Fears mount over global shortage of coronavirus drug remdesivir

Fears mount over global shortage of coronavirus drug remdesivir as it is used to treat Trump after US bought much of the world’s supply

  • Trump’s physician confirmed he is being treated for Covid-19 with remdesivir
  • For all hospitalised patients, FDA has given emergency use of the anti-viral drug 
  • NHS doctors told to save drug for those ‘who have greatest capacity to benefit’
  • UK hospitals issued alert warning of ‘increased demand against available supply’

Fears are mounting over a global shortage of the coronavirus drug remdesivir, which is being used to treat Donald Trump after the US bought much of the world’s supply. 

The US President’s physician confirmed last night that Trump is being treated for the virus with the experimental anti-viral drug that was first developed to combat Ebola.

For all patients hospitalised with Covid-19, the US’ Food and Drug Administration (FDA) has given emergency-use of the intravenous antiviral drug sold by Gilead Sciences Inc, which has been shown to shorten hospital stays. 

But NHS doctors have been told not to give the drug to the most seriously ill patients, and to save it for those who ‘have the greatest capacity to benefit’. 

Liberal Democrat MP Munira Wilsom said: ‘With this pandemic causing so much pain, ministers have a duty to do everything they can to keep people safe and ensure no one is left behind. 

 US President Donald Trump, who is being treated for Covid-19 with the experimental drug remdesivir, walks to Marine One as he heads to Walter Reed Military Medical Center on Friday

Remdesivir, pictured, works to prevent the virus from copying itself within a patient’s body so it can’t spread further but scientists have not yet discovered how

‘Reports the NHS is already rationing remdesivir because it is in short supply is deeply troubling. It is made all the worse by the denial from the Department for Health.

‘People deserve to know he truth. While it is clear the Government failed to prepare properly for a pandemic, they must leave no stone unturned in getting it now.’   

The National Institutes of Health (NIH) found that patients being given the drug improved after 11 days, four days faster than those who didn’t receive the medication.

It works to prevent the virus from copying itself within a patient’s body so it can’t spread further but scientists have not yet discovered how.  

Before he was hospitalised, the president was also treated with an experimental antibody drug from Regeneron. 

The FDA issued an emergency use authorisation for remdesivir on May 1, in response to the preliminary results of the NIH study that were released at the end of April.  

The study found that the medication helped patients recover 31 per cent faster.  

According to Hackensack Meridian Health, initially only severely ill hospitalised COVID-19 patients were eligible to be treated with remdesivir. 

On August 28, however, the FDA extended its authorisation to all hospitalised adult and paediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

Meanwhile, NHS hospitals around the country were issued an alert on Thursday titled ‘supply disruption’ which warned of an ‘increased demand against available supply’, telling doctors to be more selective about to whom they give the drug.

Marine One lifts off from the White House in Washington to carry President Trump to Walter Reed National military Medical Center. Trump will spend a ‘few days’ at the hospital

White House Chief of Staff Mark Meadows, right, watches as Trump walks off Marine One while arriving at Walter Reed Medical Center in Bethesda, Maryland, on Friday

WHAT IS REMDESIVIR AND DOES IT WORK AGAINST CORONAVIRUS?

Remdesivir, an anti-viral drug first made to try and treat Ebola, has been used experimentally on COVID-19 patients since the outbreak’s early days.

The FDA issued an emergency use authorization for the drug on May 1, in response to the preliminary results of a notable study that was released at the end of April.  

According to Hackensack Meridian Health, initially only severely ill hospitalized COVID-19 patients were eligible to be treated with remdesivir, otherwise known as Veklury.  

On August 28, the FDA extended its authorization to all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

‘The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients. The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,’ said FDA Commissioner Stephen M. Hahn, M.D. 

‘We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.’ 

However in August, a report from the drug’s California-based maker, Gilead Sciences Inc found that the effects of the medication may only be seen in those with severe infections. 

There are claims of miraculous recovery, improved survival odds and shorter illness, but other studies have found it makes no difference to patients in hospital with Covid-19.

Remdesivir produced encouraging results earlier this year when it showed promise for both preventing and treating MERS – another coronavirus – in macaque monkeys. 

The drug appears to help stop the replication of viruses like coronavirus and Ebola alike. 

It’s not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself. 

That, in turn, stops the virus from being able to proliferate further inside the patient’s body.   

The Department of Health denies there is a shortage of the drug, claiming there ‘remain plenty of supplies’, but said it was being used up faster and more stocks couldn’t be delivered until the end of October. It is not clear how much of the medicine the UK has bought.

The US, where remdesivir manufacturer Gilead is based, was criticised in June for buying up the entire global supply of the drug meaning no new orders could be placed for the three months following. As well as this, Gilead donated 1.5million doses of it for clinical trials around the world, further depleting supplies.

Britain is not alone in feeling the impact of the stocking issue, however, and hospitals in India are struggling to get hold of the drug, too.

Hospitals were advised to ration use of the drug in an emergency alert and were told the restrictions were likely to remain in place until at least the end of this month. 

The alert ordered staff to deny remdesivir to the most seriously ill patients, including those on ventilators, demanding it should only be given to people with the ‘greatest capacity for benefit’.

It said: ‘Due to increased demand against available supply, clinicians are now asked to apply the full eligibility criteria … last published on 3rd September 2020…

‘Clinicians are also asked to adhere to a standard treatment course of 5 days.’

It says that for people to be eligible for remdesivir they should be in hospital with Covid-19 and pneumonia but not using a ventilator.

‘The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients. The data to support today’s action are encouraging’, said FDA Commissioner Stephen M. Hahn, M.D in August.

‘The data show that this treatment has the potential to help even more hospitalised patients who are suffering from the effects of this devastating virus.

‘We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.’

Yet the same month, a report from the drug’s California-based maker Gilead found that the effects of the medication may only be seen in those with severe infections.

Researchers found a group of patients given the drug for five days saw their conditions improved but a similar group who received the drug for an average of six days had no significant benefit. 

The team looked at 584 patients with moderate cases of Covid-19. 

One third of the patients received a five-day course, one-third received a 10-day course and the remaining were given standard care. 

The patients were at 105 hospitals in the US, Europe, and Asia, and were followed for a little less than two weeks.

The median length of treatment was five days for patients in the five-day remdesivir group and six days for patients in the 10-day remdesivir group. 

Those treated with remdesivir for five days were much better by day 11 than the standard care group, but the authors said this ‘was of uncertain clinical importance.’

Remdesvir is approved in the US for emergency use in patients hospitalized with COVID-19. Pictured: A vial of remdesivir at the University Hospital Eppendorf in Hamburg, Germany

However, the group that received the drug for an average of six days did not differ from standard care group

What’s more, death rates didn’t vary between the 10-day group and those who didn’t get the treatment with two percent in each group dying.  

Researchers say that patient receiving remdesivir did have fewer severe symptoms of the virus, they had more moderate symptoms and side effects such as headache and nausea.

The team says its not sure why there was such a difference but plant to evaluate these discrepancies in further trials. 

Remdesivir produced encouraging results earlier this year when it showed promise for both preventing and treating MERS – another coronavirus – in macaque monkeys.

It was developed to treat Ebola, the deadly fever that emerged in West Africa in 2014.

While it was unsuccessful in treating Ebola, the drug appears to interfere with the ability of the coronavirus to copy its genetic material.  

It’s not entirely clear how the drug accomplishes this feat, but it seems to stop the genetic material of the virus, RNA, from being able to copy itself.

That, in turn, stops the virus from being able to proliferate further inside the patient’s body.

Gilead announced in September that is looking to expand the ways that remdesivir might be used. 

Its CEO Daniel O’Day told CNBC’s Squawk Box on Monday that the company has launched trials to use the drug in IV form outside of hospitals.  

White House physician Sean Conley said on Friday night the president was ‘doing very well’

President Trump tweeted on Friday night that he believed his treatment was ‘going well’

Many major hospitals in the US are reserving the use of remdesivir for the sickest patients and have cut their orders by a third. 

At $3,120 per treatment course, remdesivir is expensive, and hospitals are reticent to buy or the drug on hand when it may go unused as hospitalizations for Covid-19 continue to decline in many states. 

O’Day said his company is ‘not done with remdesivir yet’ and is also trialling an inhaled form of the antiviral. 

In August, researchers want to see if adding another drug could improve the effects of remdesivir and shorten recovery time even further, reported The New York Times.

Beta interferon, currently approved to treat multiple sclerosis, also has anti-inflammatory properties and helps tame the immune system response, which may help tame a deadly overreaction the immune system has to the virus 

The trial is the third phase of the Adaptive Covid-19 Treatment Trial (ACTT), being run by the NIH’s National institute of Allergy and Infectious Diseases. 

The first phase of the study was the phase that helped remdesivir receive emergency use authorisation as a treatment for severe coronavirus patients.

The second phase tested remdesivir and a placebo in comparison with remdesivir and baricitinib, an arthritis drug that helps suppress inflammation, according to The Times.

Researchers are still evaluating the results, but it appears baricitinib did not quell cytokine storms, which occur when the body doesn’t just fight off the virus but also attacks its own cells and tissues.  

US BOUGHT ALMOST ENTIRE GLOBAL SUPPLY OF REMDESIVIR IN JUNE 

Boris Johnson was forced in July allay fears of an anti-coronavirus drugs shortage today after Donald Trump bought up almost the entire global supply of remdesivir.

The US president was accused of ‘undermining’ the global coronavirus fight by splashing the cash on one of only two drugs approved to treat Covid-19 at the time.

UK business minister Nadhim Zahawi was among those who criticised his decision to make the rest of the world compete for the medication, originally designed to treat Ebola but proven to speed up recovery time for coronavirus patients. 

But Downing Street and the Department of Health later played down the significance of the move, insisting that the UK has enough of a stockpile to treat everyone who needs it. 

The Prime Minister’s official spokesman said on July 1: ‘The UK currently has a sufficient stock of Remdesivir.’ 

And the Department of Health said it had secured supplies in advance and had enough to treat every NHS patient who needs it. 

The US Department of Health and Human Services (HSS) had earlier revealed  it had secured more than 500,000 treatment courses of remdesivir for American hospitals. 

It represents the entire global supply for July and 90 per cent of stocks for August and September, leading to fears of an autumn shortage.

Discussing the deal — which US health chiefs boasted was ‘amazing’ — Mr Zahawi told Sky News: ‘It’s much better to work together than to work to undermine each other, so we’ll continue in that spirit.’ 

After Trump’s hospitalisation, White House physician Sean Conley said in a letter to Press Secretary McEnancy that Trump began taking the drug on Friday night. 

‘This afternoon, in consultation with specialists from Walter Reed and Johns Hopkins University, I recommended movement of the President up to Walter Reed Military Medical Center for further monitoring,’ Conley wrote. 

‘This evening I am happy to report that the President is doing very well. He is not requiring any supplemental oxygen, but in consultation with specialists we have elected to initiate remdesivir therapy. He has completed his first dose and is resting comfortably.’ 

Trump also tweeted that he believed his treatment was ‘going well’ on Friday night. 

Earlier on Friday, the president had been treated with an experimental antibody drug that has been called one of the most promising approaches to preventing serious illness from a Covid-19 infection.

Its maker, Regeneron Pharmaceuticals, said the company agreed to supply a single dose, given intravenously, for Trump at the request of his physician under ‘compassionate use’ provisions. 

The new drug is in late-stage testing and its safety and effectiveness are not yet known, and no treatment has yet proven able to prevent serious illness after a coronavirus infection. 

Trump was given the experimental drug at the White House on Friday before he was taken to Walter Reed National Military Medical Centre.

Several doctors who treat Covid-19, including Dr David Boulware at the University of Minnesota, had speculated that doctors might use the antibody drug, given that this approach has worked against other diseases in the past.

‘They’re not going to just sit around and watch to see if he gets sick,’ he said.

Antibodies are proteins the body makes when an infection occurs and vaccines trick the body into thinking there is an infection so it makes these antibodies.

But it can take weeks for them to form after natural infection or a vaccine.

The drugs aim to give that protection immediately, by supplying concentrated versions of one or two antibodies that worked best against the coronavirus in laboratory and animal tests.

Regeneron’s drug contains two antibodies to enhance chances that it will work and the company previously developed a successful Ebola treatment from an antibody combination. 

A scientist works in Regeneron Pharmaceuticals’ Infectious Disease Lab in New York state, for efforts on an experimental coronavirus antibody drug. Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help the immune system eliminate it

Earlier this week, Regeneron said partial results from about 275 Covid-19 patients who were not sick enough to need hospital treatment suggested it might be cutting how long symptoms last.

However, the study has not been completed, the results were only announced in a company news release and have not been published or reviewed by other scientists. 

On Friday, Conley said Trump also was taking zinc, vitamin D, an antacid called famotidine, melatonin and aspirin. None of those have been proven to be effective against Covid-19.

Trump apparently is not receiving hydroxychloroquine, a drug he widely promoted that has been shown in many studies to be ineffective for preventing or treating Covid-19.

The president announced he and the First Lady Melania Trump tested positive for coronavirus in the early hours of Friday morning. 

The White House said he will be spending a ‘few days’ in hospital but will continue to work.  

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