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COVID-19 Vaccine Planning

IHS Consultation and Confer

On November 18, 2020, IHS issued the IHS COVID-19 Pandemic Vaccine Plan November 2020 [PDF].

On October 14, 2020, IHS initiated tribal consultation and urban confer on the IHS COVID-19 Pandemic Vaccination Draft Plan. The written comment deadline was Wednesday, October 21, 2020.

On September 25, IHS issued a Dear Urban Indian Organization Leader Letter to initiate urban confer on COVID-19 Vaccination Planning for Indian Country. On October 8, IHS and CDC participated on a Virtual Listening Session with Urban Indian Organizations on COVID-19 Vaccine Planning and Distribution. The written comment deadline was Friday, October 9, 2020.

IHS developed and will continue to tailor the IHS COVID 19 Pandemic Vaccine Draft Plan based on available information and input received.

HHS Tribal Consultation COVID-19 Vaccination Planning for Indian Country

On September 24, the U.S. Department of Health and Human Services (HHS) initiated Tribal Consultation on the HHS vaccination planning for Indian Country. HHS hosted six tribal consultations on September 28, 29, and October 1. HHS representatives included the Centers for Disease Control and Prevention, Food and Drug Administration, IHS, and National Institutes of Health. The written comment deadline was Friday, October 9, 2020.

Updates

On November 30, HHS announced that all tribal health programs and urban Indian organizations have chosen their preferred method for receiving a COVID-19 vaccine when it becomes available. Tribal health programs and urban Indian organizations had the option of receiving the vaccine either through the IHS or their respective state. A list of federal, tribal, and urban facilities that will receive the COVID-19 vaccine from the IHS, broken down by IHS Area, is available here [PDF - 125 KB].

On November 18, 2020, IHS issued a Dear Tribal Leader and Urban Indian Organization Leader Letter [PDF] and the IHS COVID-19 Pandemic Vaccine Plan November 2020 [PDF].

On November 6, 2020, IHS issued Dear Tribal Leader [PDF] and Dear Urban Indian Organization Leader [PDF] Letters to provide an update on the IHS COVID-19 vaccination planning efforts. The letters include:

Tribal Health Programs and UIOs that choose to receive COVID-19 vaccine from IHS are requested to review, sign the agreements and submit to their respective Area Vaccine Point of Contact [PDF] as soon as possible.

On October 29, 2020, IHS issued Dear Tribal Leader and Dear Urban Indian Organization Leader Letters to provide clarification on COVID-19 vaccination of non-beneficiaries.

Additional Resources

The Food & Drug Administration held a Vaccines and Related Biological Products Advisory Committee on October 22, 2020 Exit Disclaimer: You Are Leaving www.ihs.gov .

Frequently Asked Questions (FAQs) regarding the COVID-19 Vaccine

The following FAQs reference Tribal Health Programs and Urban Indian Organizations. The Tribal Health Programs that are permitted to execute this Agreement are defined at 25 U.S.C. § 1603(25). The Urban Indian Organizations that are eligible to execute this Agreement must meet the definition at 25 U.S.C. § 1603(29) and receive funding from IHS under the Indian Health Care Improvement Act (IHCIA).

Q: What is Operation Warp Speed Exit Disclaimer: You Are Leaving www.ihs.gov ? And what is the Indian Health Service’s role?

Operation Warp Speed is a partnership among components of the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, and the Department of Defense. The Operation Warp Speed goal is to produce and deliver 300 million doses of safe and effective vaccines, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The Indian Health Service is recognized as a jurisdiction similar to a state by the CDC, to coordinate the distribution of COVID-19 vaccine. IHS is working with the CDC and Operation Warp Speed to develop a plan for direct IHS distribution of vaccine to tribes and urban Indian organizations that desire that option. The IHS Incident Command Structure established a COVID-19 vaccine task force on Sep. 4, 2020, to lead the COVID-19 vaccine activities. The task force guides development of action plans including prioritization strategies, distribution, vaccine administration, communications, data management, safety, and monitoring.

Q: What is an FDA emergency use authorization and how is it being used to respond to COVID-19?

The emergency use authorization (EUA) process is different than full FDA approval, clearance, or licensing because the EUA standard requires significantly less data than otherwise would be required for approval, clearance, or licensing by the FDA. For more information, please visit: What is an EUA Exit Disclaimer: You Are Leaving www.ihs.gov ? and the FDA in Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines Exit Disclaimer: You Are Leaving www.ihs.gov .

Q: How can American Indians and Alaska Natives be confident that the COVID-19 vaccines will be safe and effective?

The NIH is the nation’s medical research agency leading the clinical trials network for COVID-19 vaccines. NIH is ensuring diversity in clinical trials, recognizing that American Indians and Alaska Native communities should be included in the studies, because it is essential for the development of vaccines that are safe and effective for these communities. See more at NIH COVID-19 Communities Responding Together Exit Disclaimer: You Are Leaving www.ihs.gov .

On June 30, FDA released industry guidance Exit Disclaimer: You Are Leaving www.ihs.gov  providing recommendations to researchers and companies developing vaccine, emphasizing the focus on safety and effectiveness, as well as the importance of including diverse racial populations. The director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., stated that "we need to help expedite vaccine development as much as we can without sacrificing our standards for quality, safety, and efficacy." He also reinforced this point by saying, "But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency."

When a COVID-19 vaccine is FDA approved and distributed by IHS, ongoing safety will be monitored by multiple mechanisms through local and national reporting.

Q: Can a tribal health program or urban Indian organization elect to receive vaccine from both the IHS and a state?

No, each tribal health program and urban Indian organization must elect to receive vaccine from one jurisdiction, either the IHS or a state.

Q: Once a tribal health program or urban Indian organization elects to receive vaccine from either the IHS or a state, can that choice be changed?

IHS has requested clarification from CDC. At this time, IHS does not believe tribal health programs or urban Indian organizations will be able to change their selection.

Q: What are the data requirements for tribal health programs and urban Indian organizations when choosing between states and the IHS?

For the purposes of COVID-19 vaccine allocation and distribution, the CDC recognizes the IHS as a jurisdiction, along with states, to coordinate the distribution of COVID-19 vaccine for IHS, tribal health programs, and urban Indian organizations. CDC has developed standard data requirements that all health care facilities must meet for COVID-19 vaccine administration, inventory, and monitoring.

Tribal health programs and urban Indian organizations that choose to receive vaccines through a state must document COVID-19 vaccine administration with the state. States will use their existing immunization information system (IIS), or other specified platform as recommended by the state, for vaccine administration information. Ordering and inventory will be reported according to the state requirements. Additionally, all states will require inventory to be submitted through Vaccine Finder, a public facing searchable website. States may also have additional vaccine documentation processes or requirements. For more information, please see the CDC COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations Exit Disclaimer: You Are Leaving www.ihs.gov .

IHS-operated facilities, tribal health programs and urban Indian organizations that request the coordination of COVID-19 vaccine distribution through the IHS will document COVID-19 vaccine administration with IHS. The vaccine administration data for patients must be documented in their electronic health records, and an electronic data file will be used to upload the vaccine administration information to CDC. The electronic data will require a Health Level Seven (HL7) standard file format used by healthcare systems in the most recent version (2.5.1) to ensure that the data is in the proper format for upload. The Vaccine Administration Management System, a CDC supported platform, may be used to submit employee vaccine documentation (required for IHS Operated facilities) and is an alternative vaccine administration documentation platform. COVID-19 vaccine orders and inventory will be documented through a federal portal being developed by Operation Warp Speed.

If facilities report to both the state and IHS, it may create dual reporting.

Q: Will tribal health programs and and urban Indian organizations need to send in their own separate individual plans to IHS or to the state?

IHS is not requesting tribal health programs or urban Indian organizations to submit their own separate plans. Area offices are working with their IHS-operated facilities, tribal health programs, and urban Indian organizations to identify population estimates for COVID-19 vaccinations to assist with pre-planning efforts. IHS is not aware of state submission requirements. CDC is advising tribal health programs and urban Indian organizations to reach out to their respective states and local jurisdictions, and for states to reach out to them.

Q: What is the distribution strategy that IHS intends to use to distribute the vaccine to tribal health programs and urban Indian organizations?

The IHS pre-planning efforts include estimated populations for vaccinations. This information is used to inform IHS distribution efforts. IHS distribution will consider the recommendations from CDC on priority and target populations to inform distribution. IHS will be using the National Supply Service Center to coordinate distribution and vaccine will be shipped directly from McKesson or the manufacturer to healthcare facilities.

Q: Will the quantity of vaccine doses available to tribal health programs and urban Indian organizations be different depending on whether they receive vaccine from either the IHS or a state?

IHS anticipates equitable allocation of vaccine. There are no differences anticipated in timing or in types of vaccine or supplies between the IHS and states.

Q. How do tribal health programs and urban Indian organizations choose to receive COVID-19 Vaccine from IHS?

The CDC requires a COVID-19 Vaccine Program Agreement be signed by tribal health programs and urban Indian organizations, which request the coordination of COVID-19 vaccine distribution through IHS. States have a similar process for agreements.

Q: Will the IHS make decisions on critical populations and which to serve first and require tribal health programs and urban Indian organizations to follow those decisions?

IHS has collected preliminary data through the pre-planning tool. Decisions on critical populations will be based on final CDC recommendations, based on advice from the CDC Advisory Committee on Immunization Practices and as determined by local priorities.

Q: Is the IHS user population being used to determine priority population estimates?

For COVID-19 vaccine distribution purposes, IHS understands that user population may not capture all vaccination estimates for each tribal community. IHS user population may be used as an average number as a starting point for estimates, estimates may be complemented with other local data sources as needed. IHS is working with IHS, tribal health programs, and urban Indian organization health care facilities to gather appropriate estimates based on local needs.

Q: What is being done to ensure that communications are flowing to all stakeholders in the system, along with material resources or technical assistance needed?

The IHS Incident Command Structure ensures critical information is shared across the system. Area directors are critical in ensuring that "on the ground" updates are shared at area and national levels. IHS also issues updates on its coronavirus website and provides bi-weekly email updates to tribes, tribal organizations and urban Indian organizations to share critical information and provides important updates, including resources or technical assistance, on the COVID-19 response. Additionally, the IHS vaccine task force includes a communications workgroup which will focus on developing appropriate messaging to target priority populations when a vaccine becomes available. In September 2020, HHS hosted regional tribal consultation sessions to obtain feedback on the CDC COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations Exit Disclaimer: You Are Leaving www.ihs.gov . IHS and other HHS agencies participated on all six regional consultation sessions and heard important feedback regarding vaccine distribution planning, reporting requirements, and vaccine safety and monitoring. On Oct. 14, 2020, IHS issued the COVID-19 Pandemic Vaccine Draft Plan for review and comment through Oct. 21. Feedback on the draft plan and pre-planning tool estimates will be used to inform the final IHS plan.

Q. Can IHS-operated facilities and tribal health programs provide the vaccine to non-beneficiaries?

IHS has the authority to vaccinate non-beneficiaries to prevent communicable disease according to 25 U.S.C. § 1680c(d)(2). This authority may be utilized by tribal health programs, should they wish to exercise the authority for their programs, assuming it is consistent with the terms of their Indian Self-Determination and Education Assistance Act agreement with IHS. The patient’s health insurance can be billed for the cost of administration or, if applicable, the uninsured fund, but the patient should not be charged. With regard to the costs of administering the vaccine at IHS and tribal health programs, IHS is working to determine what funds are available and authorized for the purpose of administering the vaccine, and will be issuing guidance on those questions in the future.

Q. Can urban Indian organizations provide the vaccine to patients who are not eligible urban Indians?

The CDC COVID-19 Vaccination Program is intended to provide the vaccine to all citizens who wish to be vaccinated. Therefore, urban Indian organizations may use CDC COVID-19 vaccines to vaccinate all patients. A separate question is how urban Indian organizations will fund their costs of administering the vaccine. As with all services they provide, urban Indian organizations must carefully distinguish their IHS funding for urban Indian health from funding that is available for other individuals. Urban Indian organizations may use their IHS funds only for the cost of administering the vaccine to “urban Indian” patients, as defined by the Indian Health Care Improvement Act (IHCIA) and in their contracts with IHS. Accordingly, for any CDC COVID-19 vaccines administered to patients who are not eligible urban Indians, an urban Indian organization cannot use funds received from the IHS under their IHCIA contracts or grants. Urban Indian organizations must use another authorized source of funds to cover such costs. While the urban Indian organizations can bill the patient’s health insurance or, if applicable, the uninsured fund, the patient should not be billed.

Q. Can urban Indian organizations vaccinate employees, including employees who are not eligible urban Indians?

Yes, if the vaccine is administered as part of the urban Indian organization’s employee health and safety program or as a health clinic or wellness center offered to "improve working conditions, employer-employee relations, employee morale, or employee performance." See, e.g., 48 C.F.R. § 352.223.70; 48 C.F.R. § 31.205-13(a). The urban Indian organization may vaccinate all employees under such a program, including employees who are not eligible for patient services because they are not an eligible urban Indian.

Q. Can urban Indian organizations vaccinate a parent/spouse/partner/caretaker who is not an eligible urban Indian?

Yes, since the CDC COVID-19 vaccines can be used to vaccinate all patients. However, as stated above, the individual must be an eligible urban Indian patient for the urban Indian organization to use IHS funds for the costs of administering the vaccine. Therefore, if the parent/spouse/partner/caretaker is not an eligible urban Indian, the urban Indian organization must use another authorized source of funds to cover its costs of administering the vaccine to that patient. While the urban Indian organizations can bill the patient’s health insurance or, if applicable, the uninsured fund, the patient should not be billed.

Q: Does the IHS plan to store vaccine at a central location and distribute it as needed? Is this possible to address cold-chain issues to serve our smaller and more isolated locations?

IHS is reviewing information submitted from the facilities and areas via the pre-planning tool. This includes reviewing various types of storage available (frozen, refrigerated, and ultra-cold), capacity and geographic locations of each facility. The CDC is supportive of redistribution of vaccine as needed to meet the needs of the facilities. Provider agreements would need to be in place for each of the facilities.

Q: Do facilities need to purchase an ultra-cold freezer?

The CDC is not advising the purchase of an ultra-cold freezer. If a COVID-19 vaccine requires ultra-cold storage, it will be shipped directly from the manufacturer in containers that can maintain ultra-cold temperatures for 10 days from the time of shipping and they may be recharged with pelletized specialty dry ice every five days up to three times. The ultra-cold COVID-19 vaccine can also be stored for up to five days at two to eight degrees Celsius (refrigerated temperatures). Ultra-cold COVID-19 vaccine will be shipped with minimum order quantity of 975 doses in the early phases of distribution.