Government gears for unprecedented challenge of Eli Lilly antibody rollout as efficacy questions linger
After months of anticipation, the FDA has authorized the first antibody treatment for Covid-19. Now what?
The US government faces a challenge unlike virtually any it has faced during or before the pandemic. They will have to distribute scarce quantities of a much-sought drug throughout the country at a time when cases are reaching record levels, overburdening hospitals to the point where, in North Dakota, Covid-19 positive nurses have been authorized to continue working.
The government did not initially fare well last time it had to roll out a Covid-19 drug; in the spring, baffled doctors reported that hospitals with few Covid-19 patients received precious vials of remdesivir, while those with many were overlooked. Distributing an antibody poses an even greater challenge, as it’s indicated for patients with mild or moderate disease — a much larger group of people, none of whom are already in a hospital, where an IV infusion can be easily administered.
On Tuesday, CDER chief Janet Woodcock, who stepped away from the FDA to run the treatment arm of Operation Warp Speed, outlined the government’s plan to distribute the 300,000 doses they’ve agreed to purchase from Eli Lilly. They will rely largely on a system that officials eventually developed for distributing remdesivir: Rather than give the drug directly to medical centers, they will allocate it to states and territories according to how many Covid-19 cases and hospitalizations they have. Local governments would then allocate it within their jurisdictions.
For example, in the first allocation this week, the large and hard-hit state of Texas will receive 5,780 doses. Vermont, which is small and has kept the virus under relative control, will receive 20.
Still, outside experts said that left key questions unanswered. Much of the country still does not have enough testing capacity to catch cases within the narrow window where early studies indicate the antibody may be beneficial. And although authorities want to reserve the drug for patients who are at high risk, such as those with diabetes or obesity, that still leaves far more demand than supply.
“In some populations, you have half the people who will meet that high-risk criteria, so who you give it to and how you make that decision isn’t clear,” said Helen Boucher, chief of infectious diseases at Tufts Medical Center in Boston, told The Washington Post. “The worry is whether black and brown people get access who we know are being disproportionately affected by this disease.”
The distribution will happen while questions linger about how effective the drug really is. Although only the medium, 2800 mg dose of the antibody met the primary endpoint of reducing viral load in Lilly’s pivotal trial, the FDA authorized a 700 mg dose and HHS is sending vials containing that dose to the states.
The 700 mg dose will allow them to give the drug to far more people, and Lilly says that all doses showed “similar clinical effects,” such as decreasing the risk of hospitalization and reducing symptoms. Woodcock defended the government’s decision on a call with reporters, pointing to the data Eli Lilly collected on hospitalization and symptom alleviation.
She argued that most people clear the virus on their own and that, among those who didn’t, all three doses of the drug reduced viral load. The p-value for the 700 mg dose was 0.38.
“I think you are sort of accepting a dichotomous view of p-values,” she said, according to BioCentury. “If you look at the virology data, there was almost no difference in virus clearance amongst the different doses.”
For Woodcock, the bigger question is the rollout. The government is planning to distribute the antibody in two phases, and eventually hopes to distribute it, via states, to parking lot tents or trailers, which may be more accessible. First, though, they’ll have to see if old-fashioned hospitals, urgent care centers and ERs can do the trick.
“For the next two weeks, what we’re going to be looking at very closely is the ability of the healthcare system to actually get this into people’s veins,” Woodcock said.