Uncontrolled Spread: Science, Policy, Institutions, Infrastructure

Sep 20, 2021

Guest

Vineeta Agarwala

Scott Gottlieb, former head of the FDA and author of 'Uncontrolled Spread,' dives into the lessons learned from the COVID-19 pandemic. He discusses the critical role technology, particularly mRNA vaccine development, played in pandemic response and highlights failures in regulatory translation of science to policy. Joining him are Marc Andreessen, a prominent venture capitalist, and Vineeta Agarwala, a bio expert. They explore the need for improved genomic surveillance, private sector involvement in health infrastructure, and the ethical dilemmas of challenge trials for future preparedness.

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INSIGHT

mRNA Vaccine Adaptability

The manufacturing process for mRNA vaccines offers plug-and-play capabilities, making it theoretically easier to adapt than influenza vaccines.
This is because mRNA vaccines don't require egg adaptation, which can introduce changes in the protein and affect clinical outcomes.

INSIGHT

Variant-Specific Vaccines

There's a tradeoff between optimizing mRNA vaccines for new variants and maintaining efficacy against existing strains.
Using the current vaccine offers known efficacy against a range of strains, while switching to a variant-specific vaccine introduces uncertainty.

ADVICE

Future Vaccine Approval Process

Future licensure of variant-specific mRNA vaccines won't require large outcome studies like the initial COVID vaccines.
Instead, smaller non-inferiority trials supplemented with immunogenicity data and in vitro neutralization data will likely suffice.

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There's no question technology played a huge role in the recent/current pandemic, including especially in the plug-and-play engineering and incredibly fast development behind the mRNA vaccines... But is there an even bigger role for the private sector, not just government, to play (and partner) when it comes to key infrastructure for future such emergencies, and even beyond?

Especially given how faulty the translation of institutional science to policy and public health measures turned out to be -- for instance, with "6 feet" of social distancing, or with fomite (vs. aerosol) transmission of COVID. And why are we still talking about the same, not specific, vaccine booster for the Delta variant? What can we learn about real-world evidence, other clinical trial approaches, and progressive (vs. binary) EUA approvals when it comes to public health emergencies? Are capabilities like genomic surveillance and mapping strains -- which require layers of technology, real time -- sitting in the right places?

In this special book-launch episode of the a16z Podcast, former FDA commissioner Dr. Scott Gottlieb -- author of the upcoming new book, Uncontrolled Spread: Why COVID-19 Crushed Us, and How We Can Defeat the Next Pandemic -- shares insights on the above, and revealing stories from behind the scenes. Do we need a new entity to manage public health through a national security lens, and is the government capable? Gottlieb debates this and other probing questions from a16z co-founder Marc Andreessen (who famously wrote "It's time to build"); a16z bio general partner Vineeta Agarwala MD, Phd (who has spoken about the trials of clinical trials, practiced medicine during the pandemic, and more); and founding a16z bio general partner Vijay Pande PhD (who, among other things, founded the distributed computing project Folding@Home which pivoted to COVID proteins).

One thing's for sure -- with this COVID crisis, we're at an inflection point between old and new technology -- whether it's in how we make vaccines, or how we apply the fields of synthetic biology and genetic epidemiology in public health response. So now's the time to look both backward, and forward, to really change things...