My Mask Protects Us Both

• CDC published updated analysis regarding the role of mask use in protecting the wearer. The official CDC guidance continues to emphasize the value of masks as source control by filtering and slowing forward momentum of particles not captured

• Updated analysis indicates that masks can provide protection for wearer as well, including ability to o Filter 50-70% of fine droplets and particles less than 10 microns

• Filtration effect varied between masks and mask types, with multi-layer masks constructed with more densely woven material performing better than single-layer masks made from lower thread count fabrico Studies evaluated various mask materials

• Synthetic (eg, polypropylene which generate ‘triboelectric’ charge)• Natural materials (eg, silk which repel most droplets)

ADA Reasonable Modifications

• Wearing masks is important, but not everyone can wear one safely

o Medical, mental health, or developmental disabilities

• Mask mandates do not not override consideration of reasonable modifications required by Americans with Disabilities Act (ADA)o The ADA reasonable modification of practices and procedures

requirement remains applicable to healthcare providers

• Individuals are not required to disclose their disabilityo “Requiring proof of a disability would amount to discrimination or

exclusion from having equal access to routine goods and services” ("Face Coverings and the ADA")

• ADA does not provide protection for people without disabilities

Face Coverings and the ADA: Implications for Title III

Disability

• Data dashboard update

• FAQ on relationships

Additional Resources on ADA and COVID-19

• https://www.ada.gov/

• Webinar: Face Coverings and the ADA: Implications for Title III

• Disability Issues Brief: ADA and Facemask Policies

• ADA, Disability & COVID-19 Resources

• Safeguard Against Disability Discrimination During COVID-19

Nov 10, 2020: Monoclonal Ab EUA

• LY-CoV555 (bamlanivimab; Eli Lilly) received EUA for one-time 700 mg IV treatment of outpatients

• In Phase 2 study, 700mg dose did not result in a decline in viral load in outpatients over 11 dayso 2,800 mg dose resulted in ~3 fold reduction in viral load

o Any antibody dose had lower symptom severity as well as lower hospitalization rates and ED visits (1.7%) than placebo (6%)

o Additional unpublished data re 700mg dose?

EUA Guidance for Bamlanivimab

1. >12 years

2. >40kg (88 pounds)

3. Test positive for SARS-CoV-2

4. Currently experiencing mild or moderate COVID-19 disease, but not currently hospitalizedo Should not be administered to individuals who are

receiving supplemental oxygen therapy (ie, high-flow oxygen or mechanical ventilation), as this could increase the risk of “worse clinical outcomes.”; AND

5. High risk for severe COVID-19 disease

Bamlanivimab Availability

• Biomedical Advanced Research and Development Authority (BARDA) pre-purchased 300k doses from Eli Lilly, as part of OWSo US$375 million, with option of 650k more doses through end

of 2021 at an additional cost of US$812.5 milliono 100 vials coming to NH

• Availability for outpatient infusion centers and hospitals

• NH Medicaid and Medicare (presumably private insurers) will likely pay for infusion costs and Bamlanivimab at no patient cost share for covered personso Drug cost only be reimbursed if the healthcare providers had

to purchase product

Phase 3 in Hospitalized Patients Halted

• NIH announcement halted RDV+Ly-CoV555 trial because DSMB reviewed data on 326 patients on Oct 26th and concluded there was a “low likelihood that the intervention would be of clinical value” for hospitalized patientso Note 7g of Ly-CoV555—10 times dose in FDA EUA

application for less ill outpatients

• So possible benefit among outpatients, but longer course of infection and severity among hospitalized patients reduces likelihood of benefit for the treatment

BLAZE-1: Combination mAbs in Outpts

• RCT Phase 2 study of LY-CoV555 (bamlanivimab) + LY-CoV016 (etesevimab)o Both neutralizing monoclonal antibodies against spike

protein

• In mild-to-moderate recently diagnosed outpatientso 112 treated, 156 placebo

o 2,800 mg of each antibody together

o 5.6 fold suppression of viral load at day 11 compared to placebo

o Hospitalization and ED visits was lower for patients treated with combination therapy (0.9%) versus a placebo (5.8%)

Most Advanced US Candidates

Vaccine Platform Schedule Ph 3 Updates

ModernaNIH

mRNA 2-doses, 21d-20C

July 27

July: Patent dispute lostOct 23: completed ph3Nov 11 endpointsEUA imminent

PfizerBioNTechFosun Pharma

mRNA 2-doses, 28d-70C

July 27

Sept 12: expanded to 43kInterim analysis Nov 9 2020EUA subm 3rd week Nov

Johnson and Johnson

Ad26 (~Ebola)

1-dose Sept Oct 12 pause for AEOct 23 restarted

AstraZenecaOxford

ChadOx1 2-doses, 28d

July Sept 6 pause for AEOct 23 restarted in US

Novavax Protein subunit nanotech

2-dose, 21d Sept UKNov US

Early 2021 results

Pfizer Interim Analysis 11/9/2020

• 43,538 participants of racial and ethnic diversity

o 42% of international sites

o 30% of US sites

• Interim analysis shows 94 cases (of sample size target 164) occurred

o <10% of cases among vaccine recipients

• 90% protection achieved

• 7d after second dose

• 28d after first dose

• EUA application allowedo Half of recipients are two months beyond

second dose

o 3rd week of November