a16z Podcast Uncontrolled Spread: Science, Policy, Institutions, Infrastructure
Sep 20, 2021
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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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.
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.
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.
