SARS-CoV-2/COVID-19 Mass Vaccination Planning Guide

Draft Planning Guide

Table of Contents

I. Introduction

In accordance with the state of Illinois Emergency Operations Plan (IEOP) and the Health and Medical Annex, this SARS-CoV-2/COVID-19 Mass Vaccination Guide was designed to provide a clear and comprehensive plan for the management and response to vaccination operations within the state. This guide provides direction for the Illinois Department of Public Health (IDPH), state and local response partner agencies, and other stakeholders involved in COVID-19 mass vaccine efforts.

This Guide is a product of the COVID-19 Mass Vaccination Planning Work Group. The COVID-19 Mass Vaccination Planning Work Group is composed of representatives of the various state stakeholder agencies with roles in public health emergency responses and those that serve organizations and individuals in the priority groups targeted for COVID-19 vaccine administration. See page 25 for a list of state and local agencies and organizations involved on the COVID-19 Mass Vaccination Planning Work Group.

This Guide is included as an Attachment to Annex 3.0 of the Illinois Pandemic Preparedness and Response Plan. The Illinois Mass Vaccination Annex provides a strategic overview of how pandemic vaccines will be allocated, distributed, and tracked in the State of Illinois. Local public health and health care entities are required to develop parallel tactical mass vaccination protocols to complement this state level plan.

In this Guide, pandemic vaccine administration planning has been updated using a two-tiered vaccine processing system, whereby standard operating procedures established by the IDPH Office of Health Protection’s Immunization Program will be utilized, in coordination with mass vaccination plans developed by the IDPH Office of Preparedness and Response’s Medical Countermeasures Program. Additionally, vaccine distribution, as outlined in the State of Illinois Strategic National Stockpile (SNS) Distribution Plan, supported by the Illinois Emergency Management Agency (IEMA), will be utilized as a backup/contingency plan to the planned should the method of direct shipping to the providers, not occur.

Recommendations and lessons learned from the 2009-10 H1N1 pandemic influenza response, the 2015 Centers for Disease Control and Prevention’s Pandemic Influenza Readiness Assessment (PIRA) for Illinois, the 2019 Crimson Contagion - Pandemic Exercise Series, and the 2020 SARS-CoV-2/ COVID-19 response, were used to inform updates to the Illinois Pandemic Preparedness and Response Plan and this mass vaccination planning guide. Lessons learned from H1N1 mass vaccination administration include: developing plans to continuously recruit and identify IDPH staff to “volunteer” (be reassigned) and train for a medical countermeasures event; better coordination with local public health jurisdictions on identifying and approving providers to administer the pandemic vaccine; developing a system for a more efficient ordering of the pandemic vaccine; developing a system for inventory management and tracking of vaccines administered; developing fair and equitable vaccine allocation processes; clear and concise communication with vaccine providers on vaccine ordering, distribution and allocation strategies developed; and ensuring all relevant media platforms are utilized for educating and communicating to all stakeholders on all components of the vaccine administration plan.

Additional changes include the decommissioning of the Illinois Immunization Promotion Center (IPC) and transitioning to the use of the Illinois Comprehensive Automated Immunization Registry Exchange (I-CARE Registry) as the online vaccination ordering system. I-CARE is currently in use for ordering and tracking of vaccines in the Vaccines for Children Program (VFC).

Section III Concept of Operations, J – Training provides an overview of suggested training and exercise topics for state and local COVID-19 mass vaccination administration planners. To ensure continuous quality improvement of the plan, lessons learned from these trainings and exercises will be used to further inform and update state and local plans in anticipation of the availability of the COVID-19 vaccine.

Vaccines will play a critical role in mitigating the SARS-CoV-2 pandemic and reducing the disease burden on the general population.

Due to the nature of the incident and vaccine availability, it may be necessary to identify priority groups based on the epidemiological data given at the time. Vaccine allocation may be necessary as vaccine becomes available. Allocation may be implemented to reduce the impact of the pandemic on the health of Illinois residents and minimize disruption to society and the economy.

Local public health, health care entities, and other vaccine providers are required to develop parallel tactical plans/protocols for administration to the general public and their critical infrastructure personnel. Likewise, the State of Illinois First Responder Prophylaxis Plan provides tactical protocols for distribution and administration of pandemic vaccine to state level first responders and critical infrastructure personnel.

Mission Goal – administer, potentially, two doses of a COVID-19 vaccine to 80% of the residents of Illinois according to CDC guidelines.

Specific Objectives:

  1. Ensure the safety of response personnel and citizens
  2. Prepare public health, health care, and other response partners to effectively manage all aspects of a statewide mass vaccination campaign
  3. Coordinate vaccine distribution to local providers
  4. Respond to requests for additional supplies, guidance, and information from external partners
  5. Mitigate COVID-19 disease propagation

II. COVID-19 Mass Vaccination Planning Assumptions

A. Vaccine distribution

  1. Limited COVID-19 vaccine doses may be available in November 2020
  2. COVID-19 vaccine supply will increase substantially in 2021, allowing regular shipments to states
  3. Vaccine providers will be required to legally enroll in the Illinois Comprehensive Automated Immunization Registry Exchange (I-CARE)
  4. Vaccine providers will be required to agree to follow CDC guidance on vaccine administration, storage, and handling by signing the CDC COVID-19 Vaccination Program Provider Agreement
  5. Vaccine providers will be allocated vaccine, as it becomes available, based on the overall jurisdiction’s population size and disease burden, while ensuring equity
  6. Vaccine will be delivered via the Vaccines for Children (VFC) model → direct shipped to providers
  7. Vaccine providers will be required to enroll in Vaccine Finder and report inventory daily

B. Priority Groups

  1. i. It should be noted that all are assumed susceptible to the virus
  2. ii. Initial populations prioritized for COVID-19 vaccination will likely be the following:
    1. Critical workforce members who provide health care
    2. Staff and residents in long term care facilities
    3. Critical workforce members who provide essential functions of society
  3. iii. Recommendations for groups to target will likely change after vaccine is available, depending on characteristics of each vaccine, vaccine supply, and disease epidemiology
  4. iv. Because of the uncertainty of COVID-19 vaccine production, plans must be flexible and should include high demand and low demand scenarios

C. Vaccination

  1. i. Adequate federal funding will be available to implement a large-scale vaccination response
  2. ii. Initial doses of COVID-19 vaccine may be authorized for use under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA), based on available safety and efficacy data
  3. iii. Cold chain storage and handling requirements for each COVID-19 vaccine product will vary from refrigerated (2°C – 8°C) to frozen (-20°C) to ultra-cold (-60°C to -80°C)
  4. iv. Most vaccines will be shipped in 100 dose increments kitted with ancillary supplies. Ultra-cold vaccine will be shipped in 1,000 dose increments
  5. v. Two doses of COVID-19 vaccine, separated by ≥21 or ≥28 days, will be needed for immunity for some vaccine candidates; It is expected that both doses of the vaccine will need to be with the same vaccine type, produced by the same manufacturer, but not the same lot of the vaccine. This will require stringent tracking of vaccine administered and patient reminders
  6. vi. Per CDC Guidance, 80% of the population will need to be vaccinated to achieve herd immunity
  7. vii. Vaccination will take place over many months and may unfold in phases, as more vaccine becomes available
  8. viii. Vaccine administration planning must reflect the four types of vaccines being manufactured:
    1. mRNA - messenger ribonucleic acid. Encodes protein of the virus which is inserted into cells to trigger an immune response and create antibodies to the virus
    2. Nonreplicating vector - injecting only certain proteins of the virus to stimulate the immune system. Uses a harmless viral vector to deliver the protein into the cells
    3. Protein adjuvant - virus protein is packaged into a nanoparticle and delivered into cells with an adjuvant to enhance the immune response
    4. Live attenuated - modify the virus to be inactive but still alive. Virus can infect the cells but not replicate to cause disease
  9. ix. CDC will provide standard communication materials on the EUA for the general public, similar to the Vaccine Information Statement (VIS), and specific communication to vaccine providers on the EUA
  10. x. Monitoring for adverse events will be very important
  11. xi. Vaccine distribution for common vaccine preventable diseases will not alter from routine procedures
  12. xii. Seasonal influenza vaccine production and campaign will continue
  13. xiii. Demand for the pandemic vaccine will be high throughout the response

NOTE: Requirements for COVID-19 vaccine administration will continue to evolve over time.

III. Concept of Operations

A. General

The IDPH Office of Health Protection (OHPt) Immunization Section and IDPH Office of Preparedness and Response (OPR) Medical Countermeasures Program have led the collaborative efforts of the COVID-19 Mass Vaccination Planning Work Group in developing this SARS-CoV-2/COVID-19 Mass Vaccination Planning Guide as an attachment to the Mass Vaccination Annex 3.0 of the State of Illinois Pandemic Plan. This guide should be used by state and local planners to design their efforts for the administration of the SARS-CoV-2/COVID-19 vaccine.

The IDPH/OPR Medical Countermeasures Program develops and maintains plans for request, receipt, distribution, mass dispensing and administration of life-saving emergency medical supplies and equipment during a disaster where the public's health is at risk. This includes plans in response to human-caused and natural events. The Medical Countermeasures Program includes the Strategic National Stockpile (SNS) Program, the CHEMPACK Program, the Illinois Pharmaceutical Stockpile (IPS) and the Cities Readiness Initiative (CRI). The SNS is a federal cache of emergency medical supplies and equipment that can be deployed to states during a disaster. The CHEMPACK is the forward placement of nerve agent antidotes. IPS is a state-owned cache of emergency medical supplies and equipment. The CRI is a program designed to ensure cross-border collaboration of municipalities, counties, and states during incidents where the emergency medical supplies and equipment are deployed.

The IDPH/OHPt Immunization Section maintains the Illinois Comprehensive Automated Immunization Registry Exchange (I-CARE), a system for vaccine management and operations, which includes ordering, shipping, handling, and storing procedures for all vaccine purchases in the State. I-CARE is the current system in use for the Vaccines for Children Program (VFC). The Vaccines for Children Program is a federally funded program that provides needed vaccines to children under the age of 19 years. Vaccines are provided at no cost to the provider or to the patient. Annually, IDPH coordinates the distribution of the seasonal influenza vaccine as part of the VFC program. IDPH does not maintain an adult immunization program. All other seasonal influenza vaccine must be procured directly by the provider and received via the manufacturer or distributor. Annually, VFC vaccines are shipped throughout the state of Illinois to approximately 3,000 enrolled public and private health care providers. Distribution of VFC vaccine is in accordance with the current Advisory Committee on Immunization Practices (ACIP) recommendations and children meeting VFC eligibility criteria. The eligibility criteria, much like vaccine prioritization categories, is monitored and enforced at the local level and reviewed by the IDPH Immunization Section staff for compliance as part of the mandated VFC site visits conducted biannually.

Administration of the SARS-CoV-2/COVID-19 Pandemic Vaccine

To accomplish the mission of providing SARS-CoV-2/COVID-19 vaccine to 80% of the residents of Illinois, the State of Illinois will:

  • Closely monitor activities at the local level to ensure the COVID-19 vaccine administration plan is implemented throughout the jurisdiction in adherence with federal guidance and requirements, and that there is equitable access to COVID-19 vaccination across the state
  • Activate the Illinois Department of Public Health’s Public Health Emergency Operations Center (PHEOC) and/or the State Emergency Operations Center (SEOC) to coordinate the ordering, administration, and tracking of the SARS-CoV-2/COVID-19 vaccine in the state
  • The Illinois Emergency Management Agency may opt to activate the State Emergency Operations Center (SEOC) to support the COVID vaccine administration efforts in the state
  • Ensure expanded scopes of practice for health care licenses to allow certain medical professionals the opportunity to assist in the mass vaccination campaign, when working under the authority of the local public health jurisdiction or a health care entity
  • Provide a statewide system for tracking vaccine administration and for notifying clients of the need for a second dose of the vaccine, if a second dose is needed
  • Provide a statewide system for volunteer management and tracking – Illinois Helps
  • Provide a statewide system for disseminating information to vaccine providers and other with direct involvement in the COVID-19 mass vaccination administration mission – Health Alert Network – HAN/ SIREN
  • Provide oversight of provider enrollment, tracking, and vaccine location oversight
  • Identify and map priority populations and determine sub-allocations of vaccine for distribution within the state
  • Provide guidance and training to vaccine providers on:
    • Available CDC resources, and vaccine recommendations, when available
    • Ordering and receiving the COVID-19 vaccine
    • Vaccine storage and handling, including transportation requirements, specific to COVID-19 vaccine
    • Vaccine administration, including reconstitution, use of adjuvants, diluents, etc
    • Documenting and reporting vaccine administration via I-CARE and/or EMTrack
    • Managing and reporting vaccine inventory via I-CARE
    • Documenting and reporting vaccine wastage/spoilage
    • Procedures for reporting to the Vaccine Adverse Event Reporting System (VAERS)
    • Providing Emergency Use Authorization (EUA) fact sheets and/or vaccine information statements (VISs) to vaccine recipients
  • Collaborate with local Public Information Officers (PIOs) to conduct a statewide media campaign to share facts about the vaccine and to encourage citizens to be vaccinated
  • Activate a statewide hotline to address questions regarding the mass vaccination administration campaign and to provide guidance on reporting vaccine adverse events to the Centers for Disease Control and Prevent (CDC)

Provider requirements, including local public health jurisdictions, hospitals, and others wanting to administer the COVID-19 vaccine:

  • All vaccine providers are required to register in I-CARE and sign and return the CDC COVID-19 Vaccination Program Provider Agreement and Profile form, electronically through I-CARE. Local public health jurisdictions, hospitals, and other vaccine administrators will order and receive the SARS-CoV-2/COVID-19 vaccine via I-CARE. Vaccine will be shipped directly from the federal government to the provider
  • Local public health jurisdictions should plan to collaborate with their regional health care coalitions, hospitals and long term care/assisted living facilities within the county, and with other potential vaccine providers that cater to critical infrastructure/essential workers in their jurisdiction to ensure full coverage of vaccine first, to the designated priority groups and finally, to the general public
  • All entities must provide training to staff assigned as vaccinators and to other staff members assigned to assist with vaccine administration operations
  • As part of the CDC COVID-19 vaccine provider agreement, the enrollee must attest/agree to being able to receive the vaccine and report to the IIS (I-CARE) within 24 hours of vaccine administration. Site visits are not required for COVID-19 vaccine providers, but the Chief Medical Officer associated with each site that signs the vaccine provider agreement is attesting that they meet the requirements listed in the agreement. For vaccine administration tracking and reminders of a second dose, if needed, all vaccine providers must plan to utilize I-CARE or EMTrack
  • All vaccine providers must daily report vaccine administration and on-hand inventory to IDPH for tracking and reporting data elements as defined by the CDC. CDC is using VaccineFinder to help facilitate reporting of COVID-19 vaccine supply, and as appropriate to help direct people to locations offering vaccine. All providers will need to report supply information into VaccineFinder (instructions from CDC will be forthcoming). The option for their site to be visible on the VaccineFinder public facing website will be available when/if providers want to increase access to vaccine to the public
  • All vaccine providers must share with vaccine recipients the required EUA fact sheets and/or VIS on the vaccine administered
  • All providers must include in their plans, procedures for reporting clinically important adverse events. Adverse events also will be monitored through electronic health records (EHR) – and claims-based systems such as Vaccine Safety Datalink
  • All vaccine providers must be registered in the Illinois Health Alert Network – HAN/ SIREN to receive vaccine guidance and critical updates on the COVID-19 mass vaccination administration mission. Vaccine ordering and distribution procedures are outlined in the Distribution Section of this document. Mass vaccination procedures are further described in local SNS/mass vaccination plans and in the State First Responder Prophylaxis Plan

B. Vaccine Ordering and Receipt

Note: As mentioned above, to be eligible to order vaccines, all vaccine providers are required to register in I-CARE, sign and return the CDC COVID-19 Vaccination Program Provider Agreement and Profile form, electronically through I-CARE.

  1. The IDPH Immunization Section will utilize their established I-CARE protocols to coordinate ordering and tracking utilization of the pandemic vaccines from the CDC, or from the designated vendors. Providers will log into I-CARE to order the vaccine. IDPH staff will approve the orders in I-CARE and transmit the request into CDC’s Vaccine Tracking System (VTrcks)
  2. The approved vaccine orders, including the adjuvant, if necessary, and all ancillary supplies, will be direct shipped to the providers designated location. This shipment is executed by McKesson or the vaccine manufacturer and will be expected to ship within 24 hours of the order being received through VTrckS. However, this timeframe is dependent on vaccine availability and on McKesson and the vaccine manufacturers to meet this timeline.
    ​Ancillary Supplies will be included in the shipment from McKesson or the vaccine manufacturer and consist the following: Supplies not included in the shipments from McKesson or the vaccine manufacturer and to be procured by the provider: Sharps containers, gloves, bandages, etc. Providers may need to plan for additional Personal Protective Equipment (PPE), depending on vaccination site needs.
    • Each kit will include supplies needed to administer 100 doses of vaccine
    • Needles, 105 per kit (various sizes for the population served by the ordering vaccination provider)
    • Syringes, 105 per kit
    • Alcohol prep pads, 210 per kit
    • COVID-19 vaccination record cards for each vaccine recipient, 100 per kit
    • Minimum personal protective equipment such as surgical masks and face shields for vaccinators. Each ancillary kit contains four surgical masks and two face shields
    • Needle information card, 1 per kit
  3. Minimum order size for CDC centrally distributed vaccine will be 100 doses per order for most vaccines. Minimum orders for ultra-cold vaccines that are shipped directly from the manufacturer will be 1,000 doses per package and will be shipped on dry ice. CDC will provide more detail on this as it becomes available
  4. Illinois will activate the Public Health Operations Center (PHEOC) and/or the State Emergency Operations Center (SEOC), once the vaccine administration mission commences. To ensure success of the mission, the Incident Command System will be expanded to include the following positions:
    1. The IDPH Immunization Group is the lead for processing and approving vaccine orders in I-CARE. The Immunization Group will also be responsible for monitoring patient tracking and for monitoring adverse events reporting. This group is headed by the Vaccines for Children Administrator and staff
    2. The Vaccine Administration Division is responsible for liaising with vaccine providers in each of the health care coalition regions and public health jurisdictions, by provider type.
      This group will be led by regional staff who have experience working with local health departments, hospitals, long-term care facilities, and the health care coalitions
    3. The I-CARE administration staff is responsible for COVID-19 vaccine provider enrollment and technical support. This group will be led by the I-CARE Administrator and staff
    4. The RSS/Distribution Group is responsible for tracking COVID-19 vaccine orders from the manufacturer direct-shipped to the providers. This group will be led by IDPH staff familiar with distribution operations
    5. See Attachment 1 for the IDPH ICS chart for planning and operations. All COVID-19 vaccine provider organizations should consider a similar ICS structure to organize their vaccine administration operations

C. Vaccine Allocation

Local public health jurisdictions should plan outreach to their regional health care coalition, the hospitals, long term care/assisted living facilities, and with other potential vaccine providers in their jurisdictions to determine each entity’s capacity to order and receive vaccine to assist with mass vaccination operations for their citizens.

  1. IDPH will estimate the overall public health jurisdictional allocations of COVID-19 vaccine based on population size, disease burden, vaccine availability and need, while ensuring equity.
    ​For example:
    1. IDPH receives an allocation of 200,000 doses of SARS-CoV-2/COVID-19 vaccine in I-CARE
    2. IDPH allocates pro rata share of vaccine to each jurisdiction; however, the base calculation will be adjusted to account for equity, potential hotspots and regional positions within the state.
      1. Cook County public health jurisdiction, the largest public health jurisdiction, outside of the city of Chicago, has 2.3 million citizens (Based on US Census, July 1, 2019), which is 28% of the Illinois population so will be allocated 28% of the 200,000 doses allocated to Illinois or 56,000 doses
      2. Calhoun County public health jurisdiction, the smallest public health jurisdiction in the State, has 4,739 citizens, which is 0.05% of Illinois population so will be allocated 0.05% of the 200,000 doses allocated or 100 doses. (Additional adjustments may be made based on equity, potential hot spots and regional positions within the state)
      3. Within the public health jurisdictions, vaccine will be further allocated to provider types based on priority groups, while ensuring equity in vaccine allocation and areas of vaccine availability:
        1. Health care workers
        2. Long term care staff and residents
        3. Essential workers
        4. Critical infrastructure personnel
        5. General population
  2. The City of Chicago will receive a separate, pro rata allocation of SARS-CoV-2/COVID-19 vaccine directly from the CDC
  3. A vaccine allocation tool designed to calculate each jurisdiction’s allocation has been developed and will be utilized for this event. The tool will list the public health jurisdictions, all eligible providers in the jurisdiction and their vaccine administration capacity so to efficiently allocate the vaccine in real-time as that information is received from the CDC
  4. Jurisdictions should anticipate that allocation strategies may shift during the response based on supply, demand, and needs within the state

D. Prioritization of Vaccine Allocation and Administration

Local public health jurisdictions should plan to collaborate with their regional health care coalition, hospitals, long term care/assisted living facilities, and with other potential vaccine providers in their jurisdictions that cater to critical infrastructure/essential workers in their jurisdiction to ensure full coverage of vaccine first, to the designated priority groups and finally, to the general public.

  1. Vaccine priority groups will be determined by the epidemiological data and will follow HHS and CDC guidelines based on input from the Advisory Council for Immunization Practices (ACIP). Vaccine providers should plan to focus their initial vaccine administration plans on those groups designated by the state of Illinois and the federal government as:
    1. Critical workforce that provides health care
    2. Staff and residents in long-term care and assisted living facilities
    3. Critical workforce that maintains essential functions of society

It is very important to outreach to these groups now to determine the number, type, and location of each priority group in the public health jurisdiction. Public health departments should coordinate with their health care coalition, emergency management, and other response partners to develop a list of entities serving the priority groups, determine their capabilities to serve as sites for vaccine administration, i.e. closed PODs, or develop plans for the local health department to service these groups at a general POD designed for these groups.

Based on CDC guidance, CDC COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020, jurisdictional partners should be planning in terms of three phases:

 

  1. Phase 1: Potentially limited supply of COVID-19 vaccine doses available. Vaccine administration strategies in phase 1 is broken into two sub-phases:
    1. Phase 1a – paid and unpaid health care workers. First responders – police and fire should be included in Phase 1a, but after health care workers
    2. Phase 1b – Other essential workers and persons at higher risks of severe COVID-19 illness, including persons 65 years of age and older
  2. Phase 2: Large number of vaccine doses available – critical populations, as defined by the CDC and ACIP first, then can transition to the general population
  3. Phase 3: Sufficient supply of vaccine doses for entire population (surplus of doses) – all groups are included in this phase

Once these priority groups have been satisfactorily reached, vaccine administration planning can then focus on reaching the general population where the goal is to ensure that at least 80% of the population is vaccinated.

Throughout each phase of COVID-19 vaccine administration, it is important that jurisdictions and providers ensure equitable allocation and administration of the vaccine to all identified priority groups and to the general public.

  1. For a definition of the critical workforce – see the federal guidance at https://www.cisa.gov/identifying-critical-infrastructure-during-covid-19 and the attached guidance from the Illinois State Police/ State – wide Terrorism Intelligence Center (STIC).
    1. Appendix 7 – Illinois Mass Vaccination Plan Discussion Points
    2. Appendix 8 – Appendix A_ Illinois Mass Vaccination Plan Discussion Points
  2. For guidance on setting up mass vaccination sites for priority populations, please see attached the closed points of dispensing/vaccination administration sites (POD) guidance developed by the IDPH/OPR.
    1. Appendix 9 – Illinois Closed POD Operations
    2. Appendix 10 – COVID-19 Vaccination – Record. Additionally, as indicated above, the ancillary supplies sent by CDC will contain a vaccine administration card for sharing with vaccine recipients
  3. To assist with mass vaccination operations at their POD sites, COVID-19 vaccine providers can utilize Illinois Helps to search for qualified volunteers.
    1. Illinois Helps (www.illinoishelps.net) is a state registry of volunteers for both medical and non-medical occupations, who can be activated in a disaster or public health emergency
    2. 38 states use a platform similar to this built on the federal standard Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP)
    3. Illinois Helps is owned by the Illinois Department of Public Health, managed by the Serve Illinois Commission in partnership with the system vendor Juvare. The Juvare suites of services utilized in Illinois includes: WebEOC, EMTrack, EMResource, and the Illinois HAN/SIREN
    4. Illinois Helps is a decentralized system whereby each organization (local health department, hospital, Medical Reserve Corps, Long Term Care facilities) manages individual volunteers that wish to work with that specific organization
    5. A volunteer comes into the system, gives their information including licensure and skills, and picks up to 15 organizations to work with
    6. The organization using the volunteer follows their own protocols, including background checks, if appropriate
    7. This is not an event-based system but rather a holistic volunteerism program whereby each organization works with volunteers in a variety of ways
    8. Approximately 270 qualifying organizations, such as local health departments, Medical Reserve Corps, hospitals, and long-term care facilities, are registered in Illinois Helps to request volunteers
    9. i. Any healthcare organization wishing to access and manage volunteers can request to do so at illinois.helps@illinois.gov

E. Tracking Vaccine Administration and On-Hand Inventory

All providers should plan to strictly adhere to the use of I-CARE for tracking vaccine administration and to report on-hand inventory back to IDPH and to the CDC.

  1. I-CARE
    1. The Illinois Comprehensive Automated Immunization Registry Exchange (I-CARE) is the state’s immunization information system (IIS) and will be the primary system utilized to order and track SARS-CoV-2/COVID-19 vaccine administration during an event
    2. I-CARE works by taking in data from a variety of sources, consolidating data into high-quality patient immunization records, applying vaccine evaluation and forecasting algorithms, and transforming this data into actionable information for clinicians, public health practitioners, and other IIS users to support immunization practice and improvement in one secured system
    3. Some functions support overall operations, like establishing interoperable connections with other systems and deduplication functionality for achieving high data quality. Other functionality supports clinical decision making for an individual patient, assessment of vaccine coverage rates for groups of patients or populations, reminder/recall outreach to improve vaccination rates, and management of vaccine inventory
    4. Community/Provider Benefit
      1. ii> Illinois’ IIS is fully implemented and functional. It meets all 12 minimum functional standards set forth by CDC for Immunization Registries
      2. iii> IDPH supports the goals and objectives of the Healthy People 2020 campaign. A goal that IDPH strives for every year is to increase the proportion of children under age 6 years of age, whose immunization records are in fully operational, population-based immunization information systems
      3. iv> Newborn patients are being added daily to I-CARE from the DPH Vital Records birth data import
      4. v> I-CARE receives data daily from many providers and hospitals submitting data using HL7 data exchange
      5. vi> All of the above will increase immunization rates and quality of care. More physicians will be able to verify the immunization status of patients, thus ensuring that those patients received needed immunizations without the risk of over immunization. Substantial cost savings will also be reached by ensuring that children get only the vaccines they need and do not receive unnecessary immunizations
    5. For access, all I-CARE providers must be pre-authorized via the IDPH Immunization Program
    6. Enrolling into I-CARE to receive COVID-19 vaccine is a two-step process: step 1 – complete the required enrollment forms to become an I-CARE provider; step 2 – complete the fillable CDC COVID-19 Vaccine Provider Agreement and Profile form, within I-CARE, to order and receive the vaccine. This includes agreeing to follow proper storage and handling procedures for each vaccine received
    7. There are three documents that are required to register an organization for I-CARE access.
      1. ii> The Provider Site Enrollment form
      2. iii> The Web Portal Registration Authority Agreement (PRA registration); each intended user will need to follow the IDPH Web Portal Online Registration Process to create their Username and Password
      3. iv> Individual User Agreement form stating and agreeing to IDPH security and confidentiality policies
    8. The COVID-19 Vaccine Providers Program Process and Guidance document is in development. The purpose of this document is to outline the requirements for approval to access I-CARE, levels of access available, roles in I-CARE, suggestions on who should have I-CARE access, frequently asked questions, and an online I-CARE training video
  2. Vaccine Administration Reporting
    1. Providers are required to submit daily accountability reports to IDPH in the format requested.
      1. ii> Daily reports must be submitted by 8:00 PM daily
      2. iii> The reporting frequency and required data metrics will be updated as more guidance is received from CDC
    2. IDPH is required to submit weekly inventory reports to CDC.
      1. ii> Weekly reports must be submitted to CDC by 4:00 PM CST
      2. iii> The reporting frequency and required data metrics will be updated as more guidance is received from CDC
  3. Quality Control
    1. IDPH performs quality control reviews of 25% of vaccine providers enrolled in the VFC program
    2. We anticipate using a similar protocol to review COVID-19 vaccine providers during this mission

F. Vaccine Distribution

All providers must have plans in place to receive vaccine and ancillary supplies shipped directly to the designated sites. Plans must reflect and adhere to the CDC’s requirements for storage and handling of the different types of vaccines.
In a pandemic, the state of Illinois has developed a two-tiered strategy to ensure vaccine delivery.

Tier 1

Tier 1 will utilize current shipping practices of the Vaccines for Children Program. Each local health department conducts routine pediatric immunization clinics and annual influenza clinics and has identified the resources necessary to conduct mass vaccination within the respective communities. Further distribution to sub-sites within the local jurisdictions, if necessary, is determined by the local health department and its community partners as part of that agency’s pandemic preparedness and response plans.

Distribution/delivery to each provider is currently performed via private carriers. Vaccine will be sent directly to vaccination provider locations for administration or designated depots for secondary distribution to administration sites. Once vaccine is shipped to a provider site, the federal government will not redistribute the product.

Under current vaccine delivery processes, the CDC contracts with a 3rd party distribution company, McKesson, to conduct the service. Some vaccines, i.e. those with ultra-low temperature requirements, will be shipped directly from the manufacturer to the providers.

Providers must ensure the proper equipment is in place and have developed plans to receive the vaccine directly from McKesson or the vaccine manufacturer at their designated site.

Public health jurisdictions are allowed to redistribute vaccines, while maintaining the cold chain. However, with the challenge of meeting cold chain requirements for frozen and ultra-cold vaccine, jurisdictions should be judicious in their redistribution and limit any redistribution to refrigerated vaccines only, if there is not a plan in place to maintain ultra-cold temperatures.

CDC does not advise providers to purchase ultra-cold storage equipment at this time. Ultra-cold vaccine will be shipped from the manufacturers in coolers that are packed with dry ice, can store vaccine for an extended period of time, and can be repacked for longer use. CDC will provide additional details as they become available.

Tier 2

Tier 2 serves as back-up and/or support to previous carriers and utilizes identified state partners such as the Illinois Department of Corrections that maintains refrigerated fleet vehicles for transport of biologics. If the Tier 2 Delivery method is needed, the Strategic National Stockpile Plan and Distribution Mechanism (Attachment 9 – Illinois SNS Plan, Annex 6, Distribution) will be activated via the SEOC supported by the Illinois Emergency Management Agency (IEMA). The Illinois Department of Transportation is the lead agency for transportation with the Illinois State Police providing security for delivery vehicles. The Illinois Department of Corrections and the Illinois National Guard provides back up transportation and security. Also, Illinois Department of Transportation has a Memorandum of

Understanding (MOU) with the Illinois Trucking Association to provide transportation assistance if needed. CDC has verified three (3) Receiving, Staging and Shipping (RSS) sites in the state. Additionally, Illinois has identified three sites strategically located within the state to receive federal assets, and a fourth to receive vaccines. From one RSS site in the state, the state agencies designated to carry out the mission, will transport the medical materials to designated Regional Distribution Center (RDC) that has been pre-identified.

There are four (4) RDCs identified in the state with back up sites. At the RDCs, material will be transferred to smaller vehicles, if needed and deployed to the affected area. Each certified health department in the state has identified a primary and secondary “Drop Site” to receive emergency medical material. (Attachment 10 – SNS Plan, Annex 6, Tab 18 - List of Local Health Department Drop Sites & Tab 19 – List of Hospital Drop Sites) All sites are verified by the state. From the RDC materials will be distributed to each county drop site, as well as each hospital in the affected area.

G. Site Security

In the event Tier 2 is implemented, whereby the SNS Delivery mechanism is needed, the Illinois State Police provide security for the distribution of emergency medical supplies. (Attachment 10 – Illinois SNS Plan Annex 5 – Security)
Badging/Credentialing

State ID badges are required for all state personnel involved with the Mass Vaccination receipt and delivery.

Local providers will show proof of employment of requesting agency

H. Vaccine Administration Tracking

All providers must plan to utilize I-CARE or EMTrack for vaccine administration tracking and reminders to recipients of a second dose, if needed.

Vaccine administration tracking is essential to the SARS-CoV-2/COVID-19 vaccine campaign for several reasons. Primary is that each citizenpersonperson may need to receive two doses of the same vaccine separated by 21 or 28 days. Another important reason is the need to track citizens for reporting of adverse events to the vaccine received. Assurance that all priority groups have adequate access to the vaccine and that 80% of population can be vaccinated in a timely fashion.

  1. For overall patient tracking in Illinois – I-CARE will be used to track individual patient information and conduct reminder/recall for additional doses
  2. At the provider level, two systems will be available in Illinois for patient vaccine administration tracking:
    1. I-CARE - For overall patient tracking in Illinois – I-CARE will be used to track individual patient information and conduct reminder/recall for additional doses
    2. EMTrack – part of the Juvare suite of services that includes WebEOC, EMResource, Illinois Helps, and SIREN. EMTrack is currently being used in Illinois by Emergency Medical Services (EMS) systems for patient tracking. The EMTrack Mass Testing and Vaccination Module was used for mass vaccination clinics during H1N1 and is regularly used at seasonal flu clinics. The Module enables clients to schedule an appointment and to be pre – screened for vaccination prior to coming to the vaccination site
  3. All providers should follow current guidelines for VFC vaccine disposal and recovery. Vaccine disposal and recovery procedures will be updated as more guidance is received from CDC

I. Vaccine Monitoring

All providers must include in their plans, procedures for reporting clinically important adverse events.

  1. Plans should identify a monitoring/safety coordinator and include 24/7 points of contact information
  2. Adverse Event Reporting
    1. The current Vaccine Adverse Event Reporting System (VAERS) system has been maintained for all suspected immunization adverse events and should be included in provider mass vaccination plans.
      VAERS reporting link: www.vaers.hhs.gov
      Phone: 800-822-7967
      Email: info@vaers.org
    2. VAERS is a national passive surveillance reporting system that is co-sponsored by the CDC and the FDA. Reports are accepted from anyone – vaccine recipients, health care providers, vaccine manufacturers, etc
    3. Patient identity is kept confidential. VAERS complies with all US government security standards and protections concerning health information
    4. Both public and private providers receive communication reminders of use of the online VAERS system
    5. VAERS contacts Immunization Group staff for any event that requires annual follow-up for final disposition. The IDPH/OHPt Immunization Section has also maintained the role of IDPH Ombudsman for VAERS with current staff to support any providers’ needs or requests
    6. Adverse events will also be monitored through electronic health record (EHR) – and claims-based systems (e.g. Vaccine Safety Datalink)
    7. Additional vaccine safety monitoring may be required under the EUA

J. Training

All providers should also ensure that their vaccinators and other staff involved in mass vaccinations operations receive training.
Training and exercise modules are continually being developed by the COVID-19 Mass Vaccination Work Group. The mass vaccination planning team will have 1-2 hour workshops with each region to go over the Mass Vaccination Planning Guide, review vaccine allocation tools, review the PanVax Tool, and answer questions of local staff. Follow up meetings will be scheduled with each region, as necessary. Additionally, IDPH plans to conduct three workshops/tabletop exercises for state partners. One will focus on Public Messaging (including the LHD Regional PIOs), the second will focus on using Tier 2 (IEMA/SNS) as a means of distribution of the vaccine, and the third will be geared towards Senior Leadership at IDPH and IEMA. The dates of these three workshops have yet to be determined. It is anticipated that most training and exercise offerings will be done virtually, with some on-demand options.

  1. I-CARE Training for Providers
    1. Is already available on-demand on the I-CARE platform
    2. This training is required for all those enrolled as a provider in I-CARE
  2. Vaccine Administration and Tracking
    1. In development
  3. Vaccine Call Down Drills and Exercises
    1. Call down drills will be conducted quarterly via the Health Alert Network (HAN)
  4. Just in Time Training for Tier 2 Distribution is developed and checklists are found in the SNS Plan
  5. Available CDC resources, and vaccine recommendations, when available
    1. To be determined
  6. Ordering and receiving the COVID-19 vaccine
    1. In development
  7. Vaccine storage and handling, including transportation requirements, specific to COVID-19 vaccine.
    1. To be determined
  8. Vaccine administration, including reconstitution, use of adjuvants, diluents, etc.
    1. To be determined
  9. Documenting and reporting vaccine administration via I-CARE or EMTrack.
    1. In development
  10. Managing and report vaccine inventory via I-CARE
    1. In development
  11. 1Documenting and reporting vaccine wastage/spoilage.
    1. To be determined
  12. 1Procedures for reporting to the Vaccine Adverse Event Reporting System (VAERS).
    1. In development
  13. 1Providing Emergency Use Authorization (EUA) fact sheets and/or vaccine information statements (VISs) to vaccine recipients.
    1. To be determined
  14. 1Public messaging.
    1. In development
  15. 1Outreaching to priority groups.
    1. In development
  16. 1Outreaching to vulnerable populations and hard-to-reach populations
    1. In development

K. Communications

All vaccine providers must be registered in the Illinois Health Alert Network – HAN/SIREN to receive vaccine guidance and critical updates on the COVID-19 mass vaccination administration mission.

The Illinois Health Alert Network – HAN/ SIREN is a statewide, web-based solution for quickly and effectively disseminating health information, for emergency notifications, and alerting staff. The system is a part of the suite of the Juvare services that includes WebEOC, EMTrack and Illinois Helps. It serves a central point in the State for finding, creating, and sharing information.

All COVID-19 vaccine providers must ensure that key staff members are register in SIREN to ensure that they are receiving information and updates on the COVID-19 mass vaccination mission. Also, COVID-19 vaccine provider organizations can utilize SIREN to communicate with their staff members and partners on organization specific information.

Please use this link to as a guide to the registration instructions for each public health related entity’s classification: http://www.dph.illinois.gov/siren and Appendix 11 for a description and more information the use of HAN/SIREN in Illinois.

L. Monitoring Resources

The Illinois Jurisdiction methods and procedure for monitoring budget resources include by grant number and categories the monitoring via an electronic ledger. Invoices are processed
electronically and request for purchase must have several levels of approval and adequate justification. All approved invoices and salary payments must be documented in the ledger prior to payment. The program manager reviews contracts, monitors and modify grants and contracts with adequate justification. The program manager assesses, reconciles and modifies the budget accordingly. The program manager and/or other appropriate staff plan and implement relevant competency training for staff (Microsoft package, Smartsheet, etc.) as needed.

The Illinois Jurisdiction methods and procedures for monitoring staffing resources include providing salary and justification in the federal CDC grant application budget. Each position must have at least an annual performance evaluation and work objectives must align with the Human Resource definition of the position. The program manager and/or appropriate supervising staff developed a tracking document to keep track of completed and pending evaluations, and ensure all pending evaluations are completed before the end of the year. Evaluations also identify areas of capacity improvement based on staff evaluations. Vacant positions are prioritized and prior to filling positions, documents justifying the positions, determining the hiring criteria, interview panel and questions must be submitted, reviewed and approved.

The Illinois Jurisdiction methods and procedures for monitoring supplies include electronically and manually monitoring inventory of supplies, annual comprehensive manual inventory assessment and real-time and regular electronic monitoring.

COVID-19 Mass Vaccination Planning Work Group

  • Illinois Department of Public Health
  • Illinois Emergency Management Agency
  • Illinois Department on Aging
  • Illinois Department of Central Management Services
  • Illinois Department of Corrections
  • Illinois Department of Financial and Professional Regulation
  • Illinois Department of Innovation and Technology
  • Illinois Department of Transportation
  • Illinois National Guard
  • Illinois State Police
  • Illinois Department of Healthcare and Family Services
  • Illinois Department of Human Services
  • Illinois Department of Innovation and Technology
  • Illinois Statewide Terrorism and Intelligence Center (STIC)
  • Illinois Department of Transportation
  • Illinois Department of Veteran’s Affairs
  • OHM Equity Team
  • University of Illinois, School of Medicine - Rockford
  • American College of Occupational and Environmental Medicine (ACOEM)
  • Local health departments

Acknowledgements:

* In addition, many federal partners, state private industry and state associations provided information that helped inform the planning process.

Acronyms

  1. ACIP - Advisory Committee on Immunization Practices
  2. ASPR – Department of Health and Human Services, Assistant Secretary for Preparedness and Response
  3. CDC – Department of Health and Human Services, Centers for Disease Control and Prevention
  4. EOP – Emergency Operations Plan
  5. EUA – Emergency Use Authorization
  6. ESF – Emergency Support Function
  7. HHS – US Department of Health and Human Services
  8. I-CARE – Illinois Comprehensive Automated Registry Exchange
  9. IDROP – Illinois 1st Responder Prophylaxis Plan
  10. IDPH – Illinois Department of Public Health
  11. IEMA – Illinois Emergency Management Agency
  12. IMATS – HHS/ ASPR Inventory Management and Tracking System
  13. IP – Immunization Program
  14. MOU – Memorandum of Understanding
  15. PHEOC - Public Health Emergency Operations Center
  16. RDC – Regional Distribution Center
  17. RSS - Receiving, Staging and Shipping
  18. SEOC – State Emergency Operations Center
  19. SNS – Strategic National Stockpile
  20. VAERS – Vaccine Adverse Events Reporting System
  21. VAMS – Vaccine Administration and Tracking System
  22. VFC - Vaccine for Children
  23. VMBIP - Vaccine Management Business Improvement Project