THE PFIZER-BIONTECH COVID-19 VACCINE RESOURCE GUIDE Your guide to utilizing the

THE PFIZER-BIONTECH COVID-19 VACCINE RESOURCE GUIDE Your guide to utilizing the Pfizer-BioNTech COVID-19 Vaccine resources The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com. Current as of June 25, 2021. For the most up-to-date information, visit www.cvdvaccine-us.com. 3 ABOUT THIS RESOURCE GUIDE This guide contains resources designed to assist you and your vaccination site in handling and administering the Pfizer-BioNTech COVID-19 Vaccine. Learn about each resource and how it can help ensure the vaccine is handled and administered correctly, according to the dosing schedule. These resources are also available at www.cvdvaccine-us.com. 5 4 IMPORTANT SAFETY INFORMATION •  Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine •  Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine  Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/ clinical-considerations/managing-anaphylaxis.html) •  Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances •  Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting •  Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients •  In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) •  In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) •  Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials: •  severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) •  myocarditis and pericarditis  Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine •  Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy •  Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion •  There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series •  Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report •  Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization •  Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com TABLE OF CONTENTS EMERGENCY USE AUTHORIZATION (EUA) FACT SHEETS.....................................6 -  Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) - Fact Sheet for Recipients and Caregivers PREPARE TO RECEIVE THE VACCINE...................................................................7 - Checklist for Storage, Handling, and Preparation -  Pfizer-BioNTech COVID-19 Vaccine Video (A Guide to Product Handling and Administration at Your Vaccination Center) ° Chapter 1: Storage and Handling ° Chapter 2: Preparation and Administration SAFETY AND HANDLING RESOURCES.................................................................8 - Pfizer-BioNTech COVID-19 Vaccine Shipping and Handling Guidelines Brochures -  Returning Temperature-Monitoring Device and Thermal Shipping Container - Dry Ice Safety Data Sheet - Product Safety Data Sheet DOSING AND ADMINISTRATION RESOURCES.......................................................9 -  A ‘How To Administer the Vaccine’ Poster for Vaccination Providers -  Pfizer-BioNTech COVID-19 Vaccine Video (A Guide to Product Handling and Administration at Your Vaccination Center) ° Chapter 2: Preparation and Administration DRY ICE RESOURCES.......................................................................................... 10 -  Dry Ice Replenishment Requirements Sheet -  Safe Handling Guidelines for Dry Ice Revised: 25 June 2021 1 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 12 years of age and older. SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart. See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com. For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov. DESCRIPTION OF COVID-19 Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. 1 Revised: 25 June 2021 FACT SHEET FOR RECIPIENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 12 YEARS OF AGE AND OLDER You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19. The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19. Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com. WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE WHAT IS COVID-19? COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; uploads/Geographie/ resource-guide-the-pfizer-biontech-covid-19-vaccine 1 .pdf

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