The Trump administration said Tuesday it is starting to send out 300,000 doses of a COVID-19 antibody treatment from Eli Lilly and Co., one day after federal regulators approved it for emergency use.
The Department of Health and Human Services said state and territory health departments will determine which health facilities receive the drug, called bamlanivimab, so they can help patients with mild-to-moderate illness stave off a serious bout or a hospital stay.
“The goal is to stop progression of the disease,” said Janet Woodcock, the therapeutics lead for Operation Warp Speed, a White House initiative to develop drugs and vaccines for COVID-19. “The goal here is to intervene very early.”
Federal officials can purchase buy up to 650,000 additional doses, as needed, through June 30 under the government’s agreement with the drugmaker. Doses will be provided at no cost to patients, though health facilities may bill for the cost of administering the drug.
The monoclonal-antibody treatment, which mimics the body’s immune system to fight the coronavirus, was given to former New Jersey Gov. Chris Christie as he was sick with the virus last month. It is similar to the investigational treatment from Regeneron Pharmaceuticals that President Trump received during his COVID-19 illness.
The Food and Drug Administration’s approval of the Eli Lilly version late Monday raises hopes that groundbreaking treatments and progress on a vaccine will put the pandemic on a better trajectory, as cases spike and an average of more than 900 people die each day in the U.S.
Pfizer on Monday said its COVID-19 vaccine was 90% effective in a preliminary analysis of its late-stage trial. But any immunization campaign will last well into 2021, meaning therapeutics and other interventions remain critical.
Health and Human Services Secretary Alex M. Azar II, a former Eli Lilly executive, called the release of the antibody drug an “incredibly exciting day for all Americans and for public health.”
Mr. Azar noted that doses are going out the door so quickly because Operation Warp Speed ensured that drugs and vaccines are prepped before approval.
HHS said weekly allocations of the drug will be proportional to confirmed COVID-19 cases in the states. The administration also will look at hospitalizations to determine which states have large shares of people who worsen to the point of needing inpatient care, even though the drug is not intended for people who are already in the hospital.
There are a series of limitations that federal and state officials and health care providers will have to confront during the rollout.
One limitation is supply. The drug is intended for people at high risk — for instance, people with bigger bodies or people over 65 — so doctors will have to consult an FDA checklist of risk factors as they draw down their allotments.
Howard Koh, a professor of the practice of public health leadership at Harvard T.H. Chan School of Public Health, said with more than 100,000 new infections diagnosed per day, there likely will be rigorous debate about how patients are prioritized.
“If we’re not careful, those doses could be used in a matter of days,” he said.
Federal officials on Tuesday fielded multiple questions about why the FDA authorized a 700-milligram dosage instead of the 2,800-milligram amount cited as most effective in published studies. The administration argued the recommended dosage will be sufficient.
“You don’t want to give more of a drug than you need,” Dr. Woodcock said. “Giving the lowest dose that gets the job done is a very important thing.”
The drug is given intravenously, so there are logistical challenges. HHS said outpatient settings must have adequate health care staffing, training and equipment, so some facilities might need prep time before they can accept patients and use the drug.
The infusion takes about an hour and must be followed by an observation period. Also, health providers must be ready to treat a severe reaction, such as anaphylaxis.
In blunt terms, the immediate challenge is how to “get this into people’s veins,” Dr. Woodcock said.
“We’re going to see how well the health care system is able to absorb this,” she said.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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