Operation Warp Speed’s Notaristefani on Getting Every Last American Vaccinated

This episode of The Vaccine Challenge is hosted by Priyanka Asera and features Carlo de Notaristefani, Lead Advisor Manufacturing & Supply Chain at Operation Warp Speed. Operation Warp Speed is a public–private partnership initiated by the US government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines. We’ve asked Carlo some really important questions around how OWS works with the FDA and CDC, what are the actual number of vaccines in the pipeline waiting to be authorized, how many Americans have already been inoculated, why the embargo on vaccine raw materials to rest of the world, the basic supply chain of vaccine development, and whether there will be permanent changes in the world of drug discovery, development and approval timelines given the speed at which these vaccines have come to market. If you want to hear more from Carlo, he is a speaker this year at the Disease Prevention & Control Summit, a two-day virtual event taking place on July 20-21st, focusing on some of the most important topics across the COVID-19 space, including vaccines, therapeutics, diagnostics, and health equity. Priyanka will also be moderating a panel on vaccine distribution, so make sure not to miss it! Link to register for free is below. Link to free registration: https://bit.ly/2Qzvjpy Summary of the podcast interview: What is Operation Warp Speed and What Are Its Objectives? OWS is a public-private partnership set up to accelerate the delivery of vaccine and therapeutics in order to supply to the whole US population Model was set up initially like The Manhattan Project. A special task-force set up within the US Government bringing different kinds of experiences and expertise to deliver a well-defined outcomeIntegrated effort between Health and Human Service Department (HHS), and the Department of Defence (DoD) that brought their logistics expertise, and some experienced pharma experts like Carlo. FDA which is the regulator is tasked with regulating and approving the vaccine and was not included as part of OWS in order to retain its full independence to judge the outcome in an objective manner What goals were set up originally and what has been actually achieved? Initial goal that was set was to deliver 100mn dozes of vaccines by end of 2020, and 300mn dozes by end of Q1 2021. OWS didn’t fully accomplish that goal, but came close. Did 30mn dozes by end of 2020, and 230mn dozes by end of Q1. Distributed over 280mn dozes as of today.As of today, 70mn people have had both dozes, and over 130mn people have had at least one doze. How did OWS decide which vaccines to support prior to approvals? In May 2020, the first significant decision to be made was which vaccines should be selected to support, accelerate and develop, out of the 60 candidates under development in the world at the time. Driver of this decision was based on “likelihood of success” and “minimization of risk”3 key platforms were selected– Messenger RNA, viral vector and spiked protein. For each of these 3 platforms, 2-3 candidates were chosen based on what appeared most promising based on the preliminary data available and the stage of development.Finally, 7 candidates were selected. Pfizer/BioNTech, Moderna, Astra Zeneca Oxford, Janssen, Novovax, Sanofi, & Merck. How did these vaccines get approved so quickly in record time? Since this has never happened before, can its quality be relied upon? “Speed” is a doubled edged sword. People get concerned that by trying to accelerate you may cut corners and impact the quality of the outcome.We’ve absolutely not cut corners with regards to the safety, efficacy, compliance and quality. Instead, financial risks were taken to reduce lead times. We decided to look at what can we do in parallel? So we started manufacturing the vaccines well before knowing whether the vaccines will be safe and effective. That means, if the clinical trial delivered a negative result we’d have wasted a significant amount of money from manufacturing millions of dozes without knowing whether the dozes will be effective or not.We built the refrigeration capacity over time. We decided to take the financial risk to build the infrastructure and capacity without knowing whether the vaccine was going to be effectiveThe resources that the US government has allowed us to take that financial risk. A private company could never have done it. That’s how we managed to reduce timelines.Similarly we partnered with NIH and hospital chains to support clinical studies of the US government. We set up a mobile network of clinical study centers to follow where the pandemic was in the country. This was a very capital intensive way of doing it but allowed us to recruit patients exactly where the hotspots of the country were. Which vaccines have been approved, and which are waiting to be approved? In the US, 3 vaccines have been approved (as of April 16th).First was ...