Earnings Call, Interview, Conference Presentation, Webinar
In Search for a Cure: Are We Nearing a Treatment for COVID-19?
- The Milken Institute anticipates providing further details on the 23rd Global Conference format in October, with an online format as a potential alternative if in-person gatherings are impossible.
- Without prudent stepwise reopening measures, locations such as Arizona and Texas may face serious concerns regarding increased cases, hospitalizations, and infections within a few weeks.
- If transmission chains are not interrupted, young infected individuals may soon infect vulnerable populations, leading to a predicted rise in hospitalizations and deaths in the coming weeks.
- Areas experiencing the worst spread may need to re-implement shelter-in-place orders or lockdowns, though immediate implementation faces anticipated public resistance.
- Measures like mask-wearing and crowd avoidance are expected to slow but not halt case increases in high-burden areas, particularly once the virus reaches logarithmic growth levels.
- Contact tracing efforts are currently viewed as struggling nationally, though some localities are succeeding, and become increasingly difficult as asymptomatic carrier numbers rise.
- Warm weather is not currently reducing outbreaks, and the virus is expected to persist into the fall, necessitating preparedness for a surge requiring a few months of preparation for identification and isolation.
- A vaccine is expected to be available by the end of this year or the beginning of 2021, though no guarantees exist, with production targets set for hundreds of millions of doses by early 2021 and up to a billion by year-end.
- Phase three vaccine trials are anticipated to begin in the second or third week of July in the United States and internationally, involving 30,000 participants selected from high-burden sites like Florida, Arizona, and Texas.
- Trial enrollment will take weeks to months, with a second dose scheduled for August, while efficacy results are projected for mid-to-late fall or early winter.
- Safety monitoring during trials will focus on antibody-dependent enhancement, with current animal models showing no indication of this occurring, and the FDA will require proof of prevention of infection or disease rather than antibody data alone.
- Pfizer expects to release safety and efficacy data from its 30,000-person trial in September, potentially leading to FDA discussions in October, with initial quantities available starting in October with increasing supplies in November and December.
- Pfizer aims for a production target of 100 million doses in 2020 and 1 billion in 2021, assuming no significant disruptions, and plans to establish separate manufacturing networks for the US and Europe.
- The company's mRNA technology allows for quick adaptation to viral mutations, though logistical cold-chain challenges in developing countries may necessitate second-generation vaccines that do not require -80 degrees storage.
- Industry standards for safety and efficacy will be maintained despite political pressure, with the FDA expected to operate at high speed while adhering to rigorous requirements, potentially responding to submissions within three days.
- Pfizer intends to make a profit on the vaccine but does not anticipate pricing based on the astronomical value of lives and the economy saved.