Breakthroughs in Vaccines & Therapies for the Senior Living Community by Argentum

Breakthroughs in Vaccines & Therapies for the Senior Living Community

Speaker

John Schulte Vice President, Quality Improvement Argentum

Presentation Overview        

What Trade Associations Do COVID-19 Guidance, Webinars, Issues COVID-19 Status, Variants Vaccination Status Vaccine Status, Supply SARS-CoV-2 Viral Life Cycle Immune System Treatments: Convalescent Plasma, Monoclonal Antibodies 3

What Trade Associations Do  We help the industry perform well, in terms of serving the needs of residents and other stakeholders, and operating profitably.  Trade associations help companies achieve goals collectively that would be too difficult, expensive, or impossible to do individually.

Argentum’s COVID-19 Guidance • Argentum Guidance: COVID-19 Testing (March 2020; Updated April 2020) • Guidance: COVID-19 Reporting Positive Cases and Leadership Communications (April 2020) • White Paper: “The Need for a Smart Testing Strategy” (May 2020) • Community Access and Infection Control (March 2020, November 2020) • Argentum Guidance for Managing COVID-19 Restrictions (June 2020) • Essential Caregiver Toolkit (October 2020) • Argentum Guidance for Infection Prevention and Control (November 2020) • Resident Engagement and Socialization (February 2021)

Argentum’s COVID-19 Webinars • • • • • • • • • • • • •

In-community Testing Primer (April 2020) Staffing Solutions During COVID-19 (April 2020) Best Practices for Memory Care Residents (May 2020) Crisis Communications During COVID-19 (May 2020) Managing COVID Restrictions (June 2020) HR Considerations as States Re-open (June 2020) Preparing for COVID-19’s Long-Term Business Impact (June 2020) The Regulatory Aftermath of COVID-19 (July 2020) Eligibility and Application for Phase 3 Distribution from the CARES Act Provider Relief Fund (October 2020) Testing Update (October 2020) Complying with Terms and Conditions of HHS Provider Relief Fund Payments (November 2020) Vaccine Readiness Briefing (December 14, 2020) Provider Relief Fund Reporting Update (February 2021)

Argentum’s COVID-19 Issues • • • • • • • • • • • • • • • • • • • • •

Visitation Community Screening Protocols Resident Move-ins and Re-entry Protocols Physical Distancing Leadership Communications Reliable Access to Verified Supplies (PPE, Disinfectants) Access to Testing Access to POC Testing and CLIA Certificates of Waiver Contact Tracing Telehealth Data Management Vaccination: Long-term Care Facilities PPP Vaccine Safety Vaccine Roll-out, Mandates Briefing: Monoclonal Antibody Treatments On-going Vaccination After LTCPPP PPE: Decontamination and Reuse OSHA: Workplace Safety Liability Staffing Issues (Working in multiple buildings, caregivers needing to stay home with children who are out of school, wages/hero pay, leave policies…) Stress/Burnout/Fatigue/Exhaustion/Grief

Argentum Coronavirus Toolkit  Resources: Argentum Coronavirus Toolkit       

Guidance Webinars Blog Vaccine News and Resources HHS Funding Facts Advocacy Letters More

U.S. COVID-19 Status U.S. COVID-19 Status (As of February 21, 2021)  27,882,557 total cases (including 71,214 new cases)  Average daily cases (past seven days): 2 cases per 100 people  Total Deaths: 496,112 Source: United States COVID-19 Cases and Deaths by State 9

COVID-19 Status: Variants As of February 21, 2021  B.1.1.7 (U.K. variant): 1,661 reported cases, 44 states  B.1.351 (South African variant): 22 reported cases, 10 states  P.1 (Brazilian variant): 5 reported cases, 4 states

Source: US COVID-19 Cases Caused by Variants (Note: These are NOT comprehensive counts of all U.S. cases; these figures reflect minimal sequencing of all U.S. cases.) 10

COVID-19 Variants  What to monitor regarding variants: “TILT”  Is the variant more Transmissible?  Is the variant better able to evade the Immune system, either immunity built up from previous infection, or from vaccines?  Is the variant more Lethal?  Is the variant able to escape diagnostic Tests?

COVID-19 Variants  The U.K. began sequencing virus samples in March 2020; there were 84 cases of COVID-19 in the U.K.  280,000 samples sequenced as of last week – about 5% to 10% of all cases in the U.K.     

Over the past year, COVID-19 mutating every other week U.K. variant 50% more transmissible than previous strain U.K. variant about 35% more lethal U.K. variant is able to dodge some of the diagnostic tests U.K. variant accounts for 92% of cases in the U.K. and is found in 82 countries

Source: COVID-19 Variants: What You Need To Know (U.S. Chamber of Commerce: Dr. Sharon Peacock, Executive Director and Chair, U.K. Genomics Consortium – February 17, 2021)

U.K. VARIANT

U.S. COVID-19 Total Vaccination Status (February 21, 2021)  75.2 million doses delivered  63.1 million doses administered  43.6 million people receiving one or more doses  18.9 million people receiving two doses

Source: COVID-19 Vaccinations in the United States

 Vaccine-eligible population: There are an estimated 275-280 million U.S. citizens aged 16 and older. (Statista.com; data from July 2019) 14

U.S. COVID-19 LTC Pharmacy Partnership Program Vaccinations 

6.5 million doses administered through the LTC PPP  

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4.4 million people receiving one or more doses 2.1 million people receiving two doses

The first state (KY) started administering doses 12/21/2020. Some states didn’t start administering vaccines through the LTC PPP until late-January 2021. (Wisconsin started January 25, 2021) Approximately 8.5% of all doses delivered in the U.S. are being administered through the LTC PPP. Of the doses administered in the LTC sector:   

46.5% are being administered to residents 32.4% are being administered to staff 20.5% are being administered under the “non-reported” category

Source: COVID-19 Vaccinations in the United States (As of February 21, 2021) (Vaccine-eligible population: There are approximately 260 million U.S. citizens aged 16 and older, and 290 million aged 18 and older)

U.S. COVID-19 “AL and Other LTC” Vaccination Status – CVS  CVS has administered 1.8 million doses of vaccine to 37,958 facilities across the U.S.  First clinics have been completed for 42 out of the 54 states/territories/other jurisdictions served by CVS. (Most other states are in the 95% and up completion range.)  Second clinics have been completed in six states/territories.  No third clinics have been reported.

Source: CVS Health: COVID-19 vaccination data (As of February 19, 2021)

U.S. COVID-19 “AL and Other LTC” Vaccination Status – Walgreens  Walgreens has administered 1.2 million doses of vaccine to 20,401 facilities across the U.S.  First clinics have been completed for all 52 states/territories/other jurisdictions served by CVS.  Second clinics have been completed in seven states/territories.  No third clinics have been reported. Source: Walgreens LTCF Vaccination Efforts Breakdown (As of February 18, 2021) 17

U.S. COVID-19 AL and Other LTC Vaccination Status  Combined, Walgreens and CVS have administered approximately 3 million doses of vaccine to over 58,000 assisted living and other long-term communities (e.g., group homes), excluding SNFs. Sources: CVS Health COVID-19 vaccination data Walgreens LTCF Vaccination Efforts Breakdown (As of February 19-18, 2021) 18

VACCINE STATUS Pfizer-BioNTech (mRNA vaccine)  EUA issued December 11, 2020  95% efficacy Moderna (mRNA vaccine)  EUA issued December 18, 2020  94% efficacy

VACCINE STATUS Johnson & Johnson (Viral-vectored vaccine)  Phase 3 trial finalized Feb. 2021  FDA review of J&J application Friday (Feb. 26)  72% efficacy in U.S. trials (66% effective overall)  85% effective in preventing serious cases of COVID-19  100% effective at preventing death due to COVID-19

 Single-dose

VACCINE STATUS Novavax NVX-CoV2373 (S-protein-based vaccine)  Phase 3 trial completed in U.K.  89.3% efficacy, with over 50% of cases attributable to U.K. variant  Combined U.S./Mexico Phase 3 trial underway, with over 20,000 participants (target 30,000)  EUA status targeted for April 2021

Source: Company Press Release (January 28, 2021) 21

VACCINE STATUS Oxford-AstraZeneca (Viral-vectored vaccine)  Phase 3 trial in progress  Preliminary data show 82% efficacy when doses  EUA application targeted for March 2021

Source: NY Times (February 3, 2021) 22

U.S. VACCINE SUPPLY  Pfizer: 300 million doses  200 million doses by end of Q2 2021

 Moderna: 300 million doses  100 million doses by end of Q1 2021  Second 100 million doses by end of Q2 2021  Final 100 million doses by end of July 2021

Source: MarketWatch (Feb. 12, Feb. 11, 2021) 23

U.S. VACCINE SUPPLY  Johnson & Johnson:

 100 million single-doses (end of June 2021)

 Novavax:

 110 million doses by end of Q2 2021

 AstraZeneca:

 Contracted for 300 million doses (no timeline given)

Source: After a Rocky Start, Novavax Vaccine Could Be Here by Summer (NY Times, 2/3/2021)

SARS CoV-2 Viral Life Cycle How the Virus Works:  Virus attaches to human cell (e.g., lungs)  Virus uses cell to replicate, creating more virus, shredding cell in the process  If enough cells destroyed, permanent damage (primarily lungs) and inflammation

How Immune System Works 

Neutralizing antibodies in the immune system identify and bind the virus, keeping it out of the cell, stopping replication from the start

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Certain cells break up the virus and use the fragments to teach other cells to recognize and attack virus.

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Cells are also taught how to make antibodies that bind the virus.  Polyclonal antibodies = convalescent plasma (can bind many pathogens)  Monoclonal antibodies = antibodies focused on a specific pathogen – very well targeted – produced in large quantities (high titer), infused into infected patients to bind the virus and treat infection  Monoclonal antibodies are like convalescent plasma on steroids!

 Source: Use of Neutralizing Monoclonal Antibodies as a Treatment for COVID-19 (American College of Medical Toxicology, Peter Chen, MD; Professor of

Medicine and Biomedical Sciences; Director, Division of Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center, Los Angeles, CA – February 3, 2021) 26

COVID-19 Treatments: Convalescent Plasma  FDA Emergency Use Authorization issued for Convalescent Plasma August 23, 2020.  Updated EUA issued February 11, 2021

 Uses antibodies from a COVID survivor to help treat infected patients  Only for hospitalized patients

 Source: FDA: Recommendations for Investigational COVID-19 Convalescent Plasma 27

COVID-19 Treatments: Monoclonal Antibodies (CmAb)  EUA issued for Bamlanivimab (Eli Lilly) November 9, 2020  EUA issued for Casirivimab and Imdevimab (Regeneron) November 21, 2020  Authorized for treatment of mild-to-moderate, non-hospitalized patients who are at high risk for progressing to severe COVID-19 or hospitalization

 Prioritized for use in seniors, immuno-compromised individuals, others who are at-risk

COVID-19 Treatments: Monoclonal Antibodies (CmAb)  Several early trial studies showed reduced hospitalization/Emergency Department visits.  5.8% of placebo group (9 of 152) hospitalized/ED visit  .9% of treated group (1 of 109) hospitalized/ED visit

 Blaze-1 Phase 3 Study (high-risk patients)  7% of placebo group (36 of 517) hospitalized or death  2.1% of treated group (11 of 518) hospitalized or death

 This represents a 70% drop in hospitalization or death 29

COVID-19 Treatments: Monoclonal Antibodies (CmAb)  Severe adverse events and adverse events were comparable among the placebo and treatment groups; safety is fine  The Blaze-1 study is not yet final as of February 3, 2021. Source: Use of Neutralizing Monoclonal Antibodies as a Treatment for COVID-19 (American College of Medical Toxicology,

Peter Chen, MD; Professor of Medicine and Biomedical Sciences; Director, Division of Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center, Los Angeles, CA – February 3, 2021)

COVID-19 Treatments: Monoclonal Antibodies (CmAb) Issues and considerations with CmAb treatments for assisted living:  Access to medications  Educating/generating awareness among primary care physicians  Infusion treatments require training, expertise  Time for administering treatment, monitoring  Billing for reimbursement  Regulatory limitations on AL scope 31

COVID-19 Treatments: Monoclonal Antibodies (CmAb) HHS: Special Projects for Equitable and Efficient Distribution (SPEED) program  Locate a third-party home infusion through the National Home Infusion Association’s Bamlanivimab Pilot Provider List  Use NHIA’s map locator to find a nearby provider  SPEED program is committed to ensuring access to treatments specifically for LTC facilities, including SNF and assisted living communities  No charge for treatments 32

COVID-19 Treatments: Monoclonal Antibodies (CmAb) Sample protocol  Physician’s order sent to pharmacy  Pharmacy vets patient per EUA  Infusion provider:  Secures mAb treatments  Secures consent for the treatment  Administers the treatment in the community using the infusion provider’s PPE  Monitors the infusion recipient for one hour following treatment, per protocol  Addresses any adverse reactions to the treatment using an emergency kit the infusion provider brings to the community  Handles billing and reimbursement following treatment 33

Audience Q&A

John Schulte Vice President, Quality Improvement Argentum