EU Faces Remdesivir Shortages Amidst Sharp Spikes in New COVID-19 Cases
Supplies of remdesivir are running out across Europe, leading to rationing and reliance on the generic drug, dexamethasone. The UK rationed its supplies of remdesivir Tuesday in the face of rising demands. Poland is in short supply and hospitals in the Netherlands report the drug is out of stock in that country.
The shortages can be tracked to three events:
- The European Commission’s limited purchasing
- A spike in COVID-19 cases
- The purchase of 500,000 courses of treatment (6.25 vials per course) by the U.S.
Last July, in a €63 million deal, the EU bought enough remdesivir to treat 30,000 patients out of a population of 446 million. Health ministers hoped that would supply Europe’s needs through September. The most recent shipment went out October 4th, and the U.K.’s NHS says it expects the rationing to last until late October, when new shipments are due. Now, the European Commission is negotiating with Gilead for additional doses.
Meanwhile, daily incidents of COVID-19 cases in the UK (population of 66.65 million) more than tripled. They soared from 6,968 October 3 – about par for that week – to 22,961 on October 5, according to the EuroNews COVID-19 tracker. Likewise, in the Netherlands (population 17.1 million), daily new cases spiked to 4,000. Russia (population 144.5 million) increased its daily incident count to 10,499 on October 5. For comparison, the U.S. (population 331 million) had a daily incidence rate of 39,557 October 6. The upwards trend is seen throughout much of the world, suggesting a second wave of COVID-19 is beginning.
“We are aware of a rise in the use of remdesivir in line with an increase in COVID-19 hospital cases,” a British health ministry spokesman said in an emailed statement to Reuters. “While there remain plenty of remdesivir supplies, we have asked the National Health Service (NHS) to temporarily prioritize patients to ensure those most likely to benefit can access it.”
In view of the dramatic spike in daily cases, physicians in the UK were advised to save the drug – a broad spectrum antiviral medication – for those who “have the greatest capacity to benefit,” according to the Daily Mail. That means COVID-19 patients who need supplemental oxygen, and only for a maximum of five days.
The Dutch are taking the shortage with equanimity. The paper Dutch News reports the ministry of health has been in talks with the European Commission for weeks to resolve the issue. Mark de Boer, an infectious diseases specialist at Leiden’s LUMC teaching hospital, was quoted in Financieele Dagblad pointing out that remdesivir doesn’t save lives, but shortens hospital stays. Yet, some evidence indicates it does both.
Remdesivir shortens hospital stays by an average of four days, according to research published in the New England Journal of Medicine last May. That study also reported reduced mortality rates of 7.1% for those prescribed remdesivir, compared to 11.9% for patients receiving placebo. Serious adverse events also were reduced.
The drug is one of only two shown to be even moderately effectively against the SARS-CoV-2 virus. The other, dexamethasone, is a corticosteroid long used to treat acute respiratory distress syndrome (ARDS) – one of the symptoms of severe SARS-CoV-2 infections – as well as pneumonia and septic shock. A September 2 paper in JAMA noted significant benefits when dexamethasone was used to treat COVID-19 patients on respirators or supplemental oxygen. There was no benefit, however, for patients who were not receiving respiratory support. For them, early administration of remdesivir remained the best option.
While there are concerns about Gilead’s ability to keep up with demand, Gilead promised last June to have 2 million doses of remdesivir ready this year. The U.S. government contracted with Gilead for more than 500,000 courses of treatment – accounting for most of the doses produced between July and the end of September. Currently, Gilead is working with its own sites and external manufacturers to increase production.
Evoking compulsory licensing to bypass the Gilead patent is not a viable option. The generic medicines association Medicines for Europe dismissed the idea as “inapplicable in Europe,” in an article in PharmaIntelligence. As Adrian van den Hoven, director general of Medicines for Europe, explained, “The (European) Commission drafted the compulsory license regulation to ensure it could never be used in practice.”
Importantly, the shortage appears temporary, and it isn’t global. Gilead has granted licenses to generic manufacturers in Egypt, India and Pakistan. It allows them to distribute remdesivir to 127 low- and middle-income countries, and, importantly, also allows them to sell the drug to upper-income countries facing “significant obstacles to healthcare access,” opening the door to supply generic remdesivir to Europe during the shortage.
The solution for European nations, therefore, is either to wait for Gilead’s production to catch up with demand, or to work with the generic manufacturers licensed by Gilead to launch widespread clinical trials for the generic versions.