Adult Vaccine Access Coalition’s Recommendations to Strengthen Immunization Infrastructure for COVID-19 Response
The Adult Vaccine Access Coalition (AVAC) would like to take this opportunity to share ideas to help strengthen and enhance immunization infrastructure in the context of COVID-19 public health response efforts. The CARES Act provided an infusion of resources to help address immediate resource needs. However, as stakeholders across industry, academia, and government search for a COVID-19 vaccine to protect the public, policymakers and the health care system must take steps now to prepare to distribute a new vaccine once it becomes available. These recommendations have been developed and reviewed by AVAC members and reflect policies that are going to help providers on the ground prepare for a forthcoming COVID-19 vaccine as well as effectively manage ongoing routine vaccination efforts, including the upcoming annual flu season.
AVAC urges Congress to authorize and provide funding for these efforts under the leadership of Department of Health and Human Services, through the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), the Health Resources and Services Administration (HRSA), the Administration for Community Living (ACL), the Office of the National Coordinator (ONC). HHS should establish an interagency task force to coordinate with the Department of Defense, the Department of Veteran’s Affairs and the Department of Justice Bureau of Prisons, along with health care stakeholders, including public health organizations, health care provider organizations (physicians/pharmacists/nurses) and immunization information system and electronic health record experts to prepare our immunization infrastructure in the following ways:
1) Follow the H1N1 playbook and leverage learnings from the H1N1 experience:
In 2009, the country faced an influenza pandemic with novel influenza A (H1N1). The federal government financed the development of a vaccine and provided the vaccine free of charge to Americans.1 The vaccine was distributed through existing centralized vaccine ordering and distribution systems.2 States allocated vaccines to providers who agreed to prioritize specific populations for the vaccination as instructed by states based on Advisory Committee on Immunization Practices (ACIP) guidance. Funding to prepare for and carry out mass vaccination with H1N1 vaccine was provided by Congress through CDC to state and local public health agencies through the Public Health Emergency Response program.
2) Begin planning for vaccine distribution now through existing public health immunization infrastructure.
Governors and COVID-19 state and local operational and planning teams should include immunization, emergency preparedness, housing, aging and justice program leadership, provider organizations and health systems. They should work from pandemic influenza vaccine distribution plans, and address before vaccine supply becomes available any existing regulatory barriers to provider and patient access to the novel coronavirus vaccine. Plans should also account for resource needs for the provision of routine immunization efforts and annual flu vaccine efforts. During H1N1, vaccine supply shipments began as soon as the vaccine was available but it will take weeks or possibly months to have sufficient supplies of a COVID-19 vaccine distributed around the country for all who require it. Vaccine supply distribution must be prioritized based on ACIP guidelines and address potential socio-economic or ethnic access
3) Assess and provide resources necessary for Immunization Information Systems (IIS) enhancements for accelerated and expanded provider registration, vaccine distribution, vaccine accountability, dose administered reporting, patient recall if a second dose is needed, and adverse event tracking. Areas of focus in preparation for a new COVID-19 vaccine will include:
Governmental level proposals:
- Provide guidance on relaxing data restrictions and consent requirements that hinder timely reporting of evidence of immunity (through approved serological testing confirmation or history of disease from a positive lab test result) or record of immunization by state/local/tribal/territorial entities for COVID-19. Similar actions were taken during the H1N1 influenza pandemic in 3
- Implement CDC’s HL7 reporting standards and coding4 for recording and exchanging immunizations and include in IIS standards the ability to collect and store evidence of immunity and lab results
- Assess and address IIS infrastructure needs and resources necessary through a landscape analysis of current capabilities and functionality to establish standards-based interoperable data exchange connections to aid communication between state/local/tribal/territorial IIS systems, immunization providers and health systems, and the CDC.5
- Develop process for rapid post-marketing surveillance (e.g. rapid cycle analysis and prospective EHR analysis from public and private health insurers to look at prespecified adverse events) and an effective means of regularly communicating results to the Establish an interagency HHS task force to provide updates to the National Vaccine Advisory Committee (NVAC).
Provider level proposals:
- Recruit and register willing providers (organized based on populations and geographic areas they serve) to provide and report
- Provide incentives and support to smaller providers (physician offices/community health centers/community pharmacies) to participate in pandemic vaccination and adopt IT systems necessary to enable timely reporting of COVID-19 immunity or vaccine administration to IIS through a certified electronic medical record or pharmacy record/documentation
- Provide vaccine and vaccine supply ordering capacity to providers and approval through state allocation
- Track vaccine uptake in priority groups and report doses administered in real time.
- Account for vaccine use and replenish
- Document vaccine and adjuvant (if needed) by lot number or another unique identifier and capacity to conduct patient reminder recalls if two doses are needed.
- Enable secure consumer access to personal immunization records (through printing or other means) to enable individuals to provide documentation and share information with a person’s medical home if a vaccine is administered elsewhere (e.g. vaccination clinic).
4) Assess and provide for additional staffing needed to onboard providers and assure orderly vaccine distribution that is consistent and targeted to priority populations.
- Providers who serve all populations, but especially those prioritized for vaccine or at high risk for serious SARS-CoV-2 disease outcomes, need to be identified and enrolled as vaccinators and staffing plans must be developed for mass vaccination clinics. During the 2009 H1N1 pandemic, states enrolled approximately 3 times the number of providers for the vaccination
- Develop COVID-19 vaccine allocation plan to assure that initial vaccine supplies are effectively prioritized and equitably distributed across providers and geographic areas to meet patient and community access
- Ensure adequate staffing to maintain routine vaccination activities, particularly related to influenza, contain ongoing regional outbreaks of vaccine-preventable diseases (measles, hepatitis, pertussis) and support immunization efforts across the lifespan. Many states have been forced to suspend surveillance and outbreak response activities around hepatitis A and hepatitis B as a result of the coronavirus outbreak. Explore feasibility (based on the availability of financial resources, vaccine supplies and staffing) of providing multiple vaccines in one visit (e.g. COVID and flu) based on ACIP
5) Scale up outreach and communication.
- Develop plans for educating Americans about the COVID-19 vaccine and inform consumers how to access vaccine when one becomes
- Train and/or recertify providers on vaccine storage and handling, administering, IIS reporting as well as capability to provide information and ongoing communication and guidance relative to vaccine orders and supplies.
- Continue messaging on the importance of routine preventive health and standards of immunization care in order to address gaps in vaccine confidence and trust in
6) Prepare and implement policies needed for large scale vaccination. Elements that need to be addressed include:
- Prioritization plan and funding for federal government purchase and equitable distribution of
- Memorandum of Understanding agreements with pharmacy providers (corporations, pharmacy networks, health systems, etc.) and licensing accommodations for providers enlisted to participate, such as healthcare professional students, dentists
- Guidance to allow the greatest number of vaccinators possible, including authority for pharmacists, as well as other diverse healthcare specialists and providers, such as endocrinologists, cardiologists,
- Assessment of pandemic vaccination plans to accommodate local factors and overcome challenges (Locations such as community health centers, senior centers, schools, hospitals, pharmacies, drive through clinics, meal delivery ; staffing; vaccine transport; data collection; scheduling, security, etc.)
- Scale the ability of IIS to safely and confidentially exchange data across jurisdictions and have this data available to clinicians to ensure coverage of all segments of the
- Establish linkages between IIS and Vaccine Adverse Event Reporting System (VAERS) to monitor vaccine outcomes and document and investigate potential vaccine adverse
We appreciate this opportunity and hope this information is helpful as Congress and the Administration continues to work to respond to the many facets of the ongoing COVID-19 pandemic. If you have any questions or would like to discuss any of the ideas provided in additional detail, please contact AVAC Managers Abby Bownas (abownas@nvgllc.com) or Lisa Foster (lfoster@nvgllc.com).
Sources:
1 https://www.gao.gov/new.items/d11632.pdf
2 https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/SCLetter-10- 06-Influenza.pdf
3 https://wwwnc.cdc.gov/eid/article/20/4/13-1114_article
4 https://www.cdc.gov/vaccines/programs/iis/technical-guidance/hl7.html