Vaccine Advisory Committee December 15, 2020 Agenda

 COVID-19 Vaccine Response Director Updates  Pfizer Vaccine Safety & Efficacy Data  Vaccine Science Advisory Workgroup Update  Provider Education Update  VAC Discussion  Public Comment

Washington State Department of Health | 2 COVID-19 Vaccine Response Director Updates

SHEANNE ALLEN • Washington’s allocation of the Pfizer vaccine is 62,400 doses for the first week. • The doses are going to reach 38 facilities in 29 VACCINE is counties, 1 pharmacy serving longterm care facilities across the state, 1 tribal nations, and 1 HERE!!! urban Indian health facility. • Vaccine orders will arrive in a staggered fashion during week on Monday, Tuesday. • We will continue to get more vaccine weekly throughout the rest of December, and will be able to reach all counties and many more facilities.

Washington State Department of Health | 4 Projected Timeline

Pfizer Vaccine Moderna Vaccine ➢ November 20 - Pfizer submits Emergency Use Authorization ➢ November 30 - Moderna submits Emergency Use Authorization (EUA) request (EUA) request ➢ December 10 - FDA’s Vaccines and Related Biological ➢ December 17 - FDA’s Vaccines and Related Biological Products Products Advisory Committee Advisory Committee Review ➢ December 11 – ACIP meeting with Pfizer data/GRADE ➢ December 18 – ACIP meeting with Moderna data/GRADE presented presented ➢ December 12 – Possible FDA EUA decision ➢ December 19 – Possible FDA EUA decision ➢ December 13 – If EUA issued, ACIP meeting with Pfizer vote ➢ December 20 – If EUA issued, then ACIP meeting with Moderna vote, allocation of phase 1b/c vote ➢ December 14 – MMWR publication for Pfizer vaccine. GRADE/EtR tables and clinical considerations published. ➢ December 21 – Moderna MMWR published; Allocation of Phase 1b/c MMWR published. ➢ December 14-15 – Western States Pact Scientific Safety Review ➢ December 21-22 - Western States Pact Scientific Safety Review ➢ December 15th – Vaccine distribution to early ship sites & and ordering opens for others ➢ December 22 – Vaccine allocation availability for ordering and distribution

Washington State Department of Health | 5 Vaccine Allocation Projections

• Expected estimates for Weekly Pfizer Moderna planning purposes Allocation doses doses • Regular weekly shipments December 62,400 -- should begin in January 15 December 74,100 128,000 22 December 85,800 55,800 29

Washington State Department of Health | 6 Provider Enrollment via Department of Health

• As of 12/15/2020, 272 facilities enrolled

• Providers complete the provider inquiry form. We follow-up with organizations as soon as possible. Use the COVID-19 Provider Enrollment Guide (PDF) to help through the enrollment process.

• Each facility enrolling will need to complete a survey. One survey per facility (i.e., location where vaccine will be shipped)

https://www.doh.wa.gov/Emergencies/COVID19/HealthcareProviders/ VaccineInformationforHealthcareProviders

Washington State Department of Health | 7 12/1/2020 ACIP Meeting Discussion

Washington State Department of Health | 8 • High-risk workers in health care settings • High-risk first responders • Residents and staff of nursing homes, assisted living Phase 1A facilities, and other community-based, congregate living settings where most individuals over 65 years of COVID-19 age are receiving care, supervision, or assistance Vaccine Allocation • ACIP vote on Dec 20th for Phase 1b & c

Guidance • Link: WA State COVID-19 Vaccine Allocation Guidance for Phase 1A

Washington State Department of Health | 9 • To protect highest risk exposure • To maintain medical and surgical surge capacity Guiding • To protect most vulnerable Principles • To reduce hospitalizations, severe morbidity, and mortality

Washington State Department of Health | 10 Phase 1A Objectives • Protect those at highest risk of exposure Phase 1A Example Workers • Maintain medical surge response capacity

• Workers in sites where direct patient care is being delivered to confirmed or suspected COVID-19 patients • Example settings: ICU; emergency department; home; isolation/quarantine facility • Roles: healthcare providers; tech; CHW; facility staff; security; non-remote translators; high risk aerosolization procedures • Workers exposed to/handling potentially SARS-CoV-2 containing specimens & COVID-19 testing staff • First responders at highest risk of exposure to suspected or confirmed COVID-19 patients via high public exposure and procedures • Frontline emergency workers providing care, transport/ambulatory support, and oversight of any agency (fire, ambulance, hospital) • Workers with elevated risk of acquisition/transmission with populations at higher risk of mortality or severe morbidity • Examples: staff at long-term care facilities; workers with patients undergoing chemotherapy, dialysis, etc.; home health aides/home care aides/caregivers/companions • Workers administering vaccines for phase 1a, 1b, and 1c populations Washington State Department of Health | 11 ACIP Proposed Phase Sequence There are many unknowns requiring an adaptive approach

TOPIC KNOWNS UNKNOWNS - December supply projections Supply - Post-December supply projections - Vaccine presentation ACIP - Critical workers likely to be Ph 1b - Do they re-order or combine? guidance - 65+ and co-morbid likely to be Ph1a - Do they stratify? - Will ACIP recommend above a certain age (80)? Safety - Side effects - Will certain co-morbidities be excluded? - Will it vary by vaccine? - How many in Phase 1a will want the vaccine? Uptake - How many in Phase 1b/c will want the vaccine? Confirming - How do we confirm eligibility for different groups that eligibility cannot be verified? - # of people over 65 - # of people with 1 co-morbidity Size - Some worker groups - # of people with 2 co-morbidities

Washington State Department of Health | 13 Population Size Estimates POPULATION GROUP SIZE ESTIMATE NOTES High-risk workers in healthcare settings 350,000 (reduce LTCF staff) Tiberius – 466,000; PAVE Tool – 350,000 High risk first responders 30,000 Tiberius – 58,000; PAVE Tool – 25,000 Residents and staff of nursing homes, 80,000 (Phase A) assisted living facilities, and other 100,000 (Phase B) community-based, congregate living settings, etc. People ≥ 65 years of age 1,000,000

People with comorbid and underlying Consulting with experts to refine figure. conditions that put them at significantly 800,000 (if 2+ comorbid) Total population with relevant comorbidities and underlying conditions is estimated at over 4 million but higher risk there is overlap: (data source) Note: many (50%) of these ● Cancer: 1,000,000 (State cancer profiles); 40,000 new cases/year are people over 65 years of ● Chronic kidney disease: 160,000 (DOH) age so significant overlap ● COPD: 300,000 (DOH) between the two ● Immunocompromised from solid organ transport/yr: 200 (UNOS) ● Obesity: 1,700,000 (DOH) ● Serious heart condition: 330,000 (DOH) ● Sickle cell disease: 2,000 (CDC) ● Type 2 diabetes: 565,000 (DOH) ● Smoking (TBD) Highest risk critical workers 170,000 Consulting with agencies to refine estimate. Population likely to include some portion of: ● Agriculture support services: 34,000 ● Meat processing/slaughtering: 5,500 ● Correction facilities: 6,700 ● Workers in childcare setting: 25,000 Washington State Department of Health | 14 WA GUIDANCE PROJECTED ROLL-OUT

300k

200k

150k

100k

First per doses week First 50k 1A 1B/C* 2 3 4

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33

* Assumptions: lower range Phase 1B/C scenario; 150k/week doses available but some estimates suggest 180k/week

Washington State Department of Health | 15 Allocation factors/considerations

• Pro rata allocation against estimated distribution of healthcare workers by county • Estimated number of people can vaccinate in first two weeks • Ensuring equitable/geographic distribution • Implementation considerations (e.g., who has vaccine plan completed, ULTF capacity and refrigeration capacity for thawing vaccine, timing of events those using thermal shipper, willingness to serve outside facility/system) • Emerging data regarding vaccines (e.g., safety for different populations)

Washington State Department of Health | 16 Pfizer-BioNTech COVID-19 Vaccine

KATHY BAY DNP, RN, CENP Source: Mbaeyi, S, 12/12/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/12/2020. Washington State Department of Health | 18 Source: Mbaeyi, S, 12/12/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/12/2020.

Washington State Department of Health | 19 Source: Gruber, W., 12/11/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/13/2020.

Washington State Department of Health | 20 Source: Gruber, W., 12/11/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/13/2020

Washington State Department of Health | 21 Source: Gruber, W., 12/11/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/13/2020

Washington State Department of Health | 22 Source: Gruber, W., 12/11/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/13/2020

Washington State Department of Health | 23 Source: Gruber, W., 12/11/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/13/2020

Washington State Department of Health | 24 Source: Gruber, W., 12/11/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/13/2020

Washington State Department of Health | 25 Source: Gruber, W., 12/11/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/13/2020

Washington State Department of Health | 26 ACIP Review of Evidence

Source: Oliver, S, 12/12/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/12/2020. Washington State Department of Health | 27 ACIP Review of Evidence

Source: Oliver, S, 12/12/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/12/2020.

Washington State Department of Health | 28 Side Effects o The most common side effects of the vaccine are similar to those of some routine vaccines, such as a sore arm, fatigue, headache, and muscle pain. Frequency of these effects in people younger than 55 include: ♦About 80 percent of people reported pain at injection site ♦About half of the people reported fatigue and headache ♦Less than one-third of people (30 percent) reported muscle pain. o Most side effects occur within two days of getting the vaccine and last about a day. o Side effects are more common among people 55 years or older than among those younger than 55. o Side effects are more common after the second dose than the first dose.

Washington State Department of Health | 29 Source: Mbaeyi, S, 12/12/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/12/2020.

Washington State Department of Health | 30 Source: Mbaeyi, S, 12/12/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/12/2020. Washington State Department of Health | 31 Washington State Department of Health | 32 Source: Mbaeyi, S, 12/12/2020; Advisory Committee on Immunization Practice meetings available: https://www.cdc.gov/vaccines/acip/meetings/index.html. Accessed 12/12/2020. Washington State Department of Health | 33 Washington State Department of Health | 34 Pfizer BioNTech Vaccine Storage and Handling

Washington State Department of Health | 35 Washington State Department of Health | 36 Provider Resources

  Department of Health Toolkits • Enrolling as a COVID vaccine provider • Frequently Asked Questions • Providers who can order and administer vaccines • Coming soon • Link to sample consent • Link to standing orders

Washington State Department of Health | 45 Washington State Department of Health | 46 Washington State Department of Health | 47 CDC Provider Education Resources

New Different COVID-19 Vaccines | CDC Understanding COVID-19 mRNA Vaccines

Updated Ensuring COVID-19 Vaccines Work | CDC Facts about COVID-19 Vaccines How CDC Is Making COVID-19 Vaccine Recommendations | CDC Vaccine Education and Training for Healthcare Professionals | CDC COVID-19 Vaccination Resources

Washington State Department of Health | 48 Science Advisory Workgroup

Washington State Department of Health | 49 Science Advisory Workgroup

• Timely input on provider education and tools needed • Development of science document for reference related to vaccine platforms • Future work • Review/discussion of post vaccination reported events • Continued development of vaccine tools

Washington State Department of Health | 50 Discussion Questions oWhat additional information do providers need? oWhat feedback do you have on our current provider sites/access points for vaccine? oBarriers to provider participation? What are provider challenges with participating?

Washington State Department of Health | 51 Resources

• CDC toolkit for healthcare organizations: https://www.cdc.gov/vaccines/covid- 19/health0systems-communication-tooklit.html. • FDA COVID-19 Information: https://www.fda.gov/emergency-preparedness-and- response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19. • FDA EUA Guidance: https://www.fda.gov/emergency-preparedness-and-response/mcm- legal-regulatory-and-policy-framework/emergency-use-authorization-covid-19euas. • Pfizer BioNTech Emergency Use Authorization: https://www.fda.gov/media/144414/download. • WashingtonState Department of Health ordering and administering provider list: https://www.doh.wa.gov/Portals/1/Documents/Pubs/698-001- ProvidersAuthorizedVaccineAdministration.pdf.

Washington State Department of Health | 52 Communication & Updates

COVID Vaccine Email ■[email protected]

Washington State Department of Health | 53 To request this document in another format, call 1-800-525-0127. Deaf or hard of hearing customers, please call 711 (Washington Relay) or email [email protected].