COVID-19 Scientific Advisory Board Legislature Presentation May 21, - PowerPoint PPT Presentation

COVID-19 Scientific Advisory Board Legislature Presentation May 21, 2020 • President UMaine & UMM Joan Ferrini-Mundy, Ph.D., Chair • Vaccines/Antivirals - Melissa Maginnis, Ph.D., UMaine • Diagnostic Testing - Kristy Townsend, Ph.D., UMaine • Serology Testing/Immunity - Rob Wheeler, Ph.D., UMaine • Epidemiology and Contact Tracing - Sara Huston, Ph.D., USM • Transmission in the Environment/Surfaces - Caitlin Howell, Ph.D., UMaine

COVID-19 Vaccines and Therapeutic Development Clinical Trial Status Manufacturing Company Guidance for Availability Vaccines Partnered with AstraZeneca for ChAdOx1 nCov-19 Phase 1 - complete 400 million doses starting in 1 global development and (Viral Vector) • Phase 2 - March October, and capacity secured distribution • Phase 3 – May/summer (US) for 1 billion doses 2020-21 BARDA ($1b) funding to support Vaccines in development Partnered with Lonza, 10-year mRNA-1273 140 Partnership with Lonza enables Phase 1 - complete 2 agreement (RNA Vaccine) worldwide vaccine distribution of Phase 2 - approved May 6 • BARDA ($483m) funding to 1 billion doses/year . Phase 3 - July • support Leading candidates in INO-4800 4 Phase 1 - April 3 • clinical development Partnered with Richter-Helm (DNA Vaccine) Phase 2 - summer Indicates end of year availability • Biologics Phase 3 - fall • BNT162 program • Phase 1 - April 4 Emergency use or accelerated (RNA Vaccine) • Phase 2 - April Partnered with Pfizer approval starting in the fall • Phase 3 - TBD Antivirals Clinical Trial Status Clinical Trial Status Manufacturing Manufacturing Distribution Distribution Phase 1-3 – ongoing (5 trials) Building global consortium of • Remdesivir 1 May 1: FDA issued emergency manufacturers Providing 1.5 million free doses to (Nucleotide Inhibitor) use authorization for patients Aim to treat >1 million patients patients with severe disease by the end of 2020 Drugs in development 219 Convalescent plasma 2 Clinical trials • Hospital based Relies on donations from (anti-CoV Antibodies) Expanded access • FDA-registered donations recovered patients Emergency IND approval • Leading candidates 2 BARDA = Biomedical Advanced Research and Development Authority; IND – Investigational New Drug Melissa Maginnis

Primary Transmission Route: Aerosolized Droplets Containing Virus ● Virus can remain stable for up Coughing, Sneezing, and Speaking to 3 hours in air , up to 3 days on surfaces ● 25-80% infected individuals from non-healthcare settings show no symptoms ● Highest transmissibility likely occurs 2-3 days before symptoms show ● Increased population density increases probability of presence of virus. Thus, physical distancing and social distancing are key. ● Transmission appears to be increased with activities that require heavy or deep breathing (exercise/singing). However: Barriers, masks, and other engineered solutions slow the spread if used correctly with high compliance and in conjunction with distancing. Caitlin Howell

COVID-19 risk: Total virus exposure Asymptomatic period = # of virus particles x time Released Incubation period Symptomatic from y period Recover (2-14 days, mean: 11.5 days) period isolation No more 1 st exposure Presymptomatic Can be 10 symptoms to the virus period (1-3 days) days or longer (3 days) Symptomatic Develop period symptoms • Risk of transmission likely the highest before the onset of symptoms (Asymptomatic/presymptomatic period) Presymptomatic • # of virus particles: The more people in an period Asymptomatic period area, the higher the chance of virus being present, and in greater amounts • Time: The longer people remain together, the 1 st exposure higher the chance of to the virus • Properly fitted cloth masks reduce the number of virus particles entering shared air Without Mask With Mask Caitlin Howell

Current National Guidance on COVID-19 Management* Test Trace Isolate Rapid, high-throughput Contact tracing of COVID-19+ Isolation of COVID-19+ patients diagnostic testing for the (contacts within <6ft for >30 in infirmaries until healthy to entire community min are quarantined) return * Based on procedures that have been successful in “flattening the curve” around the globe Kristy Townsend

Testing for SARS-CoV-2 Infection: An important part of the arsenal to prevent spread of COVID-19 Period of positive diagnostic test (measures viral RNA by PCR or similar methods) Period of antibody detection by serology tests SARS-CoV-2 Infection • Active cases are detected, starting about 1wk before symptoms 2 Detects antibodies from previous infection (IgM & • • Workflow is well-validated, good sensitivity IgG detectable from 2-23d after symptomatic 1 ; Incubation Period: and specificity highest around wk 3 2 ) viral replication, • Can be cost-effective (high-throughput costs • Recent data indicate nearly 100% of cases develop • more, may have more false results) antibodies (within 19d of symptom onset) 1 shedding Latency • Positive tests are isolated until recovery Antibody+ patients could donate convalescent • (contagious) • After about 3wks since symptomatic, lose serum for treatment of active cases period Pre-symptomatic • PCR detection (below threshold for limit of Unclear if antibody presence indicates immunity • detection) 2 (research ongoing) RECOVERY 14+ days Variable days depending on disease progression, complications 3 days Kristy Townsend Timeline since initial infection Rob Wheeler

Preventing Spread: Isolate Cases, Quarantine Contacts Contact Tracing Source: A Coordinated, National Approach to Scaling Public Health Capacity for Contact Tracing and Disease Investigation, Association of State & Territorial Health Officers; and Resolve to Save Lives Sara Huston

Transmission, Mitigation, and Safety in the Built Environment Caitlin Howell, PhD Assistant Professor of Biomedical Engineering Movement of virus-containing Role of surfaces in person- Other potential routes of droplets in the environment to-person transfer of virus infection and opportunities for detection Dietz et al. 2020 mSystems 5: e00245-20 • Li et al. 2020 medRxiv Infectious virus found recently • Speaking can generate aerosols 1 Virus can land on surfaces and be • • found in feces 5 , viral traces in • Masks are effective when used re-aerosolized 4 toilet areas 4 correctly and compliance is high 2,3 Virus traces found on shoes as • Wastewater monitoring can • Good ventilation is critical; well as handles, chairs, etc. 4 • assist in early identification of recirculation contributes to spread 4 Regular disinfection is effective 4 • outbreaks 6

COVID-19 Scientific Advisory Board Contact Information: • Caitlin Howell: caitlin.howell@maine.edu • Sara Huston: sara.huston@maine.edu • Melissa Maginnis: melissa.maginnis@maine.edu • Kristy Townsend: kristy.townsend@maine.edu • Robert Wheeler: robert.wheeler1@maine.edu