Discussion

COVID - 19 VACCINATION SCENARIOS FOR

JURISDICTIONAL PLANNING PHASE 1 , Q4 2020

The planning scenarios described below should be used by state and local jurisdictions to develop operation plans for early COVID -19 vaccination when vaccine supply may be constrained . The scenarios describe potential COVID - 19 vaccine requirements , early supply estimates after vaccine product approvals , and populations that may be recommended for vaccination during this early period . These scenarios are designed to support jurisdictional , federal , and partner planning , but they are still considered hypothetical . The COVID - 19 vaccine landscape is evolving and uncertain , and these scenarios may evolve as more information is available .

Planners should assume that by January 2021 significantly more COVID- 19 vaccine will be available for distribution and

plans will need to evolve to address additional vaccine availability . Please refer to COVID - 19 vaccine planning

assumptions and additional guidance from CDC.

Scenario 1: Vaccine A demonstrates sufficient efficacy / safety for EUA in 2020

Availability Assumptions

Candidate End of Oct 2020

doses

Vaccineavailabilityby End of Nov 2020

10–20Mdoses

End of Dec 2020

doses

Notes

Ultra -cold (-70 ° C), for large sites onlyVaccine A

Distribution, Storage, Handling and AdministrationAssumptions

Vaccine A

SHIPMENT ON-SITE VACCINESTORAGE 3 separatelyacquiredcomponents(mixedon site) Frozen( -70 ° C ° C ) 1. Vaccine Must be used/ rechargedwithin 10 days

Directto site from manufacturer(on dry ice) Storage in shipping container OK ( replenish dry ice as Multidose vials (5 doses/ vial ) needed)

2. Diluent Thawed but NOT reconstituted ( 2–8 °C ) Direct to site from USG ( at room temperature ) Must use within 24-48 hours

3. Ancillary supply kits Reconstituted ( room temperature) Direct to site from USG ( at room temperature) Mustuse within6 hours

ORDERS ADMINISTRATION

Largequantities, to largeadministrationsitesonly 2 -doseseries 21 daysbetweendoses) Minimumorder: 1000doses On-site mixing required; reconstitutewith diluentjust prior

Maximumorder: 5,000 doses to administration

Administer by intramuscular ( IM ) injection PRIORITIZED POPULATIONS AND ANTICIPATED VACCINE ADMINISTRATION SITES Health care professionals ( incl. LTCF staff) public health closed temporary mass vaccination clinics + potential for mobile clinics Essential workers ( specifics TBA – public health closed temporary mass vaccination clinics + potential for mobile clinics National Security populations public health closed temporary mass vaccination clinics + sites LTCF residents & staff potential for mobile clinics to facilities

Additional Considerations for Early Vaccination Planning

August 26, 2020

COVID- 19 VACCINATION SCENARIOS FOR

JURISDICTIONAL PLANNING PHASE 1 , Q4 2020

Jurisdictions should plan for real-time shipment of doses.

Administrationsites ( during Phase 1) will not be required to store vaccine products beyondthe period of time Vaccine A can be stored in the ultra- cold shipment box.

Vaccine will be free of cost, but administrationfees may not be reimbursablewhile a vaccine product is administered under an EUA

Given the challenging storage, handling, and administrationrequirements, early vaccination should focus on

administrationsites that can reach prioritized populationswith as much throughputas possible.

Stability testing is ongoingfor Vaccine A ; the storage and handling requirementspresented here may shift. The

requirementsin these scenarios are likely the strictest set of requirementsfor which planningis needed.

Jurisdictions should consider partneringwith the private sector and with local hospital systems to providevaccine in closest proximityto the prioritized populations as possible, given the limitationswith the product. For example:

Vaccine A may be administeredthrough mobile clinics if multiple mobileclinics are plannedover a short periodof time

to ensure high enough throughput.

August 26, 2020

COVID- 19 VACCINATIONSCENARIOS FOR

JURISDICTIONAL PLANNING PHASE , Q4 2020

Scenario 2 : Vaccine B demonstrates sufficient efficacy / safety for EUA in 2020

Availability Assumptions

Candidate

Vaccineavailabilityby End of Nov 2020

10M doses

End ofOct 2020

1M doses

NotesEnd of Dec 2020

15M dosesVaccine B Central distro capacity required ( -20 °C)

Distribution, Storage, Handling and AdministrationAssumptions

VaccineB

SHIPMENT ON-SITE VACCINE STORAGE

2 separately shipped components Frozen (-20 ° C ) 1. Vaccine Storage in shipping container OK ( replenish dry ice as

To central distributor ( at -20 ° C) needed) Multidosevials ( 10 doses/ vial) Refrigerated ( 2–8 ° C )

2. Ancillary supply kits Must use within 7-14 days

Direct to site from USG (at room temperature ) Room temperature Mustuse within6 hours

ORDERS ADMINISTRATION

Central distribution capacity required 2 - dose series ( 28 days between doses) Required by Dec 2020 No on -site mixing required Maintained at -20 ° C Administerby intramuscular(IM ) injection

PRIORITIZED POPULATIONS AND ANTICIPATED VACCINE ADMINISTRATION SITES

Health care professionals( incl. LTCFstaff) – health care clinics + health care occupational health clinics + public health closed temporary mass vaccination clinics + mobile clinics

Essentialworkers ( specifics TBA ) – hospital occupational health + hospital clinics + public health closed temporary mass vaccination clinics

NationalSecurity populations + closed temporary mass vaccination clinics + mobile clinics

LTCFresidents & staff – commercialpharmacy partners + mobile clinics

Additional Considerations for Early Vaccination Planning

Jurisdictions should plan for real-time shipment of doses. Administrationsites ( during Phase 1) will not be required to store vaccine products beyondthe period of Vaccine B can be stored at 2–8 °C.

Vaccine will be free of cost, but administrationfees may not be reimbursablewhile a vaccine product is administered under an EUA

Given the challenging storage, handling, and administrationrequirements, early vaccination shouldfocus on

administrationsites that can reach prioritized populationswith as much throughputas possible.

Stability testing is ongoingfor Vaccine B; the storage and handling requirementspresented here may shift. The

requirementsin these scenarios are likely the strictest set of requirementsfor which planning is needed. Jurisdictions shouldconsider partneringwith the private sector and with local hospital systemsto providevaccine in

closest proximityto the prioritizedpopulations as possible, given limitationswith the product.

August 26, 2020

COVID- 19 VACCINATIONSCENARIOS FOR

JURISDICTIONAL PLANNING PHASE , Q4 2020

Scenario 3 : Vaccines A and B demonstrate sufficient efficacy / safety for EUA in 2020

Availability Assumptions

Candidate

Vaccine A

Vaccine B

End of Oct 2020

~ doses

Vaccineavailabilityby End of Nov 2020

doses

End of Dec 2020

doses

Notes

Ultra -cold (-70 ° C ), for large sites only Central distro capacity required (-20 °C )~ 1M doses 10M doses 15M doses

Total ~ doses doses 35–45M doses

Distribution , Storage, Handling, and Administration Assumptions

Vaccine SHIPMENT ON-SITE VACCINE STORAGE 3 separatelyacquiredcomponents (mixedon site) Frozen (-70 ° C C ) 1. Vaccine Must be used/ rechargedwithin 10 days

Directto site from manufacturer(on dry ice) Storage in shipping container OK ( replenish dry ice as Multidose vials (5 doses/ vial ) needed)

2. Diluent Thawedbut NOTreconstituted( 2–8 ° C ) Directto site from USG ( at roomtemperature) Must use within 24-48 hours

3. Ancillary supply kits Reconstituted ( room temperature) Direct to site from USG ( at room temperature) Must use within 6 hours

ORDERS ADMINISTRATION

Large quantities, to large administration sites only 2 - dose series ( 21 days between doses) Minimum order: 1,000 doses On -site mixing required ; reconstitute with diluent just prior

Maximum order : 5,000 doses to administration

Administer by intramuscular (IM ) injection PRIORITIZED POPULATIONS AND ANTICIPATED VACCINE ADMINISTRATION SITES

Health care professionals ( incl. LTCF staff) public health closed temporary mass vaccination clinics + potential for mobile clinics

Essential workers ( specifics TBA public health closed temporary mass vaccination clinics + potential for mobile clinics National Security populations public health closed temporary mass vaccination clinics + sites LTCF residents & staff potential for mobile clinics to facilities

VaccineB

SHIPMENT ON-SITE VACCINE STORAGE

2 separately shipped components Frozen (-20 ° C ) 1. Vaccine Storage in shipping container OK ( replenish dry ice as

To central distributor ( at -20 ° C) needed)

Multidose vials ( 10 doses/ vial) Refrigerated( 2–8 ° C )

2. Ancillary supply kits Must use within 7-14 days

Direct to site from USG (at roomtemperature) Roomtemperature Must use within 6 hours

ORDERS ADMINISTRATION

Central distribution capacity required 2 - dose series ( 28 days between doses )

Required by Dec 2020 No on-site mixing required Maintainedat -20 ° C Administer by intramuscular (IM ) injection

PRIORITIZED POPULATIONS AND ANTICIPATED VACCINE ADMINISTRATION SITES

Health care professionals ( incl. LTCF staff) – health care clinics + health care occupational health clinics + public health closed temporary mass vaccination clinics + mobile clinics

Essential workers (specifics TBA ) – hospital occupational health + hospital clinics + public health closed temporary mass vaccination clinics

August 26, 2020

COVID - 19 VACCINATION SCENARIOS FOR

JURISDICTIONAL PLANNING , Q4 2020

National Security populations + closed temporary mass vaccination clinics + mobile clinics LTCF residents & staff commercial pharmacy partners + mobile clinics

Additional Considerationsfor Early Vaccination Planning

Jurisdictions should plan for real-time shipment of doses.

Administrationsites ( during Phase 1) will not be required to store vaccine products beyondthe period of time Vaccine

A can be stored in the ultra- cold shipment box or Vaccine B can be stored at 2–8 °C. Vaccine will be free of cost, but administrationfees may not be reimbursablewhile a vaccine product is administered under an EUA.

Given the challenging storage, handling, and administrationrequirements, early vaccination should focus on

administrationsites that can reach prioritized populationswith as much throughputas possible.

Stability testing is ongoingfor Vaccine A and Vaccine B; the storage and handling requirementspresented here may

shift. The requirementsin these scenarios are likely the strictest set of requirementsfor which planningis .

Jurisdictions should consider partneringwith the private sector and with local hospital systems to providevaccine in closest proximityto the prioritized populations as possible, given the limitationswith the product. For example:

Vaccine A may be administeredthrough mobile clinics if multiple mobileclinics are plannedover a short periodof time to ensure high enough throughput.

August 26, 2020