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).