Public Health Watch: A Call for Clarity on Remdesivir Distribution

Assuming researchers ever find a viable treatment—if not out in a cure or vaccine—for coronavirus 2019 (COVID-19), it remains imperative that potential candidates, pharmaceuticals or “alternative” remedies, get into the hands of researchers, for clinical evaluations, and clinicians to manage at-risk patients.

That’s essentially the argument made by a commentary pertaining to distribution of remdesivir, published by JAMA Network Open in mid-May. Despite the fact the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Gilead’s antiviral therapy on May 1, “details about how this drug will become available are opaque and distribution remains limited,” the authors wrote.

“I think the issues is critically important,” commentary coauthor Michael G. Ison, MD, MS, professor in the Divisions of Infectious Diseases and Organ Transplantation at Northwestern University Feinberg School of Medicine, told Contagion®. “Something similar may happen with other drugs, and will definitely be an issue for vaccines—there will be insufficient vaccine initially after approval.”

He added, “The same issues may persist if we have the same leadership directing allocation," referring to the various leaders of the relevant federal agencies, including the FDA and the US Centers for Disease Control and Prevention (CDC).

In other instances in which an EUA has been issued for a drug, a recent example was the being intravenous peramivir during the 2009-2010 H1N1 influenza pandemic, the CDC was responsible for managing the drug distribution, Ison and his colleagues noted. Only 1200 treatment courses were initially available for distribution, they added, and data collected for outcomes and adverse events associated with treatment were limited.

In the case of remdesivir for COVID-19, the disease caused by the new coronavirus, SARS-CoV-2, drugmaker Gilead announced it planned to donate 1.5 million doses of remdesivir to the US government. However, the US Department of Health and Human Services stipulated that “only 607,000 vials” of the drug would be made available “over the next 6 weeks” (as of May 1), according to Ison et al—or sufficient supplies to treat an estimated 78,000 hospitalized patients with the virus.

It goes without saying the far more Americans have been hospitalized with COVID-19 in that time—with only more to come, unfortunately.

Since the commentary was published, “there has been more detail about the allocation process,” Ison told Contagion®. However, “questions still remain (as to) when additional allocations can be made. Further, since there was no guidance made for states, it’s unclear how (federal health officials) made decisions.”

Although, as Ison said, trials to date suggest remdesivir offers only “limited benefit in patients with very mild illness and with patients with very severe illness…(l)ikely in reducing viral loads in patients before they get too sick,” a treatment with even limited efficacy and proven safety is likely better than no treatment at all for some patients. And clinicians need clarity as to how—and when—they will have access to it.