COVID-19 Vaccine

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. An EUA will allow use of a vaccine product to be used to prevent serious or life-threatening diseases or conditions when there are no adequate, approved, or available alternatives. 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: Are the COVID-19 vaccines safe and effective?

The FDA has fully approved one vaccine and granted Emergency Use Authorizations for other COVID-19 vaccines that have been shown to be safe and effective as determined by data from the manufacturers and findings from large clinical trials. These data demonstrate that the known and potential benefits of this vaccine outweigh the known and potential harms of becoming infected with COVID-19.

Moderna and Janssen/Johnson & Johnson COVID-19 vaccines are available for use under FDA Emergency Use Authorizations for use in individuals 18 years and older for primary doses and boosters. The Pfizer-BioNTech COVID-19 vaccine is available for use under an Emergency Use Authorization for children ages 5 through 15 years old, third doses for people 12 years old and older with weakened immune systems and boosters for individuals 16 years old and older. Pfizer-BioNTech COVID-19 vaccine was fully approved and licensed by the FDA in August 2021 for use in a primary series in people ages 16 years and older.

Safety and monitoring systems are in place to watch for adverse events (possible side effects). For facilities receiving vaccine through IHS, adverse events are reported to the CDC Vaccine Adverse Event Reporting System (VAERS). IHS-operated facilities are also reporting employee adverse events to the IHS Safety Tracking and Response (I-STAR) portal. An active surveillance survey across 58 direct and Tribal Health Program facilities also report adverse events biweekly. The IHS National Pharmacy and Therapeutics Committee issues COVID-19 updates, including details on newly authorized products and safety alerts.

Q: Is the IHS offering booster shots?

Yes, the IHS follows all approved recommendations for booster shots from the FDA and the CDC. The IHS is offering booster shots for those who completed their Pfizer-BioNTech, Moderna, or Janssen/Johnson & Johnson vaccinations, consistent with FDA and CDC guidance.

Q: Why are booster shots necessary?

After reviewing available data from the U.S. and around the world, and in order to enhance vaccine effectiveness and to combat COVID-19 and its variants, a booster dose is necessary to maximize and prolong protection. The available data make very clear that protection against COVID-19 begins to decrease over time following the initial doses of vaccination, and in association with circulating variants, we are starting to see evidence of reduced protection against mild and moderate disease.

At IHS, we remain vigilant and committed to protecting American Indian and Alaska Native communities from COVID-19 with safe, effective, and long-lasting vaccines. It is especially important as we are dealing with a constantly changing virus. Vaccines remain the most powerful tool we have against COVID-19.

Q: Am I eligible to receive a COVID-19 vaccine booster shot? When should I receive a booster shot?

The data and recommendations for COVID-19 vaccine booster shots continue to evolve. For information on COVID-19 booster shots, eligibility, and dosing intervals, please visit the CDC’s COVID-19 booster shot Exit Disclaimer: You Are Leaving www.ihs.gov  webpage. If you have questions about booster shots or are unsure of which COVID-19 vaccine booster is right for you, talk to your health care provider.

Q: Am I still considered fully vaccinated if I don’t get a booster shot?

Yes. At this time, people are still considered fully vaccinated two weeks after their second dose of the 2-dose Pfizer-BioNTech or Moderna vaccine series, or two weeks after the single-dose Janssen/Johnson & Johnson vaccine. An additional primary dose or a booster dose is not required to be considered fully vaccinated for public health purposes at this time. Individuals that received additional or booster doses when eligible are considered “up to date” with their COVID-19 vaccinations.

Q: Will booster shots be the same formulations as existing vaccines?

Yes, COVID-19 booster shots are the same formulation as the current COVID-19 vaccines. However, in the case of the Moderna COVID-19 vaccine booster shot, it is half the dose of the vaccine people get for their initial series.

Q: I heard about the availability of additional doses and boosters after completing a primary COVID-19 series for people who have weakened immune systems. How do I know if I am eligible?

People with weakened immune systems are especially vulnerable to COVID-19, including infection, breakthrough cases, and severe outcomes. The recommendations for additional and booster doses continue to be updated as more information emerges for this unique population. Visit the CDC’s COVID-19 Vaccines for Moderately or Severely Immunocompromised People Exit Disclaimer: You Are Leaving www.ihs.gov  webpage to view the most up-to-date recommendations, eligibility criteria and dosing schedules for additional and booster doses.

If you have questions about which COVID-19 vaccine shots you need and when they are due, talk to your health care provider.

Q: Can a Tribal Health Program or Urban Indian Organization receive vaccine from both the IHS and a state?

Tribal Health Programs and Urban Indian Organizations must participate in the CDC COVID-19 Vaccination Program to receive vaccine. Tribal Health Programs and Urban Indian Organizations choosing to participate in the CDC COVID-19 Vaccination Program coordinated through IHS are required to certify that they will not also sign participation agreements through a state or local jurisdiction.

Vaccine may be transferred or redistributed to IHS-operated facilities and facilities operated by Tribal Health Programs and Urban Indian Organizations participating in the CDC COVID-19 Vaccination Program Coordinated through IHS (I/T/U). The CDC Vaccine Allocation Transfer and Redistribution Guidance for IHS and Tribal Facilities Exit Disclaimer: You Are Leaving www.ihs.gov  outlines two methods to transfer vaccines to I/T/Us.

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?

Tribal Health Programs or Urban Indian Organizations are able to change jurisdictions for COVID-19 vaccine distribution. This should be coordinated through the Area Office and Area Vaccine Point of Contact. Enrolling and onboarding to a different jurisdiction may create a delay in receiving vaccine.

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. 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 according to the state’s requirements. 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 electronic version to ensure that the data is in the proper format for upload. The Vaccine Administration Management System (VAMS), a CDC supported platform, may be used to submit employee vaccine documentation (required for IHS-operated facilities), which as employee medical information should not be documented in electronic health records, and is an alternative vaccine administration documentation platform. COVID-19 vaccine orders, inventory and wastage will be documented through the VTrckS provider ordering portal (VPoP), a federal portal developed by Operation Warp Speed. For more information about the IHS vaccine administration electronic documentation process, please see Steps to Electronically Transmit Vaccine Administration Data.

Q: What is the distribution strategy that IHS intends to use to distribute the vaccine to Tribal Health Programs and Urban Indian Organizations?

IHS distribution strategy is based on several factors including: the number of vaccine doses allocated to IHS from Operation Warp Speed; the CDC’s Advisory Committee on Immunization Practices vaccination recommendations; population estimates gathered from IHS-operated facilities, Tribal Health Programs, and Urban Indian Organizations; vaccine shipping and storage requirements; and facility capacity. The IHS is coordinating vaccine distribution logistics through the National Supply Service Center (NSSC). The IHS NSSC works closely with Area Offices to coordinate vaccine shipments from McKesson or the manufacturer to health care facilities. During limited vaccine availability, the IHS NSSC will centralize vaccine ordering for facilities. As the vaccine supply increases to meet demand, vaccine ordering will move to local facility ordering through the CDC Vaccine Tracking System - Vaccine Provider ordering Portal (VPoP).

Q: Is there a difference in receiving vaccine coordinated through IHS or a state?

The IHS encourages Tribal Health Programs and Urban Indian Organizations to work with their local Area Office, Area Vaccine Point of Contact, and respective state to understand how COVID-19 vaccine is distributed in their region. Participation requirements in the CDC COVID-19 Vaccination Program are similar for all jurisdictions; however, there may be slight difference in the CDC COVID-19 Vaccination Program Agreements, reporting requirements, and capabilities at the local level. It is important for Tribal Health Programs and Urban Indian Organizations to consider all options available to determine how best to meet their population needs.

Q. How do Tribal Health Programs and Urban Indian Organizations choose to receive COVID-19 Vaccine from IHS?

Tribal Health Programs and Urban Indian Organizations interested in receiving COVID-19 vaccine from IHS should contact their Area Office and Area Vaccine Point of Contact, review the CDC COVID-19 Vaccination Program Agreement – Vaccines Coordinated through IHS for Tribal Health Programs and Urban Indian Organizations, review the Steps to Electronically Transmit Vaccine Administration Data, and submit a signed Program Agreement to the Area Vaccine Point of Contact.

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?

The IHS is committed to COVID-19 vaccine availability for all individuals within our health system as quickly as possible. In December 2020, the CDC Advisory Committee on Immunization Practices (ACIP) released vaccine priority group recommendations to include:

1. Phase 1a: health care personnel and long-term care facility residents.
2. Phase 1b: people ages 75 years and older and frontline essential workers.
3. Phase 1c: people aged 65 years and older and people 16 to 64 years old who have high-risk medical conditions, and other essential workers.

Because the epidemic is not the same everywhere, local jurisdictions have some discretion in how they set priorities and conduct their vaccine campaigns. It is understandable that IHS-operated facilities, Tribal Health Programs, and Urban Indian Organizations would know who in their communities need the vaccine first. The ACIP provides recommendations to assist in vaccinating at risk populations, but facilities can and should aggressively expand vaccinations to other priority groups if supply is available. Areas and facilities are offered flexibility to ensure vaccine availability as quickly as possible. IHS-operated facilities must ensure other identified priority group(s) meet the spirit of the CDC ACIP priorities, in accordance with IHS’ MOA with the CDC and IHS guidance.

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 a starting point for estimates, which may be complemented with other local data sources as needed. IHS population estimates include beneficiaries and non-beneficiaries, as reported by IHS-operated facilities, Tribal Health Programs, and Urban Indian Organizations. For Tribal Health Programs and Urban Indian Organizations interested in receiving vaccine from IHS, estimates should reflect local needs and include all persons, such as beneficiaries and non-beneficiaries, requiring vaccination. (See “non-beneficiaries” section for additional guidance on administering the vaccine to non-beneficiaries.)

Q: What is being done currently to ensure that communications are flowing to all stakeholders in the system, along with 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 COVID-19 website and provides 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 team that focuses on developing appropriate messaging to target priority populations. 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 were used to inform the IHS COVID-19 Pandemic Vaccine Plan, November 2020.

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.

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 its IHCIA contract or grant. 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 Tribal Health Programs and Urban Indian Organizations vaccinate employees, including employees who are not eligible urban Indians?

Yes, if the vaccine is administered as part of the Tribal Health Program or 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 Tribal Health Program or Urban Indian Organization may vaccinate all employees under such a program, including employees who are not otherwise eligible for patient services.

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?

The IHS is not storing and distributing vaccines from a central location. All sites can now order vaccines per requirement and get it shipped to the respective locations. However, IHS, in coordination with Area offices, may utilize a hub and spoke model to redistribute vaccine in smaller quantities to sites. The CDC is supportive of redistribution of vaccine as needed to meet the needs of the facilities. To redistribute vaccine, CDC COVID-19 Vaccination Provider Agreements would need to be in place for the sending and receiving facilities and a CDC COVID-19 Vaccine Redistribution Agreement signed and provided to the Area Vaccine Point of Contact. The IHS Supplemental Redistribution Guidance and Worksheet [PDF] are available on the IHS webpage for documentation of redistribution activities.