COVID-19 Vaccination Program Interim Playbook For Interim .

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COVID-19 Vaccination ProgramInterim Playbook forCOVID-19 Vaccination dancefor JurisdictionsCenters for Disease Control andPrevention (CDC)September 16, 2020Version 1.0

COVID-19 VACCINATION PROGRAMINTERIM PLAYBOOK FOR JURISDICTIONOPERATIONS – September 16, 2020Table of ContentsExecutive Summary .5Section 1: Public Health Preparedness Planning .6Improvement Planning .6COVID-19 Vaccination Program Planning .6Section 2: COVID-19 Organizational Structure and Partner Involvement.8Planning and Coordination Team (Internal) .8State-Local Coordination .8Tribal Communities .8COVID-19 Vaccination Program Implementation Committee (Internal and External) .9Related Guidance and Reference Materials .9Section 3: Phased Approach to COVID-19 Vaccination . 10Phase 1: Potentially Limited COVID-19 Vaccine Doses Available . 11Phase 2: Large Number of Doses Available; Supply Likely to Meet Demand . 12Phase 3: Likely Sufficient Supply . 12Related Guidance and Reference Materials . 13Section 4: Critical Populations . 14Identifying and Estimating Critical Populations . 14Estimating Population Groups for Initial COVID-19 Vaccine Distribution During Phase 1 . 15Describing and Locating Critical Populations . 15Related Guidance and Reference Materials . 16Section 5: COVID-19 Vaccination Provider Recruitment and Enrollment . 17Vaccination Provider Recruitment . 17Vaccination Provider Enrollment . 18COVID-19 Vaccination Provider Training . 20Role of Commercial and Federal Partners . 21Related Guidance and Reference Materials . 21Section 6: Understanding a Jurisdiction’s COVID-19 Vaccine Administration Capacity . 22Related Guidance and Reference Materials . 23Section 7: COVID-19 Vaccine Allocation, Ordering, Distribution, and Inventory Management . 24Allocation . 24Ordering . 24Distribution . 252 PageVersion 1.0

COVID-19 VACCINATION PROGRAMINTERIM PLAYBOOK FOR JURISDICTIONOPERATIONS – September 16, 2020Inventory Management . 26COVID-19 Vaccine Recovery . 26Section 8: COVID-19 Vaccine Storage and Handling . 27Satellite, Temporary, and Off-Site Clinic Storage and Handling Considerations . 27Section 9: COVID-19 Vaccine Administration Documentation and Reporting . 29Section 10: COVID-19 Vaccination Second-Dose Reminders . 30Section 11: COVID-19 Requirements for Immunization Information Systems or Other External Systems . 31System Infrastructure . 32COVID-19 Vaccination Provider Preparation . 32Data Management . 32Ordering and Inventory . 33Related Guidance and Reference Materials . 33Section 12: COVID-19 Vaccination Program Communication . 35COVID-19 Vaccination Communication Objectives . 35Key Audiences . 35Broad Communication Planning Phases . 35Communication Activities . 36Messaging Considerations . 36Communication Channels . 36Partners and Trusted Sources . 37Crisis and Risk Communication . 37Related Guidance and Reference Materials . 38Section 13: Regulatory Considerations for COVID-19 Vaccination . 39Emergency Use Authorization Fact Sheets . 39Vaccine Information Statements . 39Section 14: COVID-19 Vaccine Safety Monitoring . 40Vaccine Adverse Event Reporting System . 40Vaccine Safety Datalink. 40Clinical Immunization Safety Assessment Project . 40Section 15: COVID-19 Vaccination Program Monitoring. 41CDC Dashboards. 41Resources . 41Messaging . 423 PageVersion 1.0

COVID-19 VACCINATION PROGRAMINTERIM PLAYBOOK FOR JURISDICTIONOPERATIONS – September 16, 2020Local Jurisdictions . 42Appendix A: COVID-19 Vaccination Planning Assumptions for Jurisdictions (revised 9/15/2020) . 43Appendix B: COVID-19 Vaccination Scenarios for Jurisdictional Planning—Phase 1, Q4 2020 (updated 9/15/2020). 47Appendix C: Phase 1 Population Group Worksheet Example . 52Appendix D: CDC IIS Data Requirements for COVID-19 Vaccine Monitoring . 53Appendix E: Countermeasures Injury Compensation Program. 55Appendix F: Liability Immunity for Covered Persons . 564 PageVersion 1.0

COVID-19 VACCINATION PROGRAMINTERIM PLAYBOOK FOR JURISDICTIONOPERATIONS – September 16, 2020Executive SummaryImmunization with a safe and effective COVID-19 vaccine is a critical component of the United States strategy toreduce COVID-19-related illnesses, hospitalizations, and deaths and to help restore societal functioning. The goalof the U.S. government is to have enough COVID-19 vaccine for all people in the United States who wish to bevaccinated. Early in the COVID-19 Vaccination Program, there may be a limited supply of COVID-19 vaccine, andvaccination efforts may focus on those critical to the response, providing direct care, and maintaining societalfunction, as well as those at highest risk for developing severe illness from COVID-19.This document serves as an interim playbook for state, territorial (including the US-affiliated Pacific Islands[USAPI] of American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Federated Statesof Micronesia, the Republic of the Marshall Islands, and the Republic of Palau), and local public health programsand their partners on how to plan and operationalize a vaccination response to COVID-19 within theirjurisdictions. The document’s sections cover specific areas of COVID-19 vaccination program planning andimplementation and provide key guidance documents and links to resources to assist those efforts. Many, butnot all, of the COVID-19 Vaccination Program activities described may overlap with routine activities; routineimmunization and pandemic influenza program activities can serve as a foundation for COVID-19 vaccinationplanning.Centers for Disease Control and Prevention (CDC) Immunization and Vaccines for Children CooperativeAgreement funding recipients (i.e., “awardees”) should use this document to develop their COVID-19vaccination plans. Within their vaccination plans, awardees must address all requirements outlined in theplaybook and clearly describe their responsibility for ensuring activities are implemented. Awardees shouldsubmit their plans to their CDC project officer by October 16, 2020.Information in this interim playbook will be updated as new information (e.g., recommendations for pregnantwomen or pediatric populations) becomes available.5 PageVersion 1.0

COVID-19 VACCINATION PROGRAMINTERIM PLAYBOOK FOR JURISDICTIONOPERATIONS – September 16, 2020Section 1: Public Health Preparedness PlanningPandemic vaccination response planning requires collaboration among a wide range of public- and privatesector partners, including immunization and public health emergency preparedness programs, emergencymanagement agencies, healthcare organizations, industry groups that include critical infrastructure sectors,policy makers, and community vaccination providers (e.g., pharmacies, occupational health settings, doctors’offices). Many of these partners are engaged regularly in seasonal influenza and other outbreak vaccinationcampaigns, and many served as vaccination providers1 during the 2009 H1N1 pandemic. However, significantadditional planning is needed to operationalize a vaccination response to COVID-19, which is much larger inscope and complexity than seasonal influenza or other previous outbreak-related vaccination responses.Following the planning and improvement guidance below can assist in developing a jurisdiction’s baselinereadiness to launch the COVID-19 Vaccination Program.Improvement PlanningImprovement planning is the identification of strengths, areas for improvement, and corrective actions thatresults from workshops, exercises, or real-world events. Jurisdictions should use a consistent approach forimprovement-related activities across each of their COVID-19 vaccination preparedness planning components.Gaps in program planning are often identified when plans are tested, whether through a real event, such as ahepatitis A outbreak, or a full-scale vaccination exercise. Jurisdictions should test their COVID-19 vaccinationprogram plans, and after testing, assign roles and responsibilities with target completion dates for specific tasksto ensure that corrective actions are fully implemented. Periodic review and revision of plans are integral to theimprovement process. Jurisdictions should support continuous quality improvement as they move throughdifferent phases of workshops, exercises, and actual COVID-19 vaccination program implementation, makingand operationalizing improvements in an ongoing manner.COVID-19 Vaccination Program PlanningPrior to plan development, it is important for jurisdictions to have full situational awareness. There are manyunknowns and unanswered questions at this time. For example, it is not yet known which vaccines will beavailable, in what volumes, at what time, with what efficacy, and with what storage and handling requirements.However, jurisdictions should review all current planning assumptions to assist with early planning efforts. (SeeAppendix A: COVID-19 Vaccination Planning Assumptions for Jurisdictions.)In addition to current situational awareness, there is much to learn from past experiences. Jurisdictions may findit helpful to review their 2009 H1N1 pandemic vaccination response plans and lessons learned. After-actionreports and improvement plans from that time provide an opportunity for jurisdictions to build on priorstrengths and determine any gaps that may need to be addressed.After plans have been drafted, it is important to identify any weaknesses by conducting exercises, includingworkshops or tabletop, functional, or full-scale exercises. This may be particularly valuable for any activitiesplanned with external partners. For example, vaccination clinics in temporary or off-site settings, such as thoseplanned for essential workers, are an excellent opportunity for exercises. Specific procedures to assess couldinclude cold chain management, vaccine administration and documentation, traffic flow, or social distancing andsanitation measures. The Federal Emergency Management Agency (FEMA) has posted information on its1For the purposes of this document, “vaccination provider” refers to any facility, organization, or healthcare providerlicensed to possess/administer vaccine or provide vaccination services. A “COVID-19 vaccination provider” is anyvaccination provider who has been enrolled in the COVID-19 Vaccination Program.6 PageVersion 1.0

COVID-19 VACCINATION PROGRAMINTERIM PLAYBOOK FOR JURISDICTIONOPERATIONS – September 16, 2020Homeland Security Exercise and Evaluation program that jurisdictions may find useful as they plan their ownexercises.7 PageVersion 1.0

COVID-19 VACCINATION PROGRAMINTERIM PLAYBOOK FOR JURISDICTIONOPERATIONS – September 16, 2020Section 2: COVID-19 Organizational Structure and Partner InvolvementPandemic vaccination planning is a combined state and local responsibility that requires close collaborationbetween public health, external agencies, and community partners. Depending on the specific jurisdiction’sgovernance structure, the jurisdiction may play a key role in ensuring readiness at all levels. It is imperative thatboth state and local jurisdictions as well as tribal organizations and their planning partners clearly understandeach other’s roles and responsibilities in the COVID-19 Vaccination Program.Planning and Coordination Team (Internal)An internal COVID-19 Vaccination Program planning and coordination team is critical to ensure the vaccinationresponse to COVID-19 is thoughtfully planned and successfully executed. A wide array of expertise should berepresented among team members. Jurisdictions should consider broad inclusion from the immunizationprogram, preparedness program, legal affairs, media/public affairs, and crisis and emergency riskcommunication (see Section 12: COVID-19 Vaccination Program Communication for additional information oncrisis communication planning). In addition, the team should include clinical expertise as well as representativesof programs that serve the early populations of focus (e.g., Bureau of Aging, state licensing board, HIV/AIDSprogram, rural health office). It may even be helpful to include representation from a local public healthjurisdiction for implementation perspective. Team members should be assigned responsibilities based on theirindividual expertise to best enhance plan development and activities coordination before and during theresponse. To mitigate any unexpected situations affecting a team member, each team member should have abackup representative to ensure coverage of each specialty area remains intact throughout the COVID-19Vaccination Program. For any roles that are not adequately staffed, efforts should be made to recruit for and fillany team member vacancies as ea

Sep 16, 2020 · Centers for Disease Control and Prevention (CDC) Immunization and Vaccines for Children Cooperative Agreement funding recipients (i.e., awardees _) should use this document to develop their OVID-19 vaccination plans. Within their vaccination plan

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