Two vaccine developers recently announced successful late-stage clinical trials, with Pfizer trials reporting more than 90% efficacy and Moderna trials reporting almost 95% efficacy at preventing COVID-19. Both Pfizer and Moderna have indicated they will be applying for emergency use authorization from the FDA in the coming weeks or even days.
The Pfizer vaccine requires ultracold storage at minus 70 degrees Celsius, and Moderna requires cold storage at minus 20 degrees Celsius. Operation Warp Speed is working to develop storage solutions for administration sites without the capacity for ultracold or cold storage, such as shipping the vaccines in storage units with dry ice, and allowing vaccine storage sites to replace the dry ice to extend the life of the vaccine in its shipment container.
Both Pfizer and Moderna vaccines require a second dose 21 and 28 days later, respectively. Vaccine kits will include cards to track which vaccine was received, and when the second dose is needed. Patients will be encouraged to take a picture of their cards in case the cards are lost.
PPE required to administer the vaccine will be provided with the doses. Except for Pfizer, whose kits contain 975 doses, all vaccine candidates will be distributed in kits with 100 doses. (Six manufacturers currently are working on vaccine candidates.) Pfizer will ship vaccines directly to administration sites, while other vaccines will go from the manufacturer to McKesson, the federal contractor responsible for distribution.
Allocations will be provided on a pro rata basis by populations, with the initial phases of vaccine doses for healthcare workers and highest-risk individuals. Healthcare personnel have been identified as the likely Phase 1a population that will receive the first 20 to 40 million vaccine doses in the United States. It is important to recognize the many unknowns that exist: for example, the efficacy of any given vaccine in patients of different ages, or with certain conditions, and how that might influence the prioritization considerations for that specific vaccine.
On November 18, 2020, IHS sent a Dear Tribal Leader Letter and the IHS COVID Pandemic Vaccine Plan – November 2020. The IHS plan includes additional information about the IHS vaccine distribution process and requirements. IHS will continue to provide updates as they become available.
Tribes should have submitted their decisions by November 6, 2020 regarding whether they intend to enroll with their state’s Department of Public Health or with Indian Health Service for vaccine administration. IHS has developed a “Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program Tribal Health Program Agreement, for Vaccines Coordinated through IHS for Tribes with Tribal Health Programs.”
On November 6, 2020, IHS sent a Dear Tribal Leader Letter that indicated a November 15 deadline for tribal health programs choosing to receive COVID-19 vaccinations through IHS, and directed leaders to complete and submit this program agreement to their IHS area vaccine point of contact. Tribes should verify that their qualifying tribal health programs submitted this completed program agreement.
For direct service tribes, IHS plans to enter into a CDC COVID-19 Vaccination Program Memorandum of Agreement with the CDC regarding the Federal Agency Vaccination Program. IHS Direct Service facilities will receive a copy o the COVID-19 Vaccination Program Agreement signed by the IHS director. Facilities that will be receiving COVID-19 vaccines must complete “Form B” and return it to their IHS area vaccine point of contact (see document link above).
Tribes that enrolled with their states should reach out to state contacts for enrollment details.
Tribes also need to make sure they have submitted preliminary planning information to IHS regarding priority population. IHS has identified facilities that will use the IHS NSSC for vaccine distribution, and estimates for the amount of vaccines they will require. The facilities reported these estimates, which IHS will use to determine the size of vaccine priority populations. IHS is working with the facilities to ensure that they’re using the most accurate information available for identifying vaccine requirements.
There will be an IHS COVID-19 Vaccine Planning and Implementation conference call on Friday, November 20, 2020 from 12:30 to 1:30 p.m. EST. The event is targeted for healthcare providers. Information on how to join the event will be provided through the online IHS calendar, and attendees can register here.
New daily COVID cases and hospitalizations are currently the highest they have ever been. We encourage you to continue to wear a mask, wash your hands, maintain social distancing, follow local public health restrictions, and get a flu shot.