Earnings Call, Conference Presentation
An Update on Therapies and Vaccines
- Social distancing is anticipated to flatten infection curves, while shortages of testing kits and supplies are being partially alleviated.
- Therapies have the potential to be deployed within four to six months to reduce severe illness and hospitalizations, whereas a viable vaccine is expected to take longer to develop.
- Clinical trial data for treatments such as hydroxychloroquine and antibody tests are expected to emerge by the end of the current month, though definitive long-term immunity data remains unavailable.
- While recovered individuals likely experience a period of immunity, it is uncertain whether this protection is lifelong, expected to last a couple of years, or susceptible to viral evolution similar to influenza.
- CEPI's aspirational goal is to deliver a vaccine within 12 to 18 months, with a cautious possibility of readiness for healthcare workers by Fall if conditions permit.
- Ongoing infection waves are expected to continue until 70% to 80% of the population is affected, with current attack rates estimated at less than 10% to 20% in most locations.
- A second wave is considered a certainty unless rigorous monitoring, isolation, and containment measures are maintained.
- Human challenge studies are being evaluated to shorten vaccine development timelines but face ethical hurdles due to the current lack of effective treatments.
- Johnson & Johnson plans to present additional animal data over the summer, begin Phase 1 clinical trials in early September, and expect efficacy studies to start in the October-November timeframe.
- Johnson & Johnson targets a final vector selection by the end of June, pre-master seed manufacturing to commence shortly, and vaccine delivery from its Leiden plant early next year.
- A second manufacturing plant in the U.S. is under construction with an operational goal by the end of the year to support an aim of producing over one billion vaccines next year.
- Regulatory interactions with the FDA and European regulators have reduced Johnson & Johnson's development plan by three months, with emergency use potentially starting in Q1 of next year.
- Direct antivirals typically require five to seven years for development, though utilizing existing compounds could reduce this to two to three years, with Johnson & Johnson considering a five to seven-year timeline.
- Contact tracing is deemed critical for economic reopening, with the CDC exploring technology platforms to support these efforts alongside continued aggressive surveillance.
- CEPI has secured over $800 million of a $2 billion funding goal, while Johnson & Johnson and BARDA have agreed to a combined $1 billion investment over the next 12 to 18 months.
- Realistically, a vaccine is expected to be available later in 2020 or early 2021 for frontline workers or the broader community, with full efficacy studies likely required by mid-next year.
- Society's return to work depends on establishing vaccine efficacy, with a target of demonstrating neutralizing antibodies and protection within 12 to 18 months.