Good morning, everyone, and thank you so much for joining for this update on Operation Warp Speed this morning.
Today is an incredibly exciting day for all Americans and for public health: Eli Lilly announced that it received emergency use authorization from the FDA for its monoclonal antibody therapeutic, bamlanivimab, and we've announced that the product's distribution will begin this week.
Based on the data Lilly submitted last month, FDA has authorized this drug for patients 12 years and older with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 or being hospitalized with the disease. Getting therapeutics like this to patients has the potential to save thousands of lives and significantly reduce the disease's burden on our healthcare system.
We have supplies of the product to distribute now because of how Operation Warp Speed provides support for drug companies to begin manufacturing vaccines and therapeutics before they receive regulatory approval. In total, through BARDA, OWS has invested more than $2.77 billion to develop and manufacture therapeutics.
On top of those financial investments, we've helped coordinate clinical trials for OWS-supported therapeutics and helped ensure that manufacturers of these products have access to the materials they need.
We have a contract to purchase 300,000 doses of this product through December, with the option to purchase another 650,000 doses through next June as well. There are over 80,000 doses available for allocation and distribution this week, and we will be working with state, local, and territorial health departments so that patients can receive the infusion in hospitals, outpatient clinics, or alternate care settings.
We'll be allocating the distributions of the drug based on states' and territories' share of the country's total number of confirmed COVID-19 patients and the total number of confirmed hospitalized patients in a given week.
Thanks to Operation Warp Speed's upfront purchases, Americans will not be charged for the drug itself, and we are working with payers and through CMS on reimbursement for administration costs.
Before I hand things over to others to discuss therapeutic progress, allocation, and distribution in more detail, I want to comment briefly on yesterday's exciting data release on Pfizer's vaccine as well.
Back in April, when I was leading discussions across the administration about the project that became Operation Warp Speed, if you'd told me that, by November, we would have exciting data from a Phase 3 vaccine trial and substantial supplies of a monoclonal antibody drug authorized and ready for distribution, I would have been absolutely stunned—and, certainly, I think it's safe to say scientific observers would have been as well.
If Pfizer's product receives FDA authorization, thanks to Operation Warp Speed, we have guaranteed access to 100 million doses, which we purchased for $1.95 billion, with an option for another 500 million more.
Pending FDA authorization, as Pfizer has said, distribution for the U.S. can start in increments of about 20 million doses per month, potentially beginning in late November.
In addition to that pre-purchase agreement that helped de-risk Pfizer's development investments, OWS has supported Pfizer's work in other ways.
We've worked with them to ensure that they have access to the physical ingredients they need to begin manufacturing the vaccines. Operation Warp Speed has also ensured that Pfizer has access to ancillary supplies that will be needed to distribute and administer the vaccine: That includes needles, syringes, alcohol swabs, diluent, and PPE needed for administration, as well as dry ice required for the vaccine's last-mile distribution.
This week is a reminder of the incredible results that Americans can produce when we come together, drawing on the best resources and expertise of the public and private sectors.
I'm grateful to every American who has volunteered for clinical trials, to our incredible team at HHS and the Department of Defense, to the scientists and innovators who've made this progress possible, and to the heroic healthcare workers who will help get these lifesaving tools to the frontlines.
We've talked about building the bridge to safe and effective vaccines. That bridge is taking shape with these new therapeutics and doubling down on promoting good public health measures. Each day, Americans can be even more confident that we're going to get to the other side of that bridge, with the distribution of safe and effective vaccines.
With that, we'll move on to hearing from Dr. Woodcock and Dr. Redd, who have played a key role in advancing and distributing therapeutics throughout this crisis.
