The federal government finally announced initial plans to distribute Gilead's coronavirus drug remdesivir after days of confusion
- The federal government on Saturday announced initial plans for distributing a promising coronavirus drug, remdesivir.
- The drug, manufactured by Gilead Sciences, was authorized for emergency use last week, but doctors and hospitals weren't sure how they were going to get it.
- The Department of Health and Human Services now say the drug is first being distributed to health departments in some hard-hit states, and the departments can distribute it to hospitals as they see fit.
- Eventually, HHS expects the drug to be delivered to all 50 states, terrorities, the Veterans Health Administration and the Indian Health Service.
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The federal government released its initial distribution plans today for the promising coronavirus drug, remdesivir, which was approved for emergency use last week.
The drug, donated by manufacturer Gilead Sciences, "will be used to treat hospitalized COVID-19 patients in areas of the country hardest hit by the pandemic," the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) said in a press release.On May 7, ASPR started the process of delivering cases of the drug, which contain 40 vials each, to Connecticut, Illinois, Iowa, Maryland, Michigan, and New Jersey. Cases have already been sent to Indiana, Massachusetts, New Jersey, New York, Rhode Island, Tennessee, and Virginia.Advertisement
How many cases of the drug each state gets varies, with New York receiving 565 cases, for example, and Iowa receiving 10. The government's press release contains a full list of how much of the drug each state is getting.
It's up to state health departments to distribute the doses to hospitals "because state and local health departments have the greatest insight into community-level needs in the COVID-19 response, including appropriate distribution of a treatment in limited supply," according to the press release.Eventually, ASPR said it expects to deliver remdesivir to all 50 states, territories, the Veterans Health Administration and the Indian Health Services. The government didn't provide a timeline for the shipments, or say how it decided how much of the drug each state will get.
Days after remdesivir was approved for emergency use, frontline doctors still had little information about how and when the drug would actually get into their hands in order to treat patients who urgently needed it, Business Insider first reported on Wednesday."There is currently significant confusion and lack of information regarding the criteria the federal government is using to allocate this limited supply of donated remdesivir," Dr. Julie Ann Justo, an infectious-disease physician at Prisma Health-Midlands, a health system headquartered in Columbia, South Carolina, previously told Business Insider.Read more: The FDA raced to let doctors use the promising coronavirus treatment remdesivir. Now, hospitals are stuck waiting for supplies to show up.Advertisement
All told, Gilead Sciences said it will supply approximately 607,000 vials of the drug to the US over the next six weeks, enough to treat an estimated 78,000 hospitalized COVID-19 patients under emergency use. The donation to the US is part of 1.5 million vials of remdesivir the company is donating worldwide, the press release stated.
Remdesivir seems to shorten how long it takes to recover from COVID-19There are still no FDA-approved treatments for coronavirus, but the World Health Organization has called remdesivir "the most promising" COVID-19 treatment. Advertisement
The antiviral was found to be safe — though not entirely effective — for people with Ebola, and research in test tubes and monkeys has suggested it might help fight COVID-19. The first known person with COVID-19 in the US also began to improve the day after receiving remdesivir.
Most recently, a critical trial out of the National Institutes of Health of more than 1,000 hospitalized patients found that those taking the antiviral recovered in 11 days, on average, compared to 15 days among those who took a placebo. It's not clear if the drug lowers the chances of dying from COVID-19, though.The preliminary research prompted US regulators to approve the drug for emergency use, meaning healthcare professionals could use it to treat severe cases of suspected or known COVID-19 long before it becomes an FDA-approved treatment. Advertisement
"Severe disease," in this case, means COVID-19 patients have low blood oxygen levels, need oxygen therapy, or need breathing support like a ventilator.
The only other way to access the drug is to enroll in a clinical trial.
Questions remain about remdesivir distributionSaturday's announcement still leaves big questions about the government's plan to distribute remdesivir.Advertisement
—Rachel Sachs (@RESachs) May 9, 2020
Rachel Sachs, an associate professor of law at Washington University, criticized HHS on Twitter for "abdicating its own responsibility" for doling out the drug and placing the burden on state health departments.She also said today's announcement contradicts previous reports that remdesivir shipments went directly to hospitals, didn't clarify who made past decisions, and didn't indicate why certain states are receiving cases first or in larger quantities. Ultimately, she pressed someone to own up to these decisions. "The refusal to take responsibility for the rollout is disappointing," she wrote.Advertisement
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