Earnings Call, Conference Presentation
An Update on Therapies and Vaccines
- Call Context & Date: Hosted by Sharmin Mosavar-Rahmani (Goldman Sachs CIO Wealth Management) on April 14, 2020, as the eighth in a series regarding COVID-19.
- Current Epidemiological Status: As of the call, total reported infections approached 2 million with fatalities exceeding 110,000; social distancing was noted as potentially flattening the infection curve.
- Timeline Reference: China's lockdown in Wuhan occurred on January 22, 2020, and the first U.S. case was reported on January 15, 2020.
- Therapy Deployment Horizon: Experts estimate potential for effective therapies to be deployed within 4 to 6 months, whereas viable vaccines may require 12 to 18 months.
- Therapy Pipeline Volume: Faster Cures is currently tracking 120 potential treatment compounds across various categories.
- Antibody Therapies: 38 tracked candidates focus on plasma from recovered patients or synthetic versions; examples include Regeneron's engineered mouse antibodies and DARPA-sponsored efforts.
- Antiviral Focus: 18 candidates fall under antivirals, including Remdesivir, which targets viral replication and is analogous to HIV treatments.
- Hydroxychloroquine Status: Results remain mixed due to reliance on small, preliminary studies; the Gates Foundation and NIH are funding larger trials to assess prophylactic and treatment efficacy.
- Remdesivir Data: A preliminary study published in the New England Journal of Medicine showed 68% improvement and a 13% mortality rate among 53 hospitalized patients; however, the study lacked a randomized control arm.
- Cytokine Storm Treatments: Preliminary data suggests Actemra (tocilizumab) may assist hospitalized patients exhibiting cytokine storms, though specific efficacy for COVID-19 requires further study.
- Platform Studies: WHO and NIH are utilizing adaptive, randomized, double-blind platform trials (e.g., Solidarity trial) to rapidly add or remove compounds from a single study design.
- Serology Testing Accuracy: Early antibody tests measure IgM (detectable 7–10 days post-infection) and IgG; the NIH launched a study with 10,000 volunteers to assess test efficacy and viral spread.
- Immunity Uncertainty: Current data does not confirm long-term immunity from prior infection or protection against a second wave, as coronaviruses are known to cause recurring colds and mutate.
- CEPI Mission: The Coalition for Epidemic Preparedness Innovations (CEPI), established post-Ebola (2017), aims to accelerate vaccine development for epidemic threats and ensure global access.
- CEPI Rapid Response: CEPI announced three vaccine programs on January 23, 2020, leveraging existing rapid-response technologies for DNA and RNA platforms developed against MERS and other coronaviruses.
- CEPI Funding Milestone: CEPI secured over $800 million toward its $2 billion goal, including a $250,000 contribution from Goldman Sachs.
- Vaccine Portfolio Diversity: CEPI funded 8 candidates using diverse platforms: Inovio (DNA), Q-Pharm (protein), Moderna (RNA), CureVac (RNA), and others selected to manage development risk.
- Viral Mutation Risk: SARS-CoV-2 is an RNA virus that mutates rapidly; while clades are emerging, their impact on vaccine efficacy remains unknown, potentially requiring annual vaccine updates similar to influenza.
- Vaccine Timeline Estimates: Dr. Hatchett and Dr. Stofos project an aspirational timeline of 12 to 18 months for vaccine availability, with potential emergency use for frontline workers by Q1 2021.
- Second Wave Risk: Dr. Hatchett predicts a second wave is "certain" if 70–80% of the population has not been infected, noting current attack rates are likely below 10–20%.
- J&J Manufacturing Capacity: J&J's VSV vector platform can yield 300 million vaccine doses annually per 2,000-liter vessel using the PER.C6 cell line; capacity is being scaled to over 1 billion doses by next year.
- J&J Clinical Pathway: J&J selected a lead vaccine candidate in March with two backups; Phase 1 trials are targeted for September 2020, with potential emergency use authorization in Q1 2021.
- J&J Government Partnership: J&J and BARDA announced a joint $1 billion investment to accelerate vaccine development, with the U.S. government covering half the cost and facilitating FDA regulatory interaction.
- Regulatory Acceleration: Continuous interaction with the FDA and European regulators has reportedly shaved three months off J&J's development timeline.
- Antiviral Research Strategy: J&J is screening its own libraries and accepting compounds from other pharmaceutical companies, though identifying effective direct antivirals is historically a lengthy process.
- Reopening Policy Requirements: Ms. Krofa emphasizes that safe economic reopening requires aggressive surveillance, widespread testing, and contact tracing technologies to identify and contain hotspots.
- Forward-Looking Disclaimer: All speakers noted that the information presented is in a highly uncertain environment and does not constitute financial advice.