OPERATION WARP SPEED DISTRIBUTION PROCESS

IN SUPPORTING THE DISTRIBUTION & ADMINISTRATION OF COVID-19 , OWS HAS FOUR KEY GOALS, TENETS, AND ARCHITECTURE

Ensure safety and Reduce morbidity and Support rapid vaccine Assist with the effectiveness of mortality of COVID-19 distribution based on return to COVID-19 vaccines disease through CDC guidance for pre-pandemic effective and efficient states immunizations quality of life distribution of services COVID-19 vaccines

DISTRIBUTION AND ADMINISTRATION OF A COVID-19 VACCINE FOUR KEY TENETS

CONTROL/VISIBILITY COVERAGE Where vaccines and secondary item kits are at all Deliver vaccines beyond the normal brick and mortar times in the process of distribution and ensuring the facilities, including potential mobile or on-site vaccines go to prioritized groups as determined by delivery of vaccine to long-term healthcare facilities policy and other hard to reach populations

UPTAKE TRACEABILITY How many vaccines were administered per location Confirm which of the approved vaccines were administered: per day to match supply with demand • Regardless of location (private/public) • Reminder to return for second dose • Administer the correct second dose

TRIALS

MANUFACTURING FDA MANUFACTURER OWS & CDC Based on data from clinical trials, Vaccine is being manufactured Allocation of initial/limited doses will be vaccine candidate is submitted for concurrent with clinical trials, based on CDC prioritization models Emergency Use Authorization (EUA) and upon EUA/BLA and CDC • Independent advisory panel (Advisory Committee on or Biologics License Application recommendation, vaccine is Immunization Practices with input from Nat’l (BLA) ready to ship Academies of Science) informs CDC prioritization • Reviews EUA/BLA application • Initial/limited doses will be allocated for • Approves EUA/BLA application specific groups • Oversees ongoing reporting Oversees distribution of vaccine • Pharmacovigilance ○ ○ Tracks product that is delivered/administered

ADMINISTRATION SITES DISTRIBUTION FACILITIES DISTRIBUTOR Vaccines, upon EUA/BLA, are ready to Vaccines & associated ancillary • Maximize use of existing pharmaceutical ship to: kits (syringes, needles, and distribution infrastructure • Pharmacies alcohol swabs) will be shipped • Central Distributor established for kitting • Nursing homes concurrently to distribution & distribution operations • Public Clinics depots and facilities • Hospitals • IT infrastructure supports ordering, • Doctor's offices and Mobile Clinics distribution, administration, and tracking • Military Treatment Facilities end-to-end

PHARMACOVIGILANCE (FDA & CDC) 24 month post trial monitoring for adverse effects/additional safety feature