A Coronavirus Update with Leading Health Experts and Business Leaders

• Call Context: Hosted March 20, 2020, by Goldman Sachs' Sharmeen Mosavar-Rahmani; featured CEOs from Roche and Quest Diagnostics, Dr. Leonard Schleifer (Regeneron), Stefan Bancel (Moderna), Dr. Tebas (Inovio), Dr. Slavin (Mass General), and Dr. Bloom (Epidemiology).
• Global Case Fatality Rates (CFR): Current estimates vary significantly by region: Wuhan (4.99%), China excluding Hubei (0.88%), Italy (8.3%), and the U.S. (1.17%).
• Testing Limitations: Early CDC testing faced inconclusive results; the U.S. initially lacked capacity compared to nations like South Korea, with only ~100,000 tests conducted in the U.K. at the time of the call.

Diagnostic & Testing Capacity

• Roche Diagnostics:
  • Launched "research use only" assays in January, later securing CE labeling and FDA Emergency Use Authorization (EUA) for the Cobas 6800/8800 systems.
  • Development timeline for assay deployment compressed from standard 2–3 years to six weeks.
  • Production of reagents is ramping up but remains a bottleneck due to linear industry expansion against exponential demand growth.
  • Platforms are open, allowing the use of Laboratory Developed Tests (LDTs) and primers from various vendors.
• Quest Diagnostics:
  • Moved from ~0 tests/day on March 1 to ~20,000 tests/day by March 20, 2020 (approx. 150,000 per week).
  • Collaborates with Roche on automated platforms and with Verily (Alphabet/Google) on the West Coast for specimen collection.
  • Identified dual bottlenecks: laboratory assay capacity (increasing) and specimen collection logistics (swabs, PPE, and trained personnel).
  • Partnered with federal agencies and retailers (CVS, Walmart, Target) to establish specimen collection sites.
• Industry Outlook:
  • Demand is described as "almost unlimited" globally.
  • Capacity is projected to reach half-demand within a week and meet demand within two to three weeks, assuming supply chain constraints are resolved.
  • Serologic testing (to identify past infection) is highlighted as a critical, yet pending, need to facilitate economic re-entry.

Therapeutics

• Regeneron Strategy (Dr. Schleifer):
  • Kevzara (Tocilizumab): An IL-6 blocker (previously approved for rheumatoid arthritis); currently enrolling patients in trials to address viral-induced lung inflammation.
  • Monoclonal Antibody Cocktail: Leveraging a proprietary "humanized mouse" platform; aims to begin Phase I trials in June and scale production by late summer.
  • Ebola Precedent: Cites 90% survival protection in Ebola trials when administered early, serving as a optimistic model for COVID-19.
  • Stockpiling: Manufacturing Kevzara and monoclonal antibodies "at risk" to ensure immediate availability if trials succeed.
• Skepticism on Existing Drugs:
  • Cautioned against unproven claims regarding chloroquine/hydroxychloroquine or existing antibiotics; emphasizes the need for controlled data over anecdotal evidence.
  • Noted the failure of the lopinavir/ritonavir combination in previous trials.
• Production Logistics:
  • Kevzara is expected to be available for large-scale commercial use without chronic treatment requirements (single dose potentially sufficient).
  • Industry coordination is expected to scale production of other potential agents (e.g., Roche's Actemra, Eli Lilly, Biogen).

Vaccine Development

• Moderna (mRNA Platform):
  • Timeline: Designed vaccine sequence on Jan 13; dosed first Phase I participant on Feb 23 (63 days).
  • Phase I Status: Started March 16, 2020; primary endpoint is safety (data expected in ~2 months); secondary endpoints (antibody titers) expected 1–2 months post-safety.
  • Phase II Plan: To commence immediately following Phase I safety data, including elderly cohorts (45 subjects in Phase I, expanding to hundreds in Phase II).
  • Targeted Availability:
    • Fall 2020: Potential Emergency Use Authorization (EUA) to vaccinate healthcare workers and essential personnel (millions of vials/month capacity planned).
    • Fall 2021: Goal for full commercial approval and mass vaccination of high-risk populations.
  • Agility: mRNA platform allows rapid adaptation to viral mutations (potential 30-day timeline from sequence to GMP product) and manufacturing scalability (24/7 operations).
• Inovio (DNA Platform):
  • Utilizes DNA vaccine technology with a similar timeline to mRNA; first Phase I doses anticipated in the first week of April.
  • Aims to demonstrate safety and immunogenicity within 2–3 months; efficacy trials require longer follow-up (12–18 months).
• Dr. Tebas (NIH/Inovio):
  • Current natural immunity durability is unknown; historical data on SARS/MERS suggests durable immunity, but influenza-like annual reinfection is also possible.
  • Viral mutation monitoring is active; so far, mutations have not impacted the Spike protein targeted by current vaccines.

Healthcare System Preparedness

• Massachusetts General Hospital (Dr. Slavin):
  • Current Status: 6 confirmed COVID-19 cases; 109 patients admitted for respiratory illness awaiting test results; occupancy dropped from >90% to 70% due to elective cancellations.
  • Telemedicine Adoption: 15% of outpatient visits converted to telemedicine to protect vulnerable populations and staff.
  • Critical Shortages: National PPE stockpile (~12.5 million masks) is insufficient for estimated needs (3.5 billion masks); urges full mobilization under the Defense Production Act.
  • Turnaround Time: Lab testing delays (24–48 hours) force hospitals to treat unconfirmed patients as infectious, depleting PPE reserves.
  • Workforce Safety: Exploring temporary housing for staff (e.g., hotels) to prevent community transmission, though no full centralized quarantine model exists yet.
  • 3D Printing: Receiving hundreds of offers from companies to 3D print masks; efficacy remains unverified but represents necessary innovation.

Epidemiological Outlook (Dr. Bloom)

• Case Fatality Rate (CFR) Accuracy: Current global CFRs are likely gross overestimates due to lack of testing in mild/asymptomatic populations; accurate rates require broad denominator data.
• Modeling & Mitigation:
  • Without intervention, models predict millions of deaths globally; social distancing is required to reduce the reproduction number (R0) below 1.
  • Herd immunity (requiring ~60% population immunity) is not a viable short-term strategy; severe social disruption is necessary for 2–3 months to avoid overwhelming hospitals.
  • Historical precedent (1918 flu) suggests that loosening restrictions prematurely leads to a second wave of greater magnitude.
• Second Wave Risk: A significant second wave is anticipated in Fall 2020/2021 due to the virus's persistence and seasonal factors; containment relies on testing and contact tracing (as seen in Singapore/Hong Kong) rather than "herd immunity" via infection.
• Transmission Dynamics:
  • Aerosol Droplets: Can linger in the air for days.
  • Surface Transmission: Half-life of 45 minutes for large droplets; virus can persist on plastic/steel for ~27–28 hours (though viral load drops significantly over time).
  • Mitigation: Frequent hand washing with soap remains the primary defense against surface transmission.
• Regional Variations: Disparities in reported cases (e.g., Latin America vs. Europe) are attributed to testing disparities rather than weather or biological factors.