World Health Organization panel advises against administering remdesivir to critical Covid-19 patients
Nov 21 2020
It was given emergency use authorisation from the Food and Drug Administration in the United States on May 1 and taken by US President Donald Trump when he was admitted to hospital with COVID-19 in early October.
Remdesivir is now approved for use as a COVID-19 in over 50 countries and was one of the medications administered to US President Donald Trump when he was diagnosed in October.
"There is now no evidence that it improves survival or the need for ventilation", a panel of WHO-convened experts developing Covid-19 treatment guidelines said in The BMJmedical journal.
Final results from Pfizer's pivotal Covid-19 vaccine trial show it had a 95% success rate - even higher than an earlier analysis - and two months of follow-up data without serious side effects, the company said on Wednesday.
The approval was based on a review of the data from a clinical trial of hospitalized COVID-19 patients sponsored by the National Institute of Allergy and Infectious Diseases.
The WHO guidelines stress that the drug does not save lives, based heavily on a WHO-sponsored study that was larger but much less rigorous than the USA -led one that found it had other benefits.
Those broader considerations that the World Health Organization is considering include the cost of remdesivir, the complexity of administering it in a medical setting, the potential risks giving it as an infusion - and weighing that against the potential benefits.
The WHO Guideline Development Group (GDG) described the drug as an expensive "gamble" - a five-day course of treatment for one patient costs around £1,773 ($2,340).
The rift over remdesivir, sold as Veklury, by Gilead Sciences Inc., is the most serious.
Publishing updated treatment guidance in the BMJmedical journal, the panel acknowledged that their recommendation does not mean that remdesivir has no benefit for patients. "Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients". Plus, studies still haven't ruled out the possibility that remdesivir could cause "important harm" to patients, the World Health Organization wrote.
The WHO's recommendation, which is not binding, is part of its so-called "living guidelines" project, created to offer ongoing guidance for doctors to help them make clinical decisions about patients in fast-moving situations such as the COVID-19 pandemic. The groups say there isn't enough evidence to recommend for or against them.
"Clearly, now steroids are the standard of care", Howard Bauchner, editor-in-chief of the Journal of the American Medical Association, told The New York Times in September.