Can We Make Enough Covid Drugs?

here's what happened in virus News today. A promising new COVID nineteen vaccine is getting closer to being ready for widespread distribution. Visor said a final annalo this showed its vaccine was effective. That paved the way for the company to apply for the first US regulatory authorization for a coronavirus shot within days. Fiser and partner bio en Tech said their vaccine protected people of all ages and ethnicities with no significant safety problems so far in a trial

that includes almost forty four thousand participants. In Germany, a protest over distancing and hygiene rules turned violent. Berlin police used water cannons to break up a large demonstration near the Brandenburg Gate, where thousands of people had gathered. Pressure has been growing on German authorities, who are facing a crunch meeting next week to lay out a long term

plan to fight the pandemic. With restrictions likely to be extended and intensified, public anger and political tensions are rising. The entire New York City Public school system will close on Thursday, according to an email from Chancellor Richard Carranza to School Principles. The shutdown was prompted by New York City reaching a three percent test positivity rate over a

seven day rolling average. Moving to distance learning will affect the approximately three hundred thousand children who have been attending in person classes since schools reopened in early October. Finally, the US gave the green light for the first COVID nineteen self testing kit, adding a tool to battle the

pandemic as nationwide testing capabilities come under more strain. The Food and Drug Administration issued an emergency use authorization to la Sierra Health's Rapid Result all in one test kit. While some COVID nineteen tests allow people to provide samples from home, this is the first that can be fully self administered and provide results at home in thirty minutes or less, and now for today's main story. In a

mere nine months, Eli Lily accomplished an unprecedented feat. The drug giant took a blood sample from one of the first US patients to recover from COVID nineteen, identified an antibody that could fight the virus, and created a version of that antibody to treat people with the disease. Reporter Riley Griffin spoke to Lily's chief executive officer, David Ricks about the challenges facing the company and its new treatment

among the worsening pandemic. So, Riley, you spoke to Lily's chief executive officer, David ris just after they were given the green light from regulators about their new antibody treatment. I was wondering if you might give us a brief introduction to exactly how Lily's treatment works. Absolutely so, what this class of treatments, known as monoclonal antibodies is is there man made versions of antibodies that the body produces

in response to the infection of the novel coronavirus. So Lily and its partner Abseller actually identified one of the earliest patients in the US who have recovered from the coronavirus and back in the early months of the pandemic um they used that information, that sample to create their

own product. And it's an intravenous injection that you receive in a hospital setting and an outpatient setting, and it ultimately it's best use as we know right now, is to treat those with COVID nineteen that are at early stages of symptoms, so not those who have progressed to the hospitalized setting. Obviously, this is great news. And what was David Rick's reaction to news of the approval when

you spoke to him, David Ricks was incredibly excited. Yeah, well, obviously we're excited, and I'm most excited for the scientists who I know who work at our company. And we're not done, of course, we can, as you know where working on improve versions and getting a full license for this. Would like to get it approved in Europe and other countries, but perhaps it's the end of the beginning for very effective treatments for newly diagnosed patients with stars code two.

This is a scientific feat that those that Lily, those seller, those that the n i H are so excited about. It is a tool seen as a bridge to a vaccine to treat those at the early stages of their disease and prevent them from progressing to the hospitalized setting. So it's another thing to add to the toolkit of doctors who are looking to treat those with COVID nineteen, particularly in a moment where we are seeing global surges in cases. This green light is certainly good news. Challenges

are not over yet. I mean, what would you say is the biggest hurdle that Lily is anticipating in say, the weeks or months to come. Lily is quite concerned about supply. I think the most notable thing out of this conversation with David Ricks was really that capacity. No matter how much manufacturing capacity they have, no matter how many deals they reach for additional firepower to boost supply, there simply is not going to be enough. The real

challenge is about scale. I don't think we would have for difted back in April when we triggered the decision to start manufacturing at pretty big scale million doses this fall that we may need all of those. And then so it occurred to us, you know a few months later that might be true. And now we're in the middle of the surge and I think we did everything

we could, but still it may not be enough. So we have to continue try to squeeze out as much supply as we can, and unfortunately that's not a quick turnaround time, but clearly we'll be needed. Um, it's really quite concerning to David Ricks. I'll have you know that within the first week they've shipped out eighty eight thousand doses of this antibody, but just consider the sheer number

of cases on a daily basis. So with any new treatment for COVID nineteen, concerns are tied up with distribution. Who will be able or eligible to receive the new antibody therapy from Lily. The Food and Drug Administration has authorized the experimental treatment for use against mild to moderate COVID nineteen in adults, including those who are sixty five

and older, as well as pediatric patients. Lily will supply the product, but the US and a distributing partner will determine how to allocate this product based on need, So where there are cases, it will proportionately be distributed to states, territories, municipalities, cities, and so forth. It will take a little bit of time for doctors to learn about this and start getting

getting their own experience. But that's against the background of probably something like a million patients diagnosed with COVID nineteen this week in the United States. Amongst those million, we

would estimate something like or high risk. So design enough supply to go around the US is going to have a challenging time at that sub level, at the local level, determining who is high risk within this camp, because the number of mild to moderate nineteen patients in this country is massive at this point in time as we see

a US surge unfold. So Riley, you've already identified some serious challenges just on the US level, and Lily has agreed to supply the US with the initial three hundred thousand vials of the therapy, but there will be obvious global demand for this therapy. How is Lily going to meet that demand? This is a fascinating question because Lily is approaching the question of supply and demand very differently

than we're seeing others who are developing both treatments and vaccines. Um, Lily did clinch this deal for three hundred thousand vials of the antibody treatment, but the U S has this option to purchase an additional six hundred and fifty thousand vials. Now you got to read the fine print in that, because those six fifty thou vials will only go to the US if Lily and the federal government determined that the need is high here and higher than elsewhere. We

know we have more capacity. At the time we signed that deal, interested in making sure that there was access to this medicine no matter where the disease was. You know, it's raging in Europe as well. Of course, Europe hasn't approved the drug and they haven't contracted with US yet. So while that's the case, I think our ability to get more drug to the US will go up because they've got this option. But the option is a two

way option, so that both parties need to agree. So it's an agreement to agree later, and it is currently designed to kick in two months after the initial emergency use of authorization. I'll tell you if if no other country approves this or contracts, then we'll be at liberty to just get more products to US patients who need it. If Europe approves this quickly and wants to contract again at the same race as the US we'll we'll shift product to them as well. There's of epidemic and particularly

in France right now that it's very concerning. So um, you know, we want to get the product to where it's needed. Most many of the companies that have agreed to deals with Operation Warp Speed have agreed flat out here is a price that they receive for a dose. Right. But Lily with these vials, is saying you can have these vials if and only if there is significant need. Now, what Ricks did say is it's looking like there is going to be significant need here in the US as

the pandemic surges on. But we'll we'll wait to see in the months to come whether it taps into that supply. So Riley, finally, how does Lily anticipate working with the Biden administration? Have the results of the election changed any of their plans? Rix made a fascinating point here, which is Operation Warp Speed is working eli Lillian Company and the broader drug industry is incredibly supportive and in fact applauds the work of the White House lead Operation Warp

Speed effort. An important thing to note, however, is that Lily has not taken capital from Operation warp Speed for its R and D or its manufacturing. The deal it's clinched is for supply and supply alone. You might know the name Visor at this point and its partner by on Tech. They're in a similar camp. Those two companies did not take money for research and development or manufacturing capacity,

but really just those doses. And that's quite novel. Again, it's different from those like Johnson and Johnson or Maderna or even Regeneration here in the antibody space that I've taken money for initial research. It was very important for Lily to have put down that risky investment from the get go, and we will see what liberties that will allow them moving forward both amid the pandemic in a post pandemic world. That was Riley Griffin. And that's it

for our show today. For coverage of the outbreak from one and twenty bureaus around the world, visit Bloomberg dot com slash Coronavirus and if you like the show, please leave us a review and a rating on Apple. Podcasts are Spotify. It's the best way to help more listeners find our global reporting. The Prognosis Daily edition is produced by Topha foreheads Jordan Gospure, Magnus Henrickson, and me Laura Carlson. Today's main story was reported by Riley Griffin. Original music

by Leo Sidrin. Our editors are Rick Shine and Francesco Levi. Francesco Levi is Bloomberg's head of podcasts. Thanks for listening to