Having a COVID-19 therapy approved through an emergency use authorization (EUA) is not the same as having access to it, even if it’s free.
Accounting for one-third of the nearly 4 million COVID-19 cases confirmed globally as of Monday and 28.5% of the 278,957 deaths, the U.S. is getting 40% of the 1.5 million vials of remdesivir Gilead Sciences Inc. is donating worldwide. When Gilead, of Foster City, Calif., first announced the donation, some people expected the U.S. would get as much as 80% of the supply, according to Brian Abrahams, a senior analyst with RBC Capital Markets LLC.
Given the U.S. share of the current supply and the manufacturing timeline for the first drug granted an EUA to treat severe COVID-19 cases, more than 300,000 eligible U.S. patients likely will not have access to remdesivir through the end of July, Abrahams said. He added that he expects the supply constraints to continue through nearly the end of the year.
More immediately, there won’t be enough of the drug to cover even half of the eligible U.S. patients in May, Abrahams said. Part of that is due to a slower-than-anticipated government distribution of the donated doses.
After distributing nearly 34,000 doses early last week to New York, the U.S. coronavirus hot spot, as well as a couple of neighboring states and a few states not as heavily hit as others, the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) announced its allocation plan for remdesivir Saturday.
Under the plan, ASPR will allocate the vials to the states. Then “state health departments will distribute the doses to appropriate hospitals in their states 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 ASPR.
The agency plans to deliver remdesivir to all 50 states, U.S. territories, the Veterans Health Administration and the Indian Health Service with the stipulation that the donated drug be used only for patients on ventilators or on extracorporeal membrane oxygenation or who require supplemental oxygen due to room-air blood oxygen levels at or below 94%.
While ASPR said it has contacted state health officials regarding the allocations, it didn’t explain how it selected states for the initial allocations or determined how many cases of vials to send to each state. For instance, the first allocation made last week understandably included New York, New Jersey and Massachusetts, the three states with the highest number of confirmed COVID-19 cases. However, Indiana, Virginia, Tennessee and Rhode Island also received doses in that first distribution. Those states rank 14, 15, 19 and 22, respectively, in terms of their number of coronavirus infections.
ASPR distributed more of the drug Friday – to Connecticut, Illinois, Iowa, Maryland and Michigan, with a second distribution to New Jersey. Illinois has the fourth highest number of COVID-19 cases and Michigan ranks seventh in the number of cases but fourth in the number of deaths. However, Iowa ranks at 21. Meanwhile, California, Pennsylvania, Florida and Texas, which are all among the 10 states hardest hit by the pandemic, were not included in the first distributions.
Sens. Edward Markey (D-Mass.) and Elizabeth Warren (D-Mass.) and Rep. Ayanna Pressley (D-Mass.) wrote to HHS Secretary Alex Azar and Vice President Mike Pence Friday calling on the government to explain its distribution methodology, as it could shape patient access to future COVID-19 treatments.
“The federal government must ensure that the distribution of COVID-19 therapies such as remdesivir, or future vaccines, is transparent and orderly, and that these treatments reach highly impacted areas that are in need of these critical resources the most,” the lawmakers said.
Besides donating its current inventory of remdesivir, Gilead is building a consortium of manufacturing partners to help maximize the global supply of the antiviral. “Producing the drug requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities with limited global capacity,” Gilead said last week. “Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so.”