vials and packaging similarly to medical waste by placing in red sharps container; or . Action 2: Deface all, or safely crush, materials so they cannot be reintroduced or reproduced. After the products are sufficiently defaced, dispose with regular waste.

Vaccines are only available and administered through state-authorized vaccination locations. Non- medical companies or private people are not authorized to provide, sell, or administer vaccines. Any offers related to the sale or use of COVID-19 vaccines, not from a medical provider, should be considered suspicious and reported to the appropriate state or jurisdiction. This may include: State or local department of health, the U.S. Department of Health and Human Services, the Office of the Inspector General (www.oig.hhs.gov/) online or at 1-800-HHS-TIPS, or Submit a Tip (www.fbi.gov/tips) to the Federal Bureau of Investigation.

Requirements vary for other vaccines and pharmaceutical wastes. For more information, contact the Minnesota Pollution Control Agency (www.pca.state.mn.us) at 651-296-6300 or 800-657-3864 or email at [email protected].

Billing and reimbursement COVID-19 vaccine administration fee . There is no cost for COVID-19 vaccine for vaccine providers or for vaccine recipients. Per the CDC provider agreement, vaccine providers must administer COVID-19 vaccine, regardless of the vaccine recipient’s ability to pay COVID-19 vaccine administration fees or their insurance coverage status. There should be no out-of-pocket costs for COVID-19 vaccine. . Insurance plans should reimburse providers for the administration fee. Vaccine providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient. . For patients who have a Minnesota Health Care Plan (MHCP), providers will be reimbursed. As a reminder, vaccines are exempt from cost-sharing. Please contact the MHCP Provider Call Center at 651-431-2700 with any related questions. . For uninsured patients, the vaccine provider can seek reimbursement for an administration fee from the Health Resources and Services Administration Provider Relief (HRSA) Fund at COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured (www.hrsa.gov/coviduninsuredclaim).

23 of 24 INTERIM COVID- 19 VACCINE PROVIDER GUIDE

For more information regarding COVID-19 billing, refer to the Centers for Medicare & Medicaid Services: COVID-19 (www.cms.gov/covidvax-provider).

Providers may not seek any reimbursement directly from the patient, including through balance billing. Find vaccine administration codes from CDC at Data Code Sets (www.cdc.gov/vaccines/programs/iis/code-sets.html).

The Minnesota Department of Health wants to thank all health care workers who have worked tirelessly during this pandemic. Thank you for your dedication and efforts in working to overcome the devastating effects of COVID-19.

Minnesota Department of Health | health.mn.gov | 651-201-5000 625 Robert Street North PO Box 64975, St. Paul, MN 55164-0975 Contact [email protected] to request an alternate format.

24 of 24