The document outlines Georgia's COVID-19 vaccination plan. It discusses 4 phases of vaccine implementation based on availability. Phase 1 has very limited doses for critical populations. Phase 2 has increased doses for more essential workers and high-risk groups. Phase 3 has widespread availability. Phase 4 is recovery. The plan also covers provider enrollment, data reporting, storage/handling, safety monitoring, and ensuring equitable access across the state.
Original Description:
Georgia's vaccine rollout plan
Original Title
COVID-19 Vaccination Plan Georgia-Interim Updated 3.4.2021 (1)
The document outlines Georgia's COVID-19 vaccination plan. It discusses 4 phases of vaccine implementation based on availability. Phase 1 has very limited doses for critical populations. Phase 2 has increased doses for more essential workers and high-risk groups. Phase 3 has widespread availability. Phase 4 is recovery. The plan also covers provider enrollment, data reporting, storage/handling, safety monitoring, and ensuring equitable access across the state.
The document outlines Georgia's COVID-19 vaccination plan. It discusses 4 phases of vaccine implementation based on availability. Phase 1 has very limited doses for critical populations. Phase 2 has increased doses for more essential workers and high-risk groups. Phase 3 has widespread availability. Phase 4 is recovery. The plan also covers provider enrollment, data reporting, storage/handling, safety monitoring, and ensuring equitable access across the state.
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Table of Contents Record of Changes ........................................................................................................................................ 4 Executive Summary....................................................................................................................................... 6 Section 1: COVID-9 Vaccination Preparedness Planning .............................................................................. 9 Introduction .............................................................................................................................................. 9 Purpose ..................................................................................................................................................... 9 Lessons Learned from H1N1 ..................................................................................................................... 9 Section 2: COVID-19 Organizational Structure and Partner Involvement .................................................. 10 Partner Involvement ............................................................................................................................... 10 Core COVID-19 Vaccination Planning Team Members ....................................................................... 10 GDPH’s COVID-19 Vaccine Core Planning & Coordination Organizational Chart ............................... 11 State and Local Partnerships............................................................................................................... 11 Tribal Communities ............................................................................................................................. 12 Roles and Responsibilities ....................................................................................................................... 13 DPH Planning and Coordination Team (The Team) ............................................................................ 13 Section 3: Phased Approach to COVID-19 Vaccination............................................................................... 16 Situation .................................................................................................................................................. 16 General Assumptions for Program Implementation............................................................................... 16 Possession of Vaccines ............................................................................................................................ 17 Authority to Vaccinate during a Public Health Emergency ................................................................. 17 Vaccine Program Implementation Phases .............................................................................................. 18 Phase 1: Limited COVID-19 Vaccine Availability ................................................................................. 18 Phase 2: Increased COVID-19 Vaccine Availability.............................................................................. 19 Phase 3: Vaccine Supply Widely Available .......................................................................................... 20 Phase 4: Recovery/Mitigation ............................................................................................................ 20 Section 4: Critical Populations .................................................................................................................... 21 Data Sources ........................................................................................................................................... 21 Partnerships ............................................................................................................................................ 21 Mapping, Modeling, and Forecasting ..................................................................................................... 22 1|Page GEORGIA INTERIM COVID-19 VACCINATION PLAN
Surveillance Data .................................................................................................................................... 22
Defining Populations ............................................................................................................................... 22 Health Districts and Local Public Health Departments ........................................................................... 24 Section 5: COVID-19 Provider Recruitment and Enrollment ...................................................................... 24 COVID-19 Vaccine Program - Provider Enrollment ................................................................................. 24 Pharmacy Enrollment.......................................................................................................................... 25 Long Term Care Facility Enrollment .................................................................................................... 25 DPH’s “COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy,” sets for the requirements for participation in the COVID-19 Program...................................................................... 25 COVID-19 Provider Training .................................................................................................................... 26 List of Training Topics.......................................................................................................................... 26 Section 6: COVID-19 Vaccine Administration Capacity ............................................................................... 28 Section 7: COVID-19 Vaccine Allocation, Ordering, Distribution, and Inventory Management................. 28 COVID-19 Vaccine Allocation .................................................................................................................. 28 COVID-19 Vaccine Cold Chain Management .......................................................................................... 29 COVID-19 Vaccine Ordering .................................................................................................................... 29 Transfer or Redistribution of Vaccine ..................................................................................................... 30 Vaccine Wastage and Inventory Levels................................................................................................... 30 Section 8: COVID-19 Vaccine Storage and Handling ................................................................................... 30 Individual Provider Locations Responsibilities ........................................................................................ 31 Satellite, Temporary, or Off-Site Settings ............................................................................................... 31 Additional considerations for off-site vaccination clinics ....................................................................... 32 Section 9: COVID-19 Vaccine Administration Documentation and Reporting ........................................... 33 Reporting using IZ Gateway Connect ...................................................................................................... 33 Data Entry and Reporting Monitoring .................................................................................................... 33 Section 10: COVID-19 Vaccination Second-Dose Reminders ...................................................................... 35 Section 11: COVID-19 Requirements for IISs or Other External Systems ................................................... 35 Description of Vaccine Related Data Elements....................................................................................... 35 COVID Vaccine Dashboard - Link............................................................................................................. 36
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Data Exchange and Reporting GRITS Capabilities ................................................................................... 36
GRITS Provider Access – Registration ..................................................................................................... 36 Loss of System or Internet Connectivity ................................................................................................. 36 Data Quality Monitoring ......................................................................................................................... 36 Section 12: COVID-19 Vaccination Program Communication..................................................................... 37 Section 13: Regulatory Considerations for COVID-19 Vaccination ............................................................. 39 Scenario 1: Emergency Use Authorization (EUA).................................................................................... 39 Scenario 2: Licensed Vaccine .................................................................................................................. 39 Section 14: COVID-19 Vaccine Safety Monitoring ...................................................................................... 39 Section 15: COVID-19 Vaccination Program Monitoring ............................................................................ 40 Vaccine Usage and Accountability Administrative Order ....................................................................... 40 Appendix ..................................................................................................................................................... 41 Appendix A: Acronyms ............................................................................................................................ 42 Appendix B: Core COVID-19 Vaccine Planning Team and List of State and Local Partners .................... 43 Georgia Vaccine Task Force ................................................................................................................ 43 Georgia DPH Core COVID-19 Vaccine Planning Team......................................................................... 43 State and Local Partners ..................................................................................................................... 43 Appendix C: Georgia Priority Population Vaccine Allocation Phases ..................................................... 44 Appendix D: Estimating Critical Populations in Georgia ......................................................................... 45 Appendix G: Georgia COVID-19 Vaccine Frequently Asked Questions................................................... 49
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Record of Changes Date of original version: October 2, 2020
Date Reviewed Change Date of Change Description of Change Name of
Number Author 10/15/2020 1 10/16/2020 Transferred to CDC Template S. Lovett 11/6/2020 2 11/05/2020 Added verbiage for Critical N. Dixon Populations 11/6/2020 3 11/05/2020 Added verbiage for Vaccine Storage; T. Dabbs Added verbiage for pharmacy enrollment 11/6/2020 4 11/06/2020 Added verbiage for LTCF enrollment; S. Lovett Added Appendix F 11/6/2020 5 11/06/2020 Updates to Section 12 per CDC E. Jens recommendations A. Tavarez 12/7/2020 6 12/7/2020 Rearranged and formatted Section 2 S. Thomas for better flow 12/7/2020 7 12/7/2020 Added IMT Organization Chart in S. Thomas Section 2 12/7/2020 8 12/7/2020 Added a clearer image in Appendix C S. Thomas 12/7/2020 9 12/7/2020 Revised Phase 1 population section S. Lovett to reflect ACIP Phase 1a recommendation 12/17/2020 10 12/20/2020 Verified, updated, added internal S. Thomas and external links 12/17/2020 11 12/20/2020 Updated Phase 1 populations S. Thomas section to reflect ACIP Phase 1b and 1c recommendations 01/05/20201 12 01/05/2021 Updated Phases populations to S. Lovett include GA’s revised phase 1A+ populations 01/05/2021 13 01/05/2021 Replaced Appendix C with the most N. Nydam current version 01/08/2021 14 01/08/2021 Updated authorized administrators S. Thomas of the COVID-19 vaccine to include Executive Order 01.07.21.01 and PREP Act 01/09/2021 15 01/09/2021 Grammar and layout editing L. Hoffacker 01/10/2021 16 01/10/2021 Updated training and enrollment L. Hoffacker sections, including links. & T. Dabbs
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02/19/2021 17 02/16/2021 Updated to reflect addition of DPH Vaccine
Administrative Order, COVID-19 Team Program policies; new organizational chart; new notification system; new phase description, and deletion of sunset provisions. 2/24/2021 18 02/24/2021 Updates to the FAQ Document S. Lovett 3/4/2021 19 03/04/2021 Addition of eligible populations G Peacock
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Executive Summary The Georgia Department of Public Health (DPH) understands the development of a successful COVID-19 vaccination program requires a strong partnership between federal, state, and local clinical and non- clinical partners. Through these established partnerships and following guidance from the Centers for Disease Control and Prevention (CDC), DPH is working to assure Georgia is prepared and ready to respond once vaccines become available actively.
The H1N1 pandemic demonstrated that well planned and executed mass vaccination efforts are an effective method for addressing and slowing the spread of disease resulting from a naturally occurring pandemic. This statewide Mass Vaccination Distribution and Administration Plan will be used as a state protocol for distributing the COVID-19 vaccine to public health districts and other enrolled COVID-19 pandemic vaccine providers, and overseeing their administration of the vaccine to intended receipients.
Phased Approach to COVID-19 Vaccination
Throughout this response, the main goal will be to assure vaccine distribution and administration processes are in place to begin rapid vaccine administration to Georgia residents once vaccines become available. Current assumptions include a possible imbalance between vaccine demand and supply. Provider sites and vaccine shipments will be prioritized according to the populations those providers serve and the key populations who have been prioritized for the vaccination effort. Critical populations will be prioritized using a phased approach based on assessed level of risk for exposure to or complications from the disease.
Critical Populations
During limited vaccine availability, to define the phases GIP will use CDC ACIP recommendations and the National Academy of Medicine’s Framework for Equitable Allocation of COVID-19 Vaccine as guidance, as well as a combination of existing national, state-wide, and local data sources; engagement of community-based organizations, academic institutions, and state agencies; mapping, modeling, and forecasting; and surveillance data to identify critical and priority populations.
COVID-19 Vaccination Provider Recruitment and Enrollment
DPH began recruiting COVID-19 vaccine providers in August 2020, by releasing a COVID-19 vaccine provider interest survey. Enrollment has since moved to an online process through the Georgia Registry of Immunization Transactions and Services (GRITS). Active recruitment and enrollment of new providers will continue while the COVID-19 vaccine remains available. GIP will lead the COVID-19 vaccine enrollment.
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COVID-19 Vaccine Storage and Handling
Cold chain storage and handling requirements for each vaccine product will vary from refrigerated (2° to 8° C) to frozen (-20°C) to ultra-cold (-60° to -80°C) temperatures, and ongoing stability testing may impact these requirements. Vaccines must be stored appropriately from the time manufactured until administered to a vaccine recipient. While Providers are not being asked to purchase ultracold storage units, all Providers will be required to follow the CDC, ACIP, and manufacturer’s guidance regarding the proper storage and handling of each vaccine. Specific directions for storage temperatures are stated in the vaccine product monograph or on the vaccine product label and checking vaccine product/package is necessary for required storage temperatures. Vaccine products issued under an Emergency Use Authorization (EUA) will have the storage information contained within the authorization.
COVID-19 Vaccination Second-Dose Reminders
Many pharmacies and healthcare organizations have internal systems they use for vaccine recipient notifications and reminders. These Providers are encouraged to utilize these systems for second dose reminders to vaccine recipients. DPH will implement a statewide reminder recall program to support local efforts and providing additional redundancy for second dose reminder methods.
COVID-19 Vaccination Program Communication
Communication plans have been established within the state DPH Crisis and Emergency Risk Communication (CERC) plan. The plan has been vetted, updated, and approved for use in emergencies with an all-hazards approach. The state DPH Division of Communications will lead coordination of communication efforts about vaccine development and availability.
COVID-19 Vaccine Safety Monitoring
DPH has a policy in place for reporting vaccine adverse events following immunization services. The Vaccine Adverse Event Reporting System (VAERS) policy is located in the GIP Manual (Chapter 4), accessible on the GIP website https://dph.georgia.gov/immunization-section/immunization- publications. Providers authorized to administer vaccines are required by law to report to VAERS any adverse event following immunization, including a vaccine administration error. GIP will include VAERS reporting procedure job aids and website information in provider training materials and resources.
COVID-19 vaccine recipients can also conduct vaccine safety monitoring via VSAFE. Providers must inform COVID-19 vaccine recipients about VSAFE. VSAFE is a new voluntary, smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins for COVID-19 vaccine recipients. V-safe allows vaccine recipients to report any side effects after administration of the COVID- 19 vaccination to CDC in almost real-time. It also gives vaccine recipients a convenient reminder to get
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their second COVID-19 vaccine dose at the appropriate time.. https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/safety/vsafe.html
COVID-19 Vaccination Program Monitoring
DPH will assume responsibility for continuous monitoring for vaccine-related situational awareness throughout COVID-19 vaccination response activities. To do so, DPH has developed a “COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy,” with a corresponding “Acceptance of COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy.” With the “Georgia Department of Public Health Administrative Order for Public Health Control Measures,” DPH has orderd Program Providers to comply with the Policy subject to penalties and/or corrective action.
A safe and effective COVID-19 vaccine is a critical component in reducing COVID-19 related illnesses, hospitalizations, and deaths, and will help restore a sense of normalcy nationally. DPH understands the development of a successful COVID-19 vaccination program requires a strong partnership among federal, state, and local clinical and non-clinical partners. Through these established partnerships, following guidance from the Centers for Disease Control and Prevention (CDC), DPH is working to assure Georgia is prepared and ready to respond once vaccine(s) becomes available actively.
The H1N1 pandemic demonstrated that well planned and executed large scale vaccination efforts are an effective method for addressing and slowing the spread of disease resulting from a naturally occurring pandemic. DPH developed the statewide COVID-19 vaccine administration and distribution plan using several resources, including best practices learned from past H1N1 pandemic response activities, the Georgia “DPH Pandemic Response Plan – Support Annex K: Mass Vaccination Distribution Plan,” the CDC’s “COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations,” and other pandemic influenza planning guidance and tools. Understanding this is a situation that may continue to evolve, DPH will review, update, and share revised versions of its vaccine administration and distribution plan as additional information is received and process improvements are identified.
Purpose
This statewide Mass Vaccination Distribution and Administration Plan will be used as a state protocol for distributing and administering the COVID-19 vaccine to public health districts and other enrolled COVID- 19 pandemic vaccine providers. In combination with the GIP Manual, Mass Vaccination Section, this plan will serve as the framework and guidance for districts and counties to create their detailed plans, which should be tailored to meet the needs of individual communities.
Lessons Learned from H1N1
Lessons learned from DPH’s H1N1 vaccination response will be used to inform the COVID-19 vaccination response. Some of these key lessons include:
• Vaccine supply and availability may be sporadic in the initial phases of a pandemic response. • DPH must be able to scale down plans based on the degree of community spread. • Communication with providers is as essential as communication with staff. • Staff cross-training is essential. • The “push” method of vaccination was more effective during this event than the “pull” method. That is, a higher portion of the population was served by establishing mass vaccination clinics in
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popular, high traffic areas instead of holding the clinics in geographically unfamiliar clinical settings. • Collaboration with the Department of Education provided for a higher rate of vaccination in Georgia’s population. • Full-scale mass vaccination sites would be more effective with additional human resources. • Need to be flexible and recognize the variability that is inherent in pandemics and to be able to plan and respond accordingly
Section 2: COVID-19 Organizational Structure and Partner Involvement
Local and state agencies and organizations have specific roles and responsibilities during public health emergencies. A complete list of these roles and responsibilities can be found within the DPH, Emergency Preparedness and Response (EPR) Emergency Operations Plan (EOP). The EOP defines the roles and responsibilities related to mass vaccination distribution and administration response efforts.
Partner Involvement
Core COVID-19 Vaccination Planning Team Members
DPH has established a COVID-19 Vaccine Core Planning and Coordination Team (COVID-19 Team). The COVID 19 Team will be responsible for the annual review of state plans, updating plans during an active response, and distributing updated plans to partners and stakeholders.
A complete list of the COVID-19 Team members is found in Appendix B. The Team membership may be revised throughout this response. In addition to DPH’s Immunizations and Emergency Preparedness staff, representation from each of the following offices are active participants of this team:
• Office of General Counsel: Office of General Counsel will provide legal guidance and counsel and assist in applying and adhering to federal and state laws and regulations throughout the incident. Please see the Disease Exposure Control Plan (DEC), DPH EOP, Annex P • Office of Emergency Medical Services and Trauma (EMS): EMS will communicate training requirements, information, data reporting requirements, etc., to EMS services throughout the state via the Regional EMS Directors. • Office of Nursing (OON): OON will coordinate with County Nurse Managers and district Nursing Directors throughout the state to assure appropriate staffing of Mass Vaccination Clinics (MVC). • Office of Pharmacy: Pharmacy will collaborate with the districts and support the Pharmacy Disaster Response Coordinator pharmacist as outlined under Roles and Responsibilities in the DPH, EOP.
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Collaboration between state and local public health, other state agency partners, private immunization providers, and immunization stakeholders is key to vaccine response efforts. A comprehensive list of crucial collaborating partners for this response activity is included in Appendix B. This list may be updated as additional collaborations are established.
DPH has identified staff to serve as primary and back-up for each of the roles outlined here. Each district will identify primary and back-up staff members responsible for each position:
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• Vaccine Safety Coordinator: Assure public health staff is trained on the proper administration, storage, and handling of the vaccine. Also, train on treating adverse events and reporting them through the Vaccine Adverse Event Reporting System (VAERS) on-line. • Reporting Coordinator: Contact for reporting responsibilities as determined per state/federal requirements. The assumption should be that all doses administered will be submitted (via an interface or direct entry) into the Georgia Registry of Immunization Transactions and Services (GRITS). • Medical Countermeasures Coordinator: Manages and coordinates receipt of supplies and medications at the Receive, Stage and Store Warehouse (RSS). Recruits and supports closed Point(s) of Distribution (POD) and MVC partners throughout their enrollment and administration activities. • Vaccine Logistics Manager: Documents vaccine supply and inventory and coordinates shipments to other sites, if needed.
Tribal Communities
Collaboration with federally and state-recognized tribal communities is essential for reaching one of this response’s priority populations. While Georgia has no federally recognized tribes or Indian Health Service tribal (HIS) facilities within the state, response outreach will center on state-recognized tribes that are primarily informally organized. GIP has reached out to local tribal organizations for collaborative activities and will continue to make inroads to sustainable immunization partnerships.
There are no healthcare organizations primarily serving American Indian individuals in Georgia. Most tribal members are not concentrated on reservations, contributing to challenges faced when working to assess population estimates for this priority group. For example, one of Georgia’s three tribal groups only has one member living within Georgia. In contrast, the other members cross back and forth across the Georgia/Florida state line, living primarily in Florida. GIP will continue efforts to gather the number of populations served in tribal communities, as well as assess need and resources available to establish MVCs/PODs within these areas using the following methods:
• Work with regional health districts, local health departments, and tribal councils to gather data on the number of tribal members to estimate better the number of vaccines needed to support this population. • Continue to support district and local county health departments with COVID-19 vaccine educational and vaccination outreach efforts targeting this population in the absence of tribal medical facilities. • Continue to support private vaccination providers with COVID-19 vaccination and vaccine educational outreach serving Georgia’s Native American populations and other rural populations.
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• Continue to reach out to tribal partners, solidify connections with local tribal leaders, and support tribe-originated needs for the COVID-19 vaccine.
Roles and Responsibilities
DPH Planning and Coordination Team (The Team)
The PH COVID-19 Vaccine Core Planning and Coordination Team (the Team) will be responsible for the annual review of state plans, updating plans during an active response, and distributing updated plans to partners and stakeholders. Primary responsibilities of this core team include: • Assuring Mass Vaccination Distribution and Administration Plan is in alignment with the current version of the GIP Manual and Nursing Protocols and current federal guidance so that all resources communicate a consistent message; • Using cross-team collaboration (emergency preparedness, immunization, pharmacy, nursing, communications, and field operations) in the development of plans, protocols, and guidance; • Determining and communicating the priority populations based on Emergency Use Authorization (EUA) guidance, Advisory Committee on Immunization Practices (ACIP) recommendations, and CDC guidelines, contingent upon current issues and available guidance relative to those issues. o FDA authorized a EUA for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, https://www.cdc.gov/vaccines/covid-19/eua/index.html. The CDC’s ACIP released interim recommendations for the vaccine on December 12, 2020, https://www.cdc.gov/mmwr/volumes/69/wr/mm6950e2.htm. o FDA authorized a EUA for Moderna COVID-19 vaccine on December 18, 2020, https://www.modernatx.com/covid19vaccine-eua/. The CDC’s ACIP released interim recommendations for the vaccine on December 20, 2020. https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm • Communicating vaccination planning efforts and priority population specifications to the Governor, legislators, medical societies, other state agencies, state-level provider organizations, and other stakeholders as needed; • Providing guidance and technical support on planning for COVID-19 vaccine-related activities to district and local public health partners and all other COVID-19 pandemic providers; • Engaging and facilitating registration of statewide provider networks, such as chain pharmacies, hospitals, long-term care facilities, correctional facilities, primary care providers, and other other potential vaccination providers.
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• Providing training on vaccine storage and handling, data submission to GRITS, and adverse event reporting to non-public health providers. Conduct train-the-trainer sessions with identified public health district personnel for continued training of local-level public health staff; • Developing a method for allocating vaccines to each public health district and other providers, which will depend on population density, level of disease endemic to each district, and the number of priority populations; • Coordinating the direct distribution of vaccine to each district or county public health provider and registered non-public health providers with approved vaccine storage units and capacity; • Using the proper method of cold chain transport when assisting with vaccine transport between vaccinating sites; • Planning for receiving and reporting aggregate data back to the CDC through GRITS generated reporting mechanisms; • Providing social distancing guidance for vaccination operations following the state Disease Exposure Control (DEC) plan and current CDC guidelines for the protection of staff and those participating in the vaccination campaigns; • The DPH Communications Office will provide key guidance and talking points and disseminate public service announcement language to support statewide campaigns; and • Providing guidance to key state partners working with vulnerable populations.
DPH District Responsibilities
Public Health Districts have developed plans to utilize Points of Distribution for Medical Countermeasures and Administration and Medical Materiel Management and Distribution. Public Health districts are to utilize Points of Distribution (PODs) as Mass Vaccination Clinics (MVCs) for the SARS-CoV2 (COVID-19) mass vaccination campaigns. Primary responsibilities include:
• Develop a COVID-19 Mass Vaccination Distribution and Administration Plan following state guidance that best meets each community's needs within its geographical boundaries, maximizing efficiency in the use of resources. • Engage and encourage registration of partner providers to assist in vaccinating all priority populations. • Collaborate with community partners (local colleges, schools, and/or large childcare facility personnel) to assure access to vaccination for priority populations. • Develop and implement closed MVCs for vaccination clinics, as staffing and other resources allow. • Explore other nontraditional venues for vaccine administration, such as retail settings, faith- based facilities, and occupational settings.
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• Comply with all reporting requirements, including interim reports of vaccination planning and implementation activities specific to each event. • Each district or county will have agreements and contracts with the local police department to help secure vaccines and maintain order at mass vaccination sites. Emergency Response plans will be in place at each location. • Districts will have standing operating procedures (SOPs) for each vaccination site. The CDC recommends facilities develop and maintain written, detailed, and up-to-date storage and handling SOPs. SOPs should be reviewed by all staff and updated by the vaccine coordinator. SOPs should contain plans and information for three major areas: • General information – include contact information for vaccine manufacturers, equipment service providers, and essential facility staff, as well as job descriptions, regularly used forms, and staff training requirements. • Routine storage and handling – include information for all aspects of vaccine inventory management, from ordering to monitoring storage conditions. • Emergency vaccine storage, handling, and transport – outline the steps to be taken in the event of equipment malfunctions, power failures, natural disasters, or other emergencies that might compromise vaccine storage conditions. • Adhere to storage and return guidelines for manufactures’ thermal shippers. Pfizer: https://contlogo.s3.eu-central- 1.amazonaws.com/Pfizer/Thermal%20Shipper%20Return%20Guidance.pdf • Video: https://www.cvdvaccine-us.com/product-storage-and-dry-ice Moderna: https://eziz.org/assets/docs/COVID19/2020DecMcKessonVaccineShipperReturnInst ructions.pdf More details regarding the development of SOPs are available in the CDC’s Vaccine Storage and Handling Toolkit: https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html
• Each Public Health MVC will obtain informed consent for every patient before vaccination. • Each public health district/county health department/partner provider will have access to and distribute the COVID-19 EUA Fact Sheet or Vaccine Information Statement (VIS) document before administering each vaccine, following federal law. • Every provider's responsibility is to obtain and distribute an approved EUA and VIS, as required, to each vaccine recipient, the adult caregiver accompanying the recipient, or other legal representatives via electronic or printed materials. • Each district is responsible for the advertising of priority populations and sites of the PODs/MVCs.
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Section 3: Phased Approach to COVID-19 Vaccination
Early vaccine program assumptions support a phased implementation of COVID-19 vaccination response activities. During limited vaccine availability, GIP will utilize CDC ACIP recommendations and the National Academy of Medicine’s Framework for the Equitable Allocation of COVID-19 Vaccine. As additional information is received, we will adjust our plan outlined below accordingly.
Situation
DPH will receive allocations of COVID-19 vaccines from the federal government. The vaccine will be distributed using the current Vaccines for Children (VFC) vaccine distribution infrastructure. This distribution mechanism will allow vaccines to be shipped directly to providers who have enrolled as COVID-19 vaccine providers. If a provider cannot store or administer minimum shipping quantities during the designated time frame, DPH will provide vaccines for these sites through an approved redistribution location. As an additional backup to the VFC distribution method, the vaccine may be sent to Georgia’s Receipt Stage and Store (RSS) warehouse (location will not be disclosed in the plan due to security).
General Assumptions for Program Implementation
The main goal is to assure vaccine distribution and administration processes are in place to begin rapid vaccine administration to Georgia residents once vaccines become available. Current assumptions include a possible imbalance between vaccine demand and supply. Provider sites and vaccine shipments will be prioritized according to the populations those providers serve and the key populations who have been targeted for the vaccination effort. A copy of the Georgia Priority Population Vaccination Allocation Matrix is attached hereto as Appendix C.
DPH Allocation Team will decide the amount of vaccine given to each of the 18 public health districts and enrolled COVID-19 providers based on population density, level of disease endemic to each area, priority populations, social vulnerability index, type of providers and ability to use Pfizer, Moderna, Janssenor multiple vaccine types, vaccine administration rates and on hand inventory, based on available vaccine supply. Additional information related to the vaccine allocation method is included in Section 7 of this plan.
For mass vaccination, the state will consider recommendations from the ACIP. These recommendations are the most current guidelines regarding vaccine administration, storage and handling, and safety. The ACIP details guidance for the administration of all routinely administered vaccines. Recommendations for each vaccine are updated as needed. Current copies of recommendations of the ACIP for each vaccine are located on the following CDC website: https://www.cdc.gov/vaccines/covid-19/info-by- product. Each public health facility that administers vaccines must have a written copy of the ACIP recommendations or internet access to the above website.
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DPH will also disseminate recommendations and guidance via the GIP Manual. This manual provides guidance for routinely ordering, storing, handling, and administering vaccines and providing immunization related services. The manual also includes quality assurance standards and standard operating guidelines for conducting mass vaccination clinics (MVCs). The manual is updated at least annually and can be accessed at https://dph.georgia.gov/immunization-publications. Georgia Public Health districts may use Point of Distribution (POD) locations and plans to conduct MVCs.
Possession of Vaccines
In addition to the enrollment requirements included in Section 5 of this plan, Providers must meet “one” of the following legal requirements to receive an allocation of vaccine:
• Must be able to possess dangerous drugs following O.C.G.A.§ 16-13-72 and must meet the definition of “pharmacist” or “pharmacy” as defined by O.C.G.A. § 26-4-5(28) or as defined by O.C.G.A §26-4-5(30). • Must be able to possess dangerous drugs following O.C.G.A § 16-13-72 and must meet the definition of “practitioner” or “practitioner of the healing arts” as defined by O.C.G.A. § 26-4- 5(33). • A nurse acting pursuant to an influenza vaccine protocol agreement as provided by O.C.G.A. § 43-34-26.1 and meets the definition of a “nurse” as defined in 43-34-261 (a) (7). “The nurse (RN or LPN) must be regularly employed by a physician who is actively employed in private practice.” • Must be able to possess dangerous drugs following O.C.G.A § 16-13-72 and meet the definition of “advanced practice registered nurse” as defined by O.C.G.A.§ 43-34-25 and acting pursuant to an influenza vaccine “protocol agreement” following O.C.G.A. § 43-34-25. • Must be able to possess dangerous drugs as defined by O.C.G.A. § 16-13-72 and meet the requirements of O.C.G.A. § 43-34-103, meet the definition of “Physician Assistant” as defined by O.C.G.A. §43-34-102 and be acting pursuant to an influenza vaccine “job description” following O.C.G.A. §43-34-102.
Authority to Vaccinate during a Public Health Emergency
• Under Georgia law and/or an Executive Order issued by Governor Brian Kemp, the following health professionals are authorized to administer vaccines: : • Physicians – O.C.G.A. § 43-34-21, et. seq. • Pharmacists - O.C.G.A. § 26-4-4, 26-4-5(30)(A) and (31), O.C.G.A. §43-34-26.1; Executive Order – November 30, 2020.1 • Certified Emergency Medical Technicians - O.C.G.A. § 31-11-53; Executive Order January 7, 2021.02 • Paramedics - O.C.G.A. § 31-11-54; Executive Order January 7, 2021.02
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• Certified Cardiac Technicians - O.C.G.A. § 31-11-55; Executive Order January 7,
2021.02 • Dentists - O.C.G.A. § 43-11-1 (5) and § 43-11-17 – Executive Order January 15, 2021.01. • Certified Medical Assistants – - O.C.G.A. § 43-34-44; Executive Order January 22, 2021.07. • Licensed Practical Nurse (LPN) - O.C.G.A. § 43-26-3(6) and § 43-34-23(7) - Executive Order January 22, 2021.07. • Retired Nurses - Executive Order January 22, 2021.07. • Registered Professional Nurse (RN) - O.C.G.A. § 43-26-3(6) and (8), O.C.G.A. § 43-34- 26.1(c) and O.C.G.A. § 43-34-23(a)(6 - 8) and (b)(2) • Advanced Practice Nurses: Certified Nurse Midwife, Certified Registered Nurse Anesthetist, Nurse Practitioner, and Clinical Nurse Specialist - O.C.G.A. § 43-26-3(1), (6) and (8) and § 43-34-23(b)(1)(B) • Physician Assistant (PA) - O.C.G.A. § 43-34-105 and O.C.G.A. §43-34-23(b) (1-2) - Executive Order January 22, 2021.07. • Medical Student, Intern or Resident - O.C.G.A. § 43-34-22(b)(9)(A) and O.C.G.A. § 43- 34-26(a)(3) The Code does not give the following professionals authority to administer drugs and no such authority has been given to them by Executive Order:
• Acupuncturists - O.C.G.A. § 43-34-62 (1) and (4)
The U.S. Department of Health and Human Services has issued an emergency declaration allowing pharmacists and pharmacist interns to become “covered persons” under the Public Readiness and Emergency Preparedness Act (PREP Act). To read more about the PREP Act and this emergency declaration, please visit https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
Vaccine Program Implementation Phases
Phase 1: Limited COVID-19 Vaccine Availability
COVID-19 vaccine supply is expected to be limited during the initial implementation of vaccine response activities (Phase 1). During this phase, vaccine efforts will focus on reaching defined critical populations who meet DPH defined Phase 1 criteria. Vaccine administration will occur through vaccination sites, including, but not limited to, public health clinics, hospitals, long term care facilities (LTCFs), emergency medical services (EMS), private providers, pharmacies, etc.
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The below list of Phase 1 populations is not all-inclusive and will be reviewed and updated throughout the response as needed:
1. Healthcare personnel likely to be exposed to or treat people with COVID-19
2. First Responders 3. People at increased risk for severe illness from COVID-19, including those 65 years of age and older’; and 4. Staff and residents of Long Term Care Facilties;
Initial vaccine supply may not be enough to maximize access for the entire Phase 1 population. ACIP recommends that healthcare personnel be prioritized in the earliest phase of COVID-19 vaccination (https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm). However, in settings where the initial vaccine supply is insufficient to vaccinate all healthcare providers, sub-prioritization of vaccine doses may be necessary. Considerations for sub-prioritization of equal importance include but are not limited to:
1. Phase 1-A+ will include paid and unpaid persons serving in a healthcare setting with the potential for direct or indirect exposure from patients or infectious materials. Hospital staff, public health clinical staff, EMS, and other first responders, long term care facility (LTCF) staff, and urgent care facility staff are examples of people who are included in this Phase. Additional examples include: a. Healthcare workers (e.g., physicians, nurses, pharmacists, EMS, laboratory staff, environmental services, etc b. LTCF staff and residents c. Adults 65 and older and their caregivers d. Law enforcement, fire personnel (e.g., volunteer fire departments), dispatchers, 9-1- 1 operators, etc.) 2. Eligible populations will be defined and added as more vaccine becomes available.
For more specific details on Georgia’s Priority Population Groups, please see Appendix C. Phase 2: Increased COVID-19 Vaccine Availability
As vaccine availability increases, vaccine response efforts will also expand to assure vaccination of Phase 1 critical populations not yet vaccinated, as well as members of the population for whom vaccine has been recommended.
Additional eligible populations will be added beginning March 8, 2021.
These include:
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o Adults with intellectual and developmental disabilities and their caregivers
o Educators and staff (Pre-school, K-12, DECAL licensed or exempt childcare) o Caregivers of Children with Medically Complex Conditions
For more specific details on Georgia’s Priority Population Groups, please see Appendix C.
Phase 3: Vaccine Supply Widely Available
COVID-19 vaccination activities will transition to Phase 3 response once vaccines become widely available. Planning for this phase assumes that vaccine supply exceeds demand, and access to vaccines are available through a variety of Providers..
Phase 3 is currently in the process of being defined.
For more specific details on Georgia’s Priority Population Groups, please see Appendix C.
Phase 4: Recovery/Mitigation
The critical activities of recovery include, but are not limited to:
1. Assure accurate documentation of reported adverse events and doses administered.
2. Return surplus vaccine following federal guidelines. 3. Follow the Strategic National Stockpile (SNS) and Medical Countermeasures (MCM) Plans, as needed. 4. Document lessons learned and adjust vaccination plans based on lessons learned.
Mitigation minimizes the adverse impact of an emergency and reduces vulnerability to future emergencies. Mitigation measures may be implemented at any time. Mitigation includes: 1. Continued vaccination campaigns to reduce the risk of infection; 2. Continued public information and education; and 3. Regular training and exercises to improve public health’s ability to respond to future outbreaks and pandemics.
For more specific details on Georgia’s Priority Population Groups, please see Appendix C.
Based on available clinical trial data, COVID-19 vaccination is expected to cause systemic post- vaccination symptoms, such as fever, headache, and muscle pain at the injection site. While the incidence and timing of post-vaccination symptoms will be updated with available clinical trial data, strategies are needed to mitigate possible healthcare personnel absenteeism and resulting personnel shortages due to the occurrence of these post-vaccination symptoms. Considerations might include:
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• Staggering of delivery of the vaccine to healthcare personnel in a facility so that personnel from a single department or unit are not all vaccinated simultaneously. Based on greater reactogenicity observed following the second vaccine dose based on current clinical trial data, staggering considerations may be more critical following the second dose; and
• Planning for personnel to have time away from work if they develop systemic symptoms following a COVID-19 vaccination.
Section 4: Critical Populations
During limited vaccine availability, GIP will utilize CDC ACIP recommendations and the National Academy of Medicine’s Framework for Equitable Allocation of COVID-19 Vaccine to identify, estimate the numbers of, and locate critical populations for COVID-19 vaccine distribution. GIP will use a combination of a) existing national, state-wide, and local data sources; b) engagement of community- based organizations, academic institutions, and state agencies and c) mapping, modeling and forecasting, and d) surveillance data. All information collected on critical populations (i.e., estimate and data source) will be compiled into a Critical Populations (Appendix D) database maintained by DPH. In addition to DPH identifying, estimating, and locating critical populations, each of the 18 health districts will be required to identify data sources to assess critical populations in their respective areas. The information from local public health will be collected at the state-level and compared to state estimates.
Data Sources
DPH will establish a list of currently available data sources that estimate the numbers of critical populations. The current data sources include, but are not limited to, the Cybersecurity and Infrastructure Security Agency (CISA), the U.S. Census, Medicare, and Medicaid. Additionally, Georgia’s Online Analytical Statistical Information System (OASIS) will be used to estimate and locate critical populations. OASIS is a suite of interactive tools used to access the Georgia Department of Public Health’s standardized health data repository. Additional data sources are described below.
Partnerships
1. Professional Organizations/Societies, State Agencies, Academic Institutions,
Licensing/Regulatory Boards, etc.: DPH has established relationships with professional organizations/societies, state agencies (e.g., Department of Community Health, Georgia Emergency Management Agency), academic institutions, and licensing/regulatory boards. DPH will work with these organizations and groups to gather their current data on specified critical populations.
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commit to locate and reach vulnerable populations to provide services while accommodating language, cultural, and accessibility needs. They offer day-to-day services and often have earned the trust of the individuals they serve. Hence, they can also provide an accurate barometer of needs and mobilize the community and local resources. DPH has established relationships with CBOs at both the state and local levels. The DPH will work closely with CBOs to identify the population they serve and collect current data on the specified population. Additionally, some CBOs have begun utilizing neighborhood or geographic information systems (NIS or GIS) to locate their target population. Therefore, DPH will work with CBOs to collect this data to find critical populations.
3. COVID-19 Health Equity Team: In response to the pandemic, DPH has established a COVID- 19 Health Equity Team. The team has been engaging CBOs to address health inequities exacerbated by COVID-19. DPH will utilize the current partnerships created by this team to collect estimates on critical populations and locate them.
Mapping, Modeling, and Forecasting
DPH will partner with academic institutions to conduct risk assessments to identify and categorize subset groups. Assessments will include geospatial analysis, modeling, mapping communities, the burden of disease, access to testing, vaccine providers, and places of employment to identify groups at the highest risk for disease or severe illness and available resources. Additionally, DPH will partner with the Georgia Emergency Management Agency (GEMA) to map current vaccination providers to identify areas and communities where vaccination services are scarce.
Surveillance Data
DPH will analyze COVID-19 surveillance data to identify, estimate, and locate critical populations in Georgia. Analyzing surveillance data will allow public health to identify vulnerable populations at the most significant risk for disease and more severe outcomes. Additionally, examining outbreak surveillance data will
Defining Populations
DPH uses the U.S. Department of Homeland Security
(https://www.cisa.gov/sites/default/files/publications/Version_4.0_CISA_Guidance_on_Essential_Critica l_Infrastructure_Workers_FINAL%20AUG%2018v3.pdf) as guidance to define the essential critical infrastructure workforce. However, state officials will decide the final classification of a group as an essential critical infrastructure workforce in Georgia. To estimate the number of essential workers in Georgia, DPH will utilize a combination of, but not limited to, national (census), state, and local data sources, and data from professional organizations and licensing boards (Appendix D). 22 | P a g e GEORGIA INTERIM COVID-19 VACCINATION PLAN
1. The definition of essential critical infrastructure workforce established by DPH will be provided to key stakeholders including, but not limited to, local public health departments, healthcare providers, professional societies/organizations, pharmacists, academic institutionsetc. If there is insufficient vaccine supply, GA DPH will utilize ACIP guidance, pre-established, evidenced- based priority categories and definitions, and state-specific COVID-19 surveillance data to identify different subset groups of critical populations in Georgia. Considerations for identifying subset groups include, but are not limited to, occupational risk, the burden of disease, vulnerability to severe illness, residential setting (i.e., congregate), geographical location, and equity. To assure an equitable framework for vaccination allocation, DPH will consider the following criteria proposed by CDC and the National Academy of Medicine:
• Risk of acquiring infection: Higher priority given to individuals who have a greater probability of being in settings where COVID-19 is circulating and exposure to the virus. • Risk of severe morbidity and mortality: Higher priority given to individuals with a greater probability of severe disease or death if they acquire infection. • Risk of negative societal impact: Higher priority is given to individuals with societal function. Upon whom other people’s lives and livelihood depend directly and would be imperiled if they fell ill. It does not consider their wealth or income or how readily an individual could be replaced in a work setting, given labor market conditions. • Risk of transmitting the disease to others: Higher priority is given to individuals who have a higher probability of transmitting the disease.
Considering these factors, DPH will work with state officials to establish subset groups of critical populations. When a person is included in more than one group, they will be prioritized for vaccination in the highest Phase group in which they are included.
Additionally, DPH will partner with academic institutions to conduct risk assessments to identify and categorize subset groups. Assessments will include geospatial analysis, modeling, mapping communities, disease burden, access to testing, and vaccine providers to identify groups at the highest risk for disease or severe illness and available resources.
Through COVID-19 disease surveillance and the development of COVID-19 guidance, the GA DPH has established relationships with academic institutions, government agencies, professional organizations, various industries (e.g., poultry plants, manufacturers, and warehouse distribution companies), healthcare organizations, jails, detention centers, employers, and community-based organizations (CBOs). To establish points of contact (POC) with critical populations, the DPH will utilize existing relationships, state-based listservs, and POCs. Additionally, the established POCs and listservs will be used to identify and engage supplementary POCs. DPH’s COVID-19 Health Equity Team will assist in identifying additional POCs, focusing primarily on CBOs. An up-to-date communication distribution list of organizations, healthcare providers, agencies, and POCs will be maintained throughout vaccine
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distribution to assure consistent communication with key stakeholders. When appropriate, essential COVID-19 vaccine information for critical populations will be provided on the DPH website; health advisory notices, communication materials, and relevant updates for critical populations will be placed on DPH’s webpage and updated as necessary.
Health Districts and Local Public Health Departments
Georgia’s 18 Health Districts and local public health departments have established relationships with local community partners, healthcare organizations, long-term care facilities, businesses, industries, and professional organizations. Each district will be required to establish POCs for key critical populations to a) identify and locate critical populations in their geographic area and b) communicate timely and effective COVID-19 vaccination messaging. Districts will be required to complete a district-specific “Population Group Worksheet” (Appendix E) and submit it to DPH.
Section 5: COVID-19 Provider Recruitment and Enrollment
In partnership with Emergency Preparedness, GIP began the first phase of COVID-19 provider recruitment on August 12, 2020, by disseminating recruitment letters to external partners; Health Districts, currently enrolled Vaccines for Children (VFC) providers, and previous H1N1 mass vaccination providers. Each letter was tailored to address further recruitment instructions based on provider type and provided a link for providers to complete a COVID-19 Vaccine Pre-Enrollment Questionnaire through survey monkey was provided.
The recruitment process has now moved to an online enrollment process on GRITS. The process will include a review of submitted applications to place interested providers into three Phases. Phases will be assigned based on providers’ ability to store and handle vaccines with documented completed training, followed by their capability of being a mass vaccination site for each of the three population Phase phases outlined by the CDC. GIP will use a phased approach to enroll providers in the COVID-19 vaccine program. Active recruitment and enrollment of new providers will continue while the COVID-19 vaccine remains available.
For more information about how to enroll, please visit https://dph.georgia.gov/covid-vaccine-
information-providers.
COVID-19 Vaccine Program - Provider Enrollment
The GIP Program will lead the COVID-19 vaccine enrollment activities. COVID-19 vaccine providers may enroll by completing the Provider Profile and Provider Agreement on GRITS (https://www.grits.state.ga.us/). The “COVID-19 Program Provider Accountability and Waste Avoidance Policy” should be reviewed for specific terms and conditions of enrollment. The Provider’s --------- must sign the “Acceptance of COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy.” The organization’s chief medical officer (or equivalent) and chief executive officer (or chief 24 | P a g e GEORGIA INTERIM COVID-19 VACCINATION PLAN
fiduciary) must complete and sign the CDC COVID-19 Vaccination Program Provider Requirements and Legal Agreement. CDC’s COVID-19 Vaccination Program Provider Profile Information must be completed for each vaccination location covered under the organization. The provider agreement and medical licenses or certification must be submitted for each health professional who will administer vaccine.
There must be a signed CDC COVID-19 Vaccine Redistribution Agreement for any facility/organization approved by DPH to conduct vaccine redistribution and a fully completed CDC COVID-19 Vaccination Provider Profile Information form (Section B of the CDC COVID-19 Vaccination Program Provider Agreement) for each receiving vaccination location.
The COVID provider enrollment assessment period lasts approximately three weeks for program requirement review and approval of your storage equipment (See Section 8 for specific vaccine storage and handling guidance).
Pharmacy Enrollment
Participation by pharmacy partners will be a key component of vaccine distribution. Pharmacy partners not served directly by the CDC will receive information through DPH’s Office of Pharmacy, the Pharmacy Disaster Response Coordinator pharmacist, the Georgia Board of Pharmacy, and respective state pharmacy associations regarding provider enrollment and vaccine guidance with support from the Office of Immunization.
Long Term Care Facility Enrollment
As part of a national vaccination strategy, all long-term care facilities had three options for assuring vaccination coverage for staff and residents.
• Facilities with the capacity to facilitate vaccination clinics for staff and residents, without external assistance, complete enrollment instructions as outlined above and register through GRITS to serve as a COVID-19 vaccination provider site. • Enrollment in the Pharmacy Partnership for Long Term Care Program. Through this program, which is being phased out, CDC engaged two retail pharmacies, CVS and Walgreens, to secure the COVID-19 vaccine and provide onsite vaccination of residents at no cost to the facility. • Leverage existing partnerships with local pharmacies, county public health clinics, etc., to provide vaccines for facility staff and residents. COVID-19 Vaccine Program Requirements for Providers
DPH’s “COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy,” sets for the requirements for participation in the COVID-19 Program.
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COVID-19 Provider Training
GIP has a list of training topics and a method for tracking provider training requirements through provider enrollment and quality assurance and improvement processes. Provider training requirements are located in the state GIP Manual in the Quality Assurance/Quality Improvement (QA/QI) section (Chapter 13). The learning expectations are based on the ACIP recommendations that outline the recommended Policies and Procedures for administering vaccines and providing immunization services by Registered Nurses (RNs) and Licensed Practical Nurses (LPNs) in a public health setting. The QA/QI tool is used to document the training/education expectations and clinical practice parameters for immunization services. The training tool is used to promote consistency in practice across programs on a statewide basis, provide an opportunity to identify excellence in practice, and provide opportunities for improvement. The training list and learning expectations will apply to all enrolled COVID-19 vaccine providers. Under Georgia’s authority to administer vaccines during a state public health emergency, the training list and the QA/QI section of the GIP manual will be updated to include CDC guidance for COVID- 19 vaccine(s) administration.
List of Training Topics
Before administering the COVID-19 vaccine, the learner will complete the following “You Call the Shots” CDC training modules: https://www2.cdc.gov/vaccines/ed/covid19/
1. COVID-19 Vaccine Training: General Overview of Immunization Best Practices for Healthcare Providers Understanding the Basics: The objective of this module is to provide healthcare providers with information about COVID-19 vaccine Emergency Use Authorization and safety, as well as general information about vaccine storage, handling, administration, and reporting. Training is available at https://www2.cdc.gov/vaccines/ed/covid19.
2. Storage and Handling of COVID-19 Vaccines: The Vaccine Storage and Handling (1.0hr) training module is available on the CDC website https://www2.cdc.gov/vaccines/ed/covid19/SHVA/20010.asp. Training includes general COVID-19 vaccine storage, handling, and transport information. The addendum will be updated as COVID-19 vaccine products are approved. Fact sheets for storage and handling are also available at https://www.cdc.gov/vaccines/covid-19/ to use as job aids for each COVID-19 vaccine. Additional information related to storage, handling, shipping, package, and transport are available below:
a. Pfizer-BioNTech COVID-19 Vaccine: https://www.cvdvaccine-us.com/product-storage-
and-dry-ice b. Moderna COVID-19 Vaccine: https://www.modernatx.com/covid19vaccine- eua/providers/storage-handling
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COVID-19 Vaccine Administration: Vaccine Preparation and Administration training are
available at the following links. Trainings include vaccine indications, vaccine preparation, vaccine administration, and documentation for COVID-19. a. Pfizer-BioNTech COVID-19 Vaccine Training Links: i. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html ii. https://www.cvdvaccine-us.com/dosing-and-administration iii. For additional information: https://www.pfizer.com/ b. Moderna COVID-19 Vaccine Training Links: iv. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html v. https://www.modernatx.com/covid19vaccine-eua/providers/dosing- administration vi. For additional information: https://www.modernatx.com/
Emergency Use Authorization information with COVID-19 vaccine indications,
contraindications/precautions, vaccine preparation, vaccine administration, and documentation are available at the following links: a. Pfizer-BioNTech COVID-19 Vaccine: https://www.cdc.gov/vaccines/covid-19/info-by- product/pfizer/index.html b. Moderna COVID-19 Vaccine: https://www.cdc.gov/vaccines/covid-19/info-by- product/moderna/
3. Interim Guidance for Immunization Services During the COVID-19 Pandemic: The CDC developed a website for providers to access resources and FAQ document(s) to use as job aids and training material: https://www.cdc.gov/vaccines/pandemic-guidance/index.html
Interim CDC Clinical Considerations regarding COVID-19 vaccination includes, but is not limited to: • Vaccinations of patients with underlying medical conditions • Vaccination during pregnancy or breast-feeding • Vaccination of children/adolescents • Allergies These resources can be accessed at https://www.cdc.gov/vaccines/covid-19/info-by- product/clinical-considerations.html.
4. Documentation and Tracking of Provider Training: As part of the CDC COVID-19 Vaccination Program, each enrolled vaccination location will be required to submit training verification records for all providers covered under the organization as part of their Provider Agreement. Each COVID-19 provider will be required to sign the appropriate provider agreements and undergo training on how to utilize GRITS(IIS) functionalities, monitor and manage vaccine inventory within GRITS, and submit data. Training is available at https://www.gritstest.state.ga.us/docs/ManageOrders_20FEB_2014_Final_Copy.htm.
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5. Additional training and education materials for Healthcare Professionals and Jurisdiction can be accessed from the CDC website at https://www.cdc.gov/vaccines/covid-19/index.html.
DPH’s GIP and Emergency Preparedness and Response (EPR) began assessing vaccine administration capacity and vaccine provider interest in August 2020. Using Geographic Information Systems (GIS) vaccine administration data from GRITS, we will evaluate vaccine accessibility throughout the state. These maps will allow Georgia to assess current capacity and identify pockets of need across the state.
Data elements will include, but are not limited to:
1. Provider type 2. Populations served as stated in the provider profiles 3. Vaccine storage capabilities 4. Number of vaccines on hand 5. Doses of vaccines administered
All maps will be shared with our public health partners and others to be used for situational awareness purposes and assist with local vaccination efforts.
Section 7: COVID-19 Vaccine Allocation, Ordering, Distribution, and
Inventory Management The information provided in this section is based on current assumptions as provided by the CDC. This section will be reviewed, revised, or updated as the situation develops, and additional guidance and recommendations are shared.
COVID-19 Vaccine Allocation
When the COVID-19 vaccine first becomes available for allocation, GIP will utilize information collected from the COVID-19 Vaccine Pre-Enrollment Questionnaire (Appendix F). Data will be extracted and filtered to prioritize providers with high volumes of Phase 1: frontline workers/first responders (hospitals, EMS, etc.), long term care facilities (LTCs), and the capacity to vaccinate their staff, patients, and community. In partnership with state public health’s Office of Emergency Preparedness and Response, GIP plans to utilize Geographic Information System (GIS) mapping to assess vaccine accessibility throughout the state. Provider type and populations served stated in the provider profiles
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will be added factors to determining allocation prioritization. As more COVID-19 vaccine becomes available, GIP will utilize the same method for allocating to providers of Phase 2: other essential workers and other vulnerable populations, and Phase 3: General Public (which would include children and other non-vulnerable adults).
COVID-19 Vaccine Cold Chain Management
A key component in GIP’s plan to incorporate COVID-19 vaccine allotments is by assuring providers can maintain cold chain capabilities. This is accomplished by collecting providers’ documentation of completed vaccine storage and handling training required during the enrollment process and verifying proper working equipment for vaccine storage during physical and virtual site visits.
GIP will adhere to vaccine manufacturer, ACIP, and CDC guidance regarding proper storage and handling of the COVID-19 vaccine and share this information with COVID-19 providers once this guidance has been updated and made available.
COVID-19 Vaccine Ordering
GIP will initially mass upload provider information into the CDC Vaccine Tracking System (VTrckS) utilizing information collected from the GRITS and COVID-19 Provider Profiles. Mass uploads will continue as deemed necessary, and staff will individually upload/update a single provider’s information in VTrckS on a case-by-case basis. Allocations will be processed via VTrckS EXIS Provider Orders (Sales Orders) Interface, similarly to how other seasonal Special Circumstance orders are processed, such as influenza. A .csv file indicating information of providers to receive the COVID-19 vaccine will be uploaded.
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Transfer or Redistribution of Vaccine
Providers should not transfer or redistribute COVID-19 vaccine without notifying GIP. Providers will have an Immunization Regional Consultant assigned to their site who will coordinate with GIP.
Vaccine Wastage and Inventory Levels
Tracking COVID-19 vaccine wastage/spoilage and inventory levels will be recorded through GRITS. Additional information on avoiding vaccine waste can be found in DPH’s “COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy .”
Section 8: COVID-19 Vaccine Storage and Handling
Cold chain storage and handling requirements for each vaccine product will vary from refrigerated (2° to 8° C) to frozen (-20°C) to ultra-cold (-60° to -80°C) temperatures, and ongoing stability testing may impact these requirements. Vaccines must be stored appropriately from the time they are manufactured until they are administered to a patient. Excessive heat or cold may reduce vaccine potency, thereby increasing the risk that recipients will not be protected against vaccine-preventable diseases. Complying with state and federal laws and regulations relating to the storage, security, and distribution of vaccines is a requirement to assure quality pharmaceutical services consistent with attaining high pharmaceutical integrity standards for all recipients of COVID-19 Vaccine. Failure to maintain vaccine product integrity can result in patients inadvertently receiving a compromised vaccine, facilities unable to access or replace limited vaccine inventory, re-vaccination having to occur for patients, and loss of patient confidence.
The U.S. Pharmacopeia (USP) Chapter <659> "Packaging and Storage Requirements" provides examples of different temperature storage conditions. The following definitions have been provided and have been verified in the latest release of the USP <659> Chapter: • FROZEN- Any temperature at -20°C (-5 degrees Fahrenheit). A freezer is a cold storage unit in which the temperature is maintained at −25°C and −10°C (−13°F and 14° F). • Cold: Any temperature not exceeding 8°C. A refrigerator is a cold storage unit in which the temperature is maintained between 2°C and 8°C (36 to 46 °F). • Cool: Any temperature between 8°C and 15°C (46°F and 59 °F) • Controlled room temperature: The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20°C-25°C(68°F-77 °F). • Warm: Any temperature between 30°C and 40°C (86° and 104 °F). • Excessive Heat: Any temperature above 40°C (104 °F).
U.S. Pharmacopeial Convention. USP General Chapter <659> Packaging and Storage Requirements. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/659_rb_notice_english.pdf
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The CDC COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations describes ultra- cold vaccine storage temperature as around -60°C to -80°C.
Individual Provider Locations Responsibilities
1. COVID vaccine locations should ASSIGN responsibility for handling vaccines to a primary and secondary point of contact. 2. CHECK vaccine shipments immediately upon arrival. 3. STORE vaccines in a pharmaceutical-grade, commercial-grade, stand-alone unit, or ultra-cold storage unit. More information on proper COVID-19 vaccine storage can be found in the CDC’s Storage and Handling Toolkit: https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html The receiving facility will be responsible for tracking the vaccine product and maintaining cold- chain documentation for any verification purposes. The facility will agree to provide digital data logger files and temperature logs upon request from the Office of Immunization within 1 business day of the request. 4. RECORD temperatures at the beginning of the day using a digital data logger with a current certificate of calibration. Refrigerator temperatures should remain between 36- 46° Fahrenheit and 2°-8° Celsius. Freezer temperatures should remain between 5° or colder Fahrenheit and -15° or colder Celsius. Ultra-cold (-60° to -80°C): Temperature excursions outside of the required range should be reported to [email protected] within 24 hours. All providers are required to have at least one backup digital data logger in the event the primary data logger malfunctions. 5. ROTATE vaccine stock to assure short-dated vaccines are administered before the expiration date. 6. REPORT short-dated vaccines 30 days before expiration to GIP. 7. RETURN a. Thermal Shippers i. Pfizer-BioNTech: https://contlogo.s3.eu-central- 1.amazonaws.com/Pfizer/Thermal%20Shipper%20Return%20Guidance.pdf 1. Video: https://www.cvdvaccine-us.com/product-storage-and-dry-ice b. Wastage / Expired vaccine c. DPH is awaiting further Federal guidance regarding return processes and procedures. 8. MAINTAIN a completed Routine and Emergency Vaccine Handling Plan in an accessible location in the event of refrigerator/freezer malfunctions, natural disasters, etc. This plan should be reviewed monthly and updated as often as needed.
Satellite, Temporary, or Off-Site Settings
To increase equitable vaccine access to the COVID-19 vaccine, Providers may conduct satellite, temporary, or off-site clinics in collaboration with community stakeholders. Providers involved with off- 31 | P a g e GEORGIA INTERIM COVID-19 VACCINATION PLAN
site locations should assure that the vaccine cold-chain is maintained and follow COVID vaccine storage and handling practices.
Resources for off-site vaccination clinics that should be reviewed include but are not limited to the following:
1. CDC’s Guidance for Planning Vaccination Clinics Held at Satellite, Temporary, or Off-Site Location https://www.cdc.gov/vaccines/hcp/admin/mass-clinic-activities/index.html 2. CDC’s COVID-19 Addendum to CDC’s Vaccine Storage and Handling Toolkit https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html 3. CDC’s Guidance for Vaccination During a Pandemic https://www.cdc.gov/vaccines/pandemic-guidance/index.html
Additional considerations for off-site vaccination clinics
• The number of vaccines transported to an off-site or mass vaccination clinic should be based on the anticipated number of individuals to be served. • Vaccines may be transported—not shipped—to a clinic site using vaccine transportation procedures outlined in CDC’s Vaccine Storage and Handling Toolkit. Procedures include transporting vaccines to and from the site at appropriate temperatures and using appropriate equipment, as well as monitoring and documenting temperatures using a digital data logger with a probe in buffered material. • Upon arrival at the clinic site, store vaccines correctly to maintain appropriate temperature throughout the clinic day. Maintaining temperatures includes reviewing temperatures every hour using a digital data logger with a digital display and a probe in a buffered material. At the end of the clinic day, the temperature data must be downloaded from the data logger and printed out. Make sure to document the date, location where the clinic was conducted, start time of transportation of vaccines, and end time of transportation of vaccines. • If vaccines are exposed to out of range temperatures at any time, vaccines are to be labeled “do not use” until steps are taken to assure vaccines are viable. Providers must follow the steps located in the vaccine incident report (https://www.gritstest.state.ga.us/docs/Blank_Vaccine_Incident_Report_Rev_09132017.pdf) and follow up with the designated manufacturers. Even if vaccines are deemed viable, you are required to keep all documentation related to the incident • Place a data logger in each portable storage unit containing an off-site vaccine. • Monitor the temperature in each portable storage unit every hour from the time it is placed in the cooler(s) until it is returned to the refrigerator. There is an hourly temperature log for this purpose. Download the data logger at the end of the off-site clinic and print a copy of the report.
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Section 9: COVID-19 Vaccine Administration Documentation and
Reporting DPH will use the Georgia Registry of Immunization Transactions and Services (GRITS) to collect COVID-19 vaccine doses administered data from providers. GRITS is an Internet-based IIS operated by the GIP. GRITS was developed in 2003 to comply with Georgia Law (OCGA 32 12 3.1) as a birth to death registry. GRITS Enables providers to determine whether patients are due or overdue for an immunization; clarifies immunization schedules and emerging vaccine combinations; and manages vaccine inventory.
Reporting using IZ Gateway Connect
Once it becomes available, GRITS plans to participate in the ‘Connect’ component of IZ Gateway and send COVID-19 related data, in real-time or scheduled upload, through an HL7 exchange. In the intervening time, the COVID-19 Vaccination Reporting Specifications and Submission (CVRS) will be used to report COVID records to the CDC. Manual uploads of the CVRS will be made directly to the Data Clearinghouse daily.
Through the online Pandemic Enrollment feature in GRITS, each COVID-19 provider must complete and sign the designated provider agreement. Proof of online training (CDC's You Call the Shots - Storage and Handling Module, CDC's COVID-19 training module, and GRITS Manage Orders Online Training) is monitored through review of certificates documenting completed training, which are uploaded to GRITS. Training can be given to new GRITS users by Immunization Regional Consultants (IRCs) field staff in a train-the-trainer setting as deemed necessary. Written ‘walkthrough’ tutorials will also be available for distribution.
Providers will test all data exchange connections with an IIS analyst to assure smooth data submission. Once all training and testing have taken place, providers will be reminded that adherence to the binding agreements is pertinent. Consistent, timely reporting must be completed within 24 hours of administration.
In collaboration with Gainwell partners and Wisconsin Immunization Registry (WIR) Consortium members, GRITS is working to develop a mobile IIS app for out-of-office use. Users will be able to submit vaccine administration data records from off-site and temporary clinic settings by manual input. Records will either immediately be retained in the IIS or be uploaded upon returning to their office when outside the internet is not available.
Data Entry and Reporting Monitoring
Districts received GIA funds, and some districts plan to use these funds to hire additional vaccine administrators. . All vaccine administrators will follow data submission processes.
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GRITS will instruct each user how to monitor data submissions with the “Check Status” function, which allows providers to review a log of all data records sent through data exchange, including percentages of error within each completed submission. Review the monthly generated provider report card, which shows the target percentage of what GRITS expects to receive vs. the percentage of what is received, per data field.
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GIP program will utilize the IIS, GRITS, to enforce the use of the three following methods in conducting COVID-19 vaccine second dose reminders:
1. Encourage COVID-19 vaccine providers to have vaccine recipients place a reminder on their cell phone: GIP will encourage COVID-19 vaccine providers to complete the vaccination record cards that will be included in every ancillary kit. Once accurate vaccination record card information is documented (i.e., vaccine manufacturer, lot number, date of first dose administration, and second dose due date), the provider will be encouraged to ask recipients to take a photo of the vaccine record card. Providers should also encourage recipients to place a reminder for the 2nd dose due date in their smartphone calendar (when applicable). Providers should tell recipients to bring vaccination cards with them when they return for their second dose.
2. Encourage COVID-19 vaccine providers to utilize their internal systems for second dose reminders: Many pharmacies and healthcare organizations have a system for their patient notifications and reminders, some using functionality within their electronic health record (EHR). Providers will be encouraged to use automated patient phone calls, emails, and text- message based systems for second dose reminders.
3. DPH will contract with a reminder recall vendor: DPH, through the Vaccine Registration and Administration Solutation (VRAS), will send second dose reminders to all COVID-19 vaccine receipients who received their first dose through VRAS. VRAS will also send reminders to vaccine recipients who received their first dose elsewhere but have registered and scheduled their second dose through VRAS. GIP is aware of potential health plans assisting in notifying their enrollees about second doses based on filed COVID-19 vaccine claim information, and therefore providing additional redundancy for second dose reminder methods.
Section 11: COVID-19 Requirements for IISs or Other External Systems
Description of Vaccine Related Data Elements
In addition to the required data elements listed in the CDC IIS Data Requirements for COVID-19 Vaccine Administration (Administered at a location, Administered at location: type, Administration address: city, Administration address: county, Administration address: state, Administration address: street, Administration address: zip code, Administration date, CVX (Product), Dose Number, IIS Recipient ID, IIS Vaccination Event ID, Lot Number: Unit of Sale, MVX, Recipient address: county, Recipient address: city,
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Recipient address: state, Recipient address: street, Recipient address: zip code, Recipient date of birth, Recipient name, Recipient sex, Sending Organization, Vaccination Complete, Vaccine administering site, Vaccine expiration date, and Vaccine route of administration), GRITS is also able to collect race and ethnicity.
COVID Vaccine Dashboard - Link
Data Exchange and Reporting GRITS Capabilities
All GRITS users have the option of sending that data to the system electronically. GRITS accepts client/immunization files in either a batch flat file, batch HL7, or real-time HL7 (version 2.5.1) upload. Batch uploads are manual processes. Real-time interfacing is automated through WSDL web service or PHINMS connection. Most GRITS users utilize the interface functionality.
Server consolidation will take place during second quarter of 2021, which will move GRITS to a cloud- based environment. This will essentially give GRITS an unlimited amount of storage capacity.
GRITS Provider Access – Registration
Enrollment in the GRITS database is a requirement for all vaccinating providers in Georgia. Providers who are not currently registered may begin this process by initiating an enrollment request via the GRITS online enrollment application (add link/web address). Onboarding registration can be handled within 24hrs or less. Registration includes gaining login credentials, scheduling training, and ascertaining needed functionalities (e.g., VFC enrollment, electronic data exchange, etc.).
Loss of System or Internet Connectivity
DPH continues to explore options to assure backup solutions are in place in the event system or internet connectivity issues occur. Discussions have included possible collaborations with other jurisdictions to develop a viable system-based solution, financially supported through a collective effort.
Data Quality Monitoring
GRITS will develop the GRITS Provider Report Card to highlight the completeness of an organization’s electronic reporting fields. The report card provides a visual of the target percentage of what GRITS expects to receive vs. the percentage of what is received, per data field. Currently, the report is automatically generated for each health department monthly. COVID-19 providers not already included as part of another vaccine program will be added to that list.
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Section 12: COVID-19 Vaccination Program Communication
Communication plans have been established within the State DPH Crisis and Emergency Risk Communication (CERC) plan. The plan has been vetted, updated, and approved for use in emergencies with an all-hazards approach. Spokespersons for news conferences and media inquiries will be selected from within the GIP, and DPH leadership may include, but are not limited to, the GIP Director, GIP Subject Matter Experts, and DPH leads, including the Commissioner, the Health Protection Director, and the Communications Director. Every Communications endeavor outlined in this plan will be conducted with considerations to maximize health equity, providing information and vaccine services to those in the greatest need for the information and services.
The state DPH Division of Communications will lead the coordination of communication efforts about vaccine development and availability.
• The public will receive this information from the state DPH website, media reports, and additional marketing campaigns as funding allows. Information will be promoted through social media and updated as more information and resources become available from the CDC. The state DPH website includes an icon specifically for the use of public COVID-19 questions and concerns. A statewide COVID-19 hotline number is listed on the website and promoted elsewhere to address public questions and concerns. The public also can have questions and concerns addressed by phone, e-mail, or in-person, where possible, at all state and local DPH offices. • Healthcare providers will be informed through regular communications, as established with the Regional Coordinating Hospital system, and directly through DPH Communications' constant contact list-serve. • Partner agencies’ informational updates on vaccine development and availability will be coordinated through the Joint Information Center (JIC) operations and redundantly through communications with the 18 Public Health districts and their communicators.
The DPH Division of Communications has and will continue to update media contacts with various media outlets, including tv, radio, newspaper, and on-line news services locally and statewide throughout Georgia.
Vaccine public education will be coordinated through the GIP and DPH Division of Communications. Key audiences have been and will continue to be, identified by the GIP and the state DPH Division of Communications. Key audiences will receive targeted messages effectively and timely as set forth by the three anticipated phases of vaccine availability. Such key audiences will include but are not limited to employers, essential workers, those with limited access to vaccine services, and other major stakeholders in the healthcare system.
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Plain language will be used in social media messages, infographics, news releases, and other methods of promoting Public Health messages throughout Georgia as part of a coordinated effort to assure a consistent approach to COVID-19 vaccination communication. Further educational outreach will be conducted through targeted marketing campaigns as funding allows. Outreach will be accomplished in phases, including ‘Limited’ vaccine supply, ‘Increased Availability,’ and ‘Widely Available.’ Communication plans for the phases of vaccine availability are outlined in the state DPH CERC plan's timed response actions.
Clear, concise, and consistent communication activities, taking into account social, economic, and demographical determinants, will be conducted to assure the highest possible public confidence in the efficacy of the COVID-19 vaccine. Communication will include information on what is known and what is still being researched transparently. Messaging to assure the highest public health and safety related to COVID-19 vaccination will follow the same pattern established through the first nine months of 2020. Messaging includes frequent updates to the website and posted information in the virtual JIC housed within WebEOC. Messaging may also include further development of infographics, fact sheets, and other communication tools available to all DPH and external partners.
The GIP and DPH Division of Communications will continue collaborative efforts to identify talking points and key considerations associated with COVID-19 vaccination endeavors. Efforts include identifying populations of focus who are at the greatest risk of negative outcomes related to contracting COVID-19. The DPH Division of Communications will coordinate with local Public Health districts to identify the at- risk populations and determine the most effective mediums to use in messaging to those key audiences. Coordination may include but is not limited to language consideration, spokesperson selection, and other facets of effective messaging. Plans are in place to expand such considerations externally through the DPH led Joint Information Center (JIC). The JIC was established on March 2, 2020. As of September 26, 2020, it includes 148 members from more than 50 local, state, and federal government and stakeholder agencies partnered for Communications in response to COVID-19 in Georgia.
The DPH Emergency Preparedness Limited English Proficiency/Sensory Impairment database identifies languages and communication means within each of the 18 health districts. Additionally, the database provides contact information on Phased levels for interpretation, translation, and other resource services. Additionally, local Public Health offices can provide resource capacity in the form of trusted community leaders and other partnerships to effectively reach all audiences.
Vaccine administration locations will be posted on the state DPH website in a timely, accurate fashion and on the 18 Public Health districts' digital properties within Georgia. Locations will be shared with the public, media, and partners to reach the largest audience, focusing on making the information available to those targeted audiences that are the most vulnerable, thereby in the greatest need of receiving a vaccination. Similar strategies were developed and improved statewide to promote COVID-19 Specimen Point of Collection (SPOC) locations. The uptake of the COVID-19 vaccine will be tracked and monitored
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by GIP and information shared internally. External information may be shared through Communications as deemed necessary by the Division of Communications, GIP, and DPH leadership.
Section 13: Regulatory Considerations for COVID-19 Vaccination
Currently, initial COVID-19 vaccines have been authorized under a EUA issued by the FDA. COVID-19 vaccines may also be approved as licensed vaccines. DPH will continue to monitor this development and share the below plans with COVID-19 providers to assure preparedness under both scenarios. To provide proper vaccine administration and patient care, DPH will observe ACIP COVID-19 vaccine recommendations.
Scenario 1: Emergency Use Authorization (EUA)
The EUA authority allows FDA to authorize either (a) the use of an unapproved medical product (which includes vaccine) or (b) the unapproved use of an approved medical product during an emergency based on certain criteria. If the COVID-19 vaccine is released under a EUA, the EUA will provide specific guidance regarding how the COVID-19 vaccine should be used and any conditions that must be met to use the vaccine. The “condition of authorization” will be discussed and confirmed between the FDA and CDC. Conditions are expected to cover distribution requirements, reporting requirements, and safety monitoring requirements. EUAs are authorized for a specific period and will expire at the end of the defined period. While the COVID-19 vaccine remains under and EUA, COVID-19 providers will be required to provide a copy of the EUA fact sheet to each patient, parent, or guardian before the vaccine is administered.
Scenario 2: Licensed Vaccine
VISs are required after a vaccine has been licensed and added to the Vaccine Injury Table. Planning for developing VIS for the COVID-19 vaccine is still being discussed at the federal level. Once made available, COVID-19 providers will be required to provide a copy of the VIS to each patient, parent, or guardian before the vaccine is administered. DPH will continue to monitor this situation and update this plan as additional guidance is received.
Section 14: COVID-19 Vaccine Safety Monitoring
Providers authorized to administer vaccines are required by federal law to report to VAERS any adverse event following immunization, including a vaccine administration error. The CDC Vaccine Adverse Event Reporting System (VAERS) policy is located in the GIP Manual (Chapter 4) accessible on the DPH website https://dph.georgia.gov/immunization-section/immunization-publications. GIP will include VAERS reporting procedure job aids and website information in provider training materials and resources. CDC has developed a website and an Interim Guidance for Providing Vaccinations Safely During A Pandemic, which will also be shared with providers. GIP will share all CDC COVID-19 safety information on the DPH website. 39 | P a g e GEORGIA INTERIM COVID-19 VACCINATION PLAN
V-Safe V-Safe is a new voluntary, smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins for COVID-19 vaccine recipients. V-safe allows participants to report any side effects after the COVID-19 vaccination to CDC in almost real-time. It also gives them a convenient reminder to get their second COVID-19 vaccine dose if they need one. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html
National Healthcare Safety Network (NHSN)
An acute-care and long-term care facility monitoring system that will promote reporting to VAERS. The new COVID-19 vaccine safety surveillance systems and any additional information sources will be shared with providers as it becomes available. https://www.cdc.gov/nhsn/index.html
Section 15: COVID-19 Vaccination Program Monitoring
The GIP will assume responsibility for continuous monitoring for vaccine-related situational awareness throughout COVID-19 vaccination response activitiesGIP will review available CDC dashboards (e.g., Weekly Flu Vaccination Dashboard and COVID-19 Vaccination Response Dashboard), as additional monitoring tools. GIP will work with the Pandemic Vaccine Planning Team to share identified issues and update this plan to address these issues. GIP will use the COVID-19 vaccine e-mail to provide an open- communication stream between COVID-19 vaccine providers and our office.
Through the Administrative Order, DPH has ordered COVID-19 Program Providers to comply with DPH’s Policy “COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy.” To evidence acceptance of the requirements of the Policy, each Provider must sign an “Acceptance of COVID-19 Vaccine Program Provider Accountability and Waste Avoidance Policy.” DPH has also implemented a “COVID-19 Vaccine Program Provider Fraud Policy.” Together these memorialize DPH’s monitoring of the COVID-19 Vaccination Program and the penalties and corrective action that can be required for identified fraud, abuse and/or vaccine waste.
Vaccine Usage and Accountability Administrative Order
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Appendix Appendix A: Acronyms Appendix B: Core COVID-19 Vaccine Planning Team and List of State and Local Partners Appendix C: Georgia Priority Populations Vaccine Allocation Matrix Appendix D: Critical Populations Data Appendix E: Population Group Worksheet Appendix F: COVID-19 Vaccine Pre-Enrollment Questionnaire Appendix G: Georgia COVID-19 Vaccine Planning Frequently Asked Questions
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Appendix A: Acronyms
ACIP: Advisory Committee on Immunization Practices
CDC: Center for Disease Control and Prevention DPH: Georgia Department of Public Health EUA: Emergency Use Authorization FDA: Federal Drug Administration GEMA: Georgia Emergency Management Agency GIP: Georgia Immunization Program GRITS: Georgia Registry for Immunization Transactions and Services IIS: Immunization Information System (GRITS in Georgia) MCM: Medical Countermeasures MVC: Mass Vaccination Clinic POD: Point of Distribution SNS: Strategic National Stockpile SOP: Standard Operating Procedures VAERS: Vaccine Adverse Event Reporting System VIS: Vaccine Information Statements VTrckS: CDC Vaccine Tracking System NHSN: National Healthcare Safety Network WIR: Wisconsin Immunizations Registry
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Appendix B: Core COVID-19 Vaccine Planning Team and List of State and Local Partners Georgia Vaccine Task Force
• Office of the Governor
• Office of Insurance and Safety Fire Commissioner • Georgia Department of Public Health • Georgia Emergency Management and Homeland Security Agency
Georgia DPH Core COVID-19 Vaccine Planning Team
• Division Epidemiology
• Division of Health Protection
o Emergency Preparedness Program o Office of Emergency Medical Services o • Division of Medical and Clinical Services o Immunization Program o Office of Nursing o Office of Pharmacy
• Office of General Counsel
State and Local Partners
• Georgia Public Health Districts (18)
• Georgia Chapter of American Academy of Pediatrics • Georgia Hospital Association • Georgia Health Care Association • University System of Georgia • Emory University • Morehouse School of Medicine • Georgia Primary Care Association • Georgia Pharmacy Association • Georgia Department of Community Health • Georgia Department of Behavioral Health Disorders and Disabilities • Georgia Alliant Quality – Quality Improvement for Alliant Health Solutions
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Appendix C: Georgia Priority Population Vaccine Allocation Phases
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Adults with intellectual and developmental disabilities are defined by:
Intellectual Disability is a disability characterized by significant limitations in both intellectual functioning and in adaptive behavior, which covers many everyday social and practical skills. This disability originates before the age of 22.
A developmental disability is a physical or mental impairment that happens before the age of 22, is expected to last a lifetime, and impacts at least three activities of daily living. Activities of daily living include self-care; receptive and expressive language; learning; mobility; self-direction; capacity for independent living; and economic self-sufficiency.
Children with Complex Medical Conditions or who are at high risk for COVID complications include: • Malignancies requiring active treatment • Immunocompromised state (weakened immune system) including organ transplant (bone marrow or solid organ) within 2 years • Critical congenital heart disease • Asthma (moderate to severe) • Sickle cell disease • Diabetes • Obesity (BMI >95%) • Cystic fibrosis • Significant neurologic injury or condition (e.g. hypoxic ischemic encephalopathy, traumatic brain injury, congenital anomaly, acute flaccid myelitis) with functional/developmental impairment (e.g. cerebral palsy, developmental disability, prematurity, mitochondrial disease) • Technology dependence (e.g. BiPAP, trach)
Appendix D: Estimating Critical Populations in Georgia
Healthcare Personnel Subpopulation Identify Estimate Data Sources
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Practicing Physicians Georgia Board of Health Care Workforce 22,471 • https://healthcareworkforce.georgia.gov/document/publication
(https://healthcareworkforce.georgia.gov/) /distribution-physicians-practice-settings-2015/download • https://healthcareworkforce.georgia.gov/main-publications- reports/data-publications/counties-without-pcps • https://healthcareworkforce.georgia.gov/physician-workforce- data Practicing Physician Georgia Board of Health Care Workforce 3,810 • https://healthcareworkforce.georgia.gov/physician-workforce- Assistants (https://healthcareworkforce.georgia.gov/) data • https://healthcareworkforce.georgia.gov/physician-assistant- workforce-report Practicing Nurses Georgia Board of Health Care Workforce 141,117 • https://healthcareworkforce.georgia.gov/physician-workforce- (https://healthcareworkforce.georgia.gov/) data Psychiatrists Georgia Board of Health Care Workforce 1,097 • https://healthcareworkforce.georgia.gov/document/publication (https://healthcareworkforce.georgia.gov/) /psychiatry-distribution-georgia-2015/download Dentists Georgia Board of Health Care Workforce 5,143 • https://healthcareworkforce.georgia.gov/dentistry-workforce- (https://healthcareworkforce.georgia.gov/) reports List of Providers Georgia Department of Community Health 60,000 • https://dch.georgia.gov/providers/provider-directory (Physicians, (https://dch.georgia.gov/) providers listed (some are facility- Pharmacies, Nursing level) Services, Behavioral Health…etc.) Directory of Georgia Department of Community Health TBD • https://gadch.mylicense.com/verification/Search.aspx Pharmacists (https://dch.georgia.gov/) Critical Infrastructure Workers Subpopulation Identify Estimate Data Source Law Enforcement US Census Bureau Annual Survey of Public 2,706 https://www.census.gov/data/datasets/2019/econ/apes/annual- (police) Employment & Payroll apes.html 15,689 (https://www.census.gov) (corrections) First Responders
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Public Safety Education U.S. Census Bureau Annual Survey of Public 105,442 • https://www.census.gov/data/datasets/2019/econ/apes/annual Employment & Payroll -apes.html (https://www.census.gov) Food & Agriculture Energy Sector Water & Wastewater Transportation & US Census Bureau Annual Survey of Public 3,828 https://www.census.gov/data/datasets/2019/econ/apes/annual- logistics Employment & Payroll (Highways) apes.html (https://www.census.gov) Public Works & Infrastructure Long-term Care Facilities Subpopulation Identify Estimate Data Source Georgia Department of Community Health • https://dch.georgia.gov/announcement/2020-09-22/long-term- (https://dch.georgia.gov/) care-facility-covid-19-report Center for Medicaid and Medicare Services ~27,000 • https://data.cms.gov/Special-Programs-Initiatives-COVID-19- (https://data.cms.gov) Nursing-Home/COVID-19-Nursing-Home-Dataset/s2uc-8wxp Kaiser Family Foundation 22,894 • https://www.kff.org/other/state-indicator/number-of-nursing- (https://www.kff.org/) facility- residents/?activeTab=map¤tTimeframe=0&selectedDistri butions=number-of-nursing-facility- residents&sortModel=%7B%22colId%22:%22Location%22,%22so rt%22:%22asc%22%7D Other Vulnerable Populations Subpopulation Identify Estimate Data Source People 65-years of Georgia Online Analytical Statistical 1,516,954 • https://oasis.state.ga.us/oasis/webquery/qryPopulation.aspx age and older Information System (https://oasis.state.ga.us) Homeless Population 47 | P a g e GEORGIA INTERIM COVID-19 VACCINATION PLAN
Refugees Migrant Workers
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Answer: A mass vaccination pandemic site is a site willing to serve their patients following normal business practices, as well as all members of the community during scheduled mass vaccination events.
2. How much will the vaccine cost?
Answer: There is no charge for the COVID-19 vaccine. The vaccines have been paid for with federal funds at no cost to the patient nor provider, which means that no one may be charged a fee for the vaccine itself.
3. If given to providers free of charge, can we charge patients an administration fee?
Answer: Providers may bill a patient’s insurance for costs associated with the administration of COVID vaccine to administer each dose. However, providers are not allowed to bill the patient directly.
4. Are we agreeing to vaccinate the general population, not just our clinic’s patients?
Answer: Providers can either be a "mass" vaccination pandemic site or a "private" pandemic vaccination site: a. If your clinic has the staff/capacity to serve your patients following normal business practices, as well as, members of your community during scheduled mass vaccination events, you will be designated as a mass vaccination pandemic site and eligible to receive vaccine supply to serve your patient population and members of your community. b. If your clinic only has the staff/capacity to serve your current patient population, you will be designated as a private pandemic vaccination site, and only receive vaccine supply to serve your patient population.
5. In what ways may hospitals, urgent care facilities, emergency medical services, and other facilities assist in the state’s vaccination efforts?
Answer: You have three options. You can either be a closed vaccine point of dispensing (POD) site, “mass" vaccination pandemic site, or a "private" pandemic vaccination site: a. If your facility only serves your staff and your admitted patient population within current phase, you will be designated as a closed POD. These facilities will work with their local Public Health Emergency Preparedness team for more information on
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becoming a closed POD. Providers cannot vaccinate individuals that fall out side the current approved phases as a closed POD. b. If your facility has the staff/capacity to serve your in-patients and out-patients following normal business practices, as well as, members of your community during scheduled mass vaccination events, you will be designated as a mass vaccination pandemic site and eligible to receive vaccine supply to serve your patient population and members of your community. c. If your facility only has the staff/capacity to serve your current patient population, you will be designated as a private pandemic vaccination site, and only receive vaccine supply to serve your patient population.
6. If we are agreeing to vaccinate the population, what hours are required from us? Would this be after our normal business hours? During business hours? Are weekends required?
Answer: Your clinic will be responsible for setting your mass vaccination clinic hours and reporting these hours to the Georgia Immunization Program. Clinics should account for the needs of your patient population and the community when establishing hours.
7. What compensation will our employees receive for vaccinating the population?
Answer: While vaccine and ancillary supplies will be provided to participating providers at no cost to the provider or recipients, funding is not available to provide compensation for participating sites or your employees. Participation is voluntary.
8. Will supplies such as needles, syringes, Band-Aids, alcohol preps, and gauze be provided as they were when the H1N1 vaccine was released?
Answer: Yes, providers will receive two different types of kits based on the vaccine supply received: a. Administration Kits with needles, syringes, alcohol prep pads, facemasks, and face shields (all vaccines). b. Mixing Kits with needles/mixing syringes to support vaccines that require field mixing (as applicable). c. Sharps containers will not be supplied.
9. For pediatric clinical sites, does the vaccine logistics include administering to adults, as well?
Answer: Yes. If your clinic decides to be a mass vaccination pandemic site, you are agreeing to serve your patients and members of your community, including adults.
10. For adult clinical sites, does the vaccine logistics include administering to children, as well? 50 | P a g e GEORGIA INTERIM COVID-19 VACCINATION PLAN
Answer: Yes. If your clinic decides to be a mass vaccination pandemic site, you are agreeing to serve your patients and members of your community, including children if the vaccine is approved by FDA for children.
11. Please explain how the program will roll out (logistics/planning type questions).
Answer: Vaccines will be released in a phased approach:
a. Phase 1: Vaccines will be available in limited quantities and provided to enrolled providers to assure vaccination of our Phase 1 targeted populations. b. Phase 2: Vaccine will be available in higher quantities and provided to pandemic vaccination providers who agree to serve as mass pandemic vaccination sites and other providers who serve members of the Phase 2 targeted populations c. Phase 3: Vaccine will be widely available and provided to providers mentioned above, as well as providers who agreed to serve as a pandemic vaccine site. Vaccines will be available for general administration to the general public based on vaccine recommendations.
12. We only want to provide to our patients, if we do not participate, will we still have the vaccine to administer?
Answer: If you only want to provide the vaccine to your patients, your clinic will need to sign up as a "private" pandemic vaccination site. We will ship the vaccine to your site once available and based on the phases outlined above.
13. Will funding be provided to purchase vaccine storage units and other supplies for providers?
Answer: There is limited funding to support vaccine storage units and other supplies for district and county public health sites. However, private facilities will need to support their cold chain requirements.
14. Will there be a single-dose vaccine, or will a second dose be required at some point after the 1st dose?
Answer: Vaccine is currently available as a 2 dose series. However, as new vaccines are developed and approved, vaccines may be available as both single-dose and 2 dose series, to include different brands and preparations with varying administration schedules.
15. What procedures will be followed for the administration of the vaccine for children?
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Answer: Information for the pediatric vaccine(s) is currently not available. We will share that information once received.
16. Will the vaccine(s) go through the same FDA process as other vaccines, or have special considerations been made given due to the pandemic?
Answer: The FDA process has been streamlined for Project Warp Speed (The Federal COVID-19 vaccine development project). The vaccines will undergo a review and approval process with FDA, but the exact form of approval is still pending, e.g., standard approval, emergency use authorization (EUA), etc.
17. Will ancillary supplies be provided with the vaccine to local health departments?
Answer: Yes, ancillary supplies will be provided with the vaccines. Please refer to the response to Question 6 for more detailed information regarding anticipated supply kits.
18. Will contractual agency staffing be able to assist in giving the vaccine?
Answer: Yes, if it is within their scope of practice to administer vaccines and within the scope of the DPH contract.
19. Who will give the injections at the closed POD locations?
Answer: Staff within the closed POD may administer a vaccine based on their clinical scope.
20. After reviewing the slide (trying to read between the lines), it appears that we may have two or more different manufacturers of vaccines, and if you start with one, the second dose must be the same brand. When shipping out the vaccine to the closed pods will someone make sure that they get the same brand each time they receive a shipment?
Answer: The allocations of vaccines will go through the DPH Office of Immunization and the CDC Distribution site. However, inventory management at the vaccination clinic site will play an important role in tracking this information and assuring the vaccine is available to complete the patient vaccine series. Staff should also use GRITS as a resource for confirming previous doses administered if the first dose was received at an alternate location.
21. What kind of paperwork will closed PODs complete, and how will the information get into GRITS?
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Answer: Closed PODs should use electronic medical records and/or GRITS for data collection/submission. If a closed POD does not have access to GRITS, or their EMR does not interface with GRITS, please reach out to the Office of Immunization to work on a solution.
22. How will you make sure that closed PODs have digital data loggers and Koolatrons in place with a contact person to receive the vaccine?
Answer: Determining whether a location can support the cold chain requirements for the vaccine and having designated staff to oversee vaccine management practices within each location is part of the enrollment process for becoming a provider. These items must be confirmed before marking a site as an active provider.
23. Does the vaccine follow the same regulations for temperature monitoring as other vaccines the state provides?
Answer: Yes. Temperature monitoring requirements will be the same as other vaccines.
24. Are you developing just in time training with regards to the administration of the vaccine as well as storage and handling?
Answer: Yes. Just in Time Training will be developed and shared with all vaccine providers.
25. Will vaccines be shipped to jails/ correctional institutions once the critical workforce has been vaccinated?
Answer: No. Federal correctional institutions will receive guidance and vaccine directly from the CDC. If local public health would like to vaccinate at their county or local jails and are trying to develop a relationship, we have contacts with the 'Sheriff's Association to help establish the relationship, if needed. Additionally, the state vaccination planning team will work with the Georgia Department of Corrections to address their vaccination needs.
26. Should DPH Health Districts plan for the distribution of vaccines to EMS?
Answer: Vaccines will be shipped to EMS sites directly from CDC's distribution center if they are actively enrolled as pandemic vaccine providers with the Office of Immunizations. If a district would like to support the storage of the vaccine to help its EMS partners, they may do so but need to assure they have the capability/capacity to do so.
27. Do we need to plan for the cold chain for pre-filled syringes?
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Answer: This is a possibility, so please prepare for all presentation types (multidose vials, single-dose vials, and pre-filled syringes).
28. Can a closed POD plan for vaccination of targeted partners? For example, EMS vaccinating other first responders in the county.
Answer: Yes, they should be able to administer the vaccine to other public safety agencies. Please make sure the EMS service provider consults their medical director for approval and coordinate with the DPH Office of EMS.
29. When will community engagement communication strategy documents be made available to begin education?
Answer: The CDC released guidance that includes communication strategies. The DPH COVID- 19 Planning Committee is working to develop a state plan that will include these strategies and provide a guide to vaccination partners once finalized.
30. How much education will be given to the public before vaccine administration?
Answer: Development and release of educational information will continue throughout this response. As we receive information from the CDC regarding education and guidance, we will work with DPH Communications, our state public health partners, and the districts to develop and implement appropriate education strategies.
31. Does the State know the cold chain requirements for each of the products ?
Answer: Please refer to the product insert as storage requirements will differ between vaccine brands: 1. Refrigerated: 2-8C 2. Frozen: -20C 3. Ultracold: -80C
32. If given "free," how will we know if someone goes to another source to get the vaccine and then chooses to come to our facility to receive an additional vaccine?
Answer: All vaccinations should be recorded in GRITS following administration. This will allow clinical staff to view the recipient’s record to determine vaccine history if this is suspected of an individual.
33. Can providers get assistance with expanding cold chain capacity?
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Answer: If it is a public health county/district-based provider, yes. Please contact the Office of Immunization for further guidance. If it is a private provider, they should procure their cold chain management.
34. How do we dispose of the expired vaccine?
Answer: Continue to provide a vaccine until it has reached its expiration date. If a vaccine expires, please document this appropriately and dispose of the expired vaccine following normal procedures for disposing biomedical waste. We will provide more information regarding expired vaccines following receipt. .
35. Where can I find information regarding liability immunity for covered persons during an emergency response event?
The Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID-19 provides liability immunity to covered persons. The third amendment to the declaration defines “covered persons”.
36. When will COVID-19 vaccine arrive in Georgia?
The first doses of COVID-19 vaccine arrived in Georgia in mid-December. Initial supply is limited and individuals receiving the vaccine will be prioritized based on risk of exposure and transmission.
37. Who should be vaccinated against COVID-19 infection?
The goal is for everyone to be able to easily get vaccinated against COVID-19 as soon as large enough quantities are available. Once vaccine is widely available, the plan is to have several thousand vaccination providers offering COVID-19 vaccines in doctors’ offices, retail pharmacies, hospitals, federally qualified health centers and county health departments.
38. Who will get vaccinated first?
The Georgia Department of Public Health followed the recommendations of the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) for prioritizing vaccination. Based on the risk of infection and transmission of COVID-19, and ethical concerns, ACIP has recommended that healthcare workers and residents of long- term care facilities be the highest priority groups to receive vaccine. Beginning on January 11, 2021, adults over the age of 65 and police and fire personnel were also made eligible to receive vaccine.
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39. When the vaccine becomes available to the public where can I go to receive it?
The vaccine will be available throughout Georgia. Once widely available to the general public you will be able to receive it from any location/provider that is enrolled as a COVID-19 vaccine provider – this includes private healthcare providers, health departments, pharmacies and hospitals.
40. What is ACIP?
The CDC Advisory Committee on Immunization Practices (ACIP) is a panel of medical and public health experts and medical ethicists who develop recommendations on the use of vaccines in the United States. The recommendations provide public health guidance for safe use of vaccines and related biological products.
41. What is an EUA?
In certain public health emergencies, FDA may issue an Emergency Use Authorization or EUA which allows a drug or vaccine to be used when there are no alternate treatments or vaccines available. The FDA may grant an EUA once studies have demonstrated the safety and effectiveness of a vaccine but before the manufacturer has submitted a full license application and/or before the FDA has completed its formal review of the license application.
