Answers to your most pressing vaccine questions can be found on the IHS and CDC websites here:
https://www.ihs.gov/coronavirus/vaccine/
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html
Q: What is Operation Warp Speed ? 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 (CDC), the U.S. Food and Drug Administration (FDA), 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 CDC is working with other jurisdictions, including state, territorial, tribal, and local public health programs, to coordinate the distribution of COVID-19 vaccine. The CDC also recognizes the Indian Health Service (IHS) as a jurisdiction for the purpose of coordinating the distribution of COVID-19 vaccine. IHS is working with the CDC and Operation Warp Speed to distribute COVID-19 vaccine to IHS-operated facilities, as well as Tribal Health Programs and Urban Indian Organizations that choose to receive vaccine coordinated through IHS instead of their state. The IHS Incident Command Structure established a COVID-19 vaccine task force on Sep. 4, 2020, to lead the IHS’s 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. 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 ? and the FDA in Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines .
Q: Are the COVID-19 vaccines safe and effective?
The FDA has granted Emergency Use Authorizations for 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. 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.
