Switzerland announced Thursday that COVID-19 patients beyond those on clinical trials could be given remdesivir, the first drug shown to be relatively effective in treating the new coronavirus.
At least two major US studies have shown that the anti-viral drug can reduce the duration of hospital stays for those suffering from the novel coronavirus.
“With immediate effect, remdesivir can be used more widely in Switzerland for the treatment of COVID-19 patients,” the government said in a statement.
Following a swift review this week, Swissmedic, the national agency for therapeutic products, said it would allow the temporary distribution of the drug, which was originally intended as a treatment for Ebola.
“Products containing the active substance remdesivir and marketed under the brand name Veklury may be used in Swiss hospitals, without authorisation, for the treatment of COVID-19 patients,” the statement said.
The product will be made available to patients outside approved clinical trials and the approved compassionate use programme, pending a decision on full authorisation of the drug.
Clinicians will monitor any adverse reactions to the drug to ensure patient safety, the government said.
– Cases rising again –
Switzerland had largely got the virus under control, but, from a low and stable base, has witnessed a resurgence in cases in the last week or so.
The wealthy European nation, population 8.5 million, said in Thursday’s daily COVID-19 update that 31,884 people had tested positive for the new coronavirus since it was first detected in Switzerland in February.
Some 4,051 people have been hospitalised and 1,685 have died. Nearly 600,000 PCR tests for the virus have been conducted, with 6.4 percent proving positive.
The United States has bought up almost all the supply of remdesivir.
Washington announced this week that it had purchased 92 percent of all remdesivir production by the California-based Gilead laboratory until the end of September — about 500,000 treatments out of nearly 550,000. Each treatment requires 6.25 vials on average.
The World Health Organization’s emergencies director Michael Ryan said Wednesday that the Geneva-based UN agency was looking into procurement details.
“There are many people around the world who are very sick with this disease and we want to ensure that everybody has access to the necessary life-saving interventions,” he told a virtual briefing.
Britain and Germany said Wednesday they had sufficient stocks of remdesivir, the first drug to be shown to be relatively effective in treating COVID-19, and of which the United States has bought almost all supply.
The US government announced this week that it had bought 92 percent of all remdesivir production by the Gilead laboratory until the end of September — about 500,000 treatments out of nearly 550,000. Each treatment requires 6.25 vials on average.
President Donald Trump “has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19,” said Secretary of Health and Human Services Alex Azar.
The drug was approved in the United States on May 1 after clinical trials showing it reduced the recovery time for seriously ill COVID-19 patients by four days, and Europe is set to approve it soon.
Washington’s buy-up raised concerns about a shortage in the rest of the world, but at least two European countries said Thursday that they were not worried.
“The UK has been using remdesivir for some time, first in trials and now in the early access to medicines scheme. The UK currently has a sufficient stock,” the British Prime Minister’s spokesman said.
In Germany, a health ministry spokesman said “the government secured stocks of remdesivir early on for the treatment of corona patients. At the moment, there are sufficient reserves.”
The Gilead laboratory has indicated that it granted free licenses to nine manufacturers of generic drugs in India, Pakistan and Egypt, which will have the right to distribute their versions of remdesivir in 127 countries, mainly in Africa, Asia, the Middle East and Central America.
Gilead boss Daniel O’Day said in May that remdesivir made in the US could also be exported.
Experts say that worldwide production should increase to meet demand.
“If you are worried that you or a loved one will need this drug and it won’t be available if you are not in the US, I don’t think that will be the case (and I certainly hope not),” Farasat Bokhari, associate professor in economics at the University of East Anglia, said.
“Manufacturers in other countries are going to ramp up production. The only issue is how fast they can do it.”
The European Medicines Agency said Thursday it has recommended authorising the use of the anti-viral drug remdesivir to treat the new coronavirus.
“Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU,” the agency said.
It said the recommendation still needs approval from the European Commission, which is due to make a decision in the coming week.
At least two major US studies have shown that remdesivir can reduce the duration of hospital stays for COVID-19 patients.
Washington authorised the emergency use of the medicine — which was originally intended as a treatment for Ebola — on May 1, followed by several Asian nations including Japan and South Korea.
EMA’s human medicines committee said it has recommended granting a conditional marketing authorisation to remdesivir for the treatment of COVID-19 in adults and adolescents from 12 years of age who are suffering pneumonia and require extra oxygen.
It said its assessment was based mainly based on data from a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).
The research, published in the leading journal the New England Journal of Medicine in May, showed that injections of remdesivir speeded patient recovery compared with a placebo.
On average it reduced patients’ hospital stays from 15 days to 11.
One study published in The Lancet, however, found no “significant clinical benefit” from treating coronavirus patients with remdesivir.
“Taking into consideration the available data, the agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease,” the Amsterdam-based EU agency said.
Anti-viral drug remdesivir cuts recovery times in coronavirus patients, according to the full results of a trial published Friday night, three weeks after America’s top infectious diseases expert said the study showed the medication has “clear-cut” benefits.
Complete results from the research, which was carried out by US government agency the National Institute of Allergy and Infectious Diseases (NIAID), were published by leading medical periodical the New England Journal of Medicine.
The United States authorized the emergency use of remdesivir in hospitals on May 1, followed by Japan, while Europe is considering following suit.
The study found that remdesivir, injected intravenously daily for 10 days, accelerated the recovery of hospitalized COVID-19 patients compared to a placebo in clinical tests on just over a thousand patients across 10 countries.
On April 29, NIAID director Anthony Fauci, who has become the US government’s trusted face on the coronavirus pandemic, said preliminary evidence indicated remdesivir had a “clear-cut, significant and positive effect in diminishing the time to recovery.”
The National Institutes of Health, of which the NIAID is a part, said Friday in a statement online that investigators found “remdesivir was most beneficial for hospitalized patients with severe disease who required supplemental oxygen.”
But the authors of the trial wrote that the drug did not prevent all deaths.
“Given high mortality despite the use of remdesivir, it is clear that treatment with an anti-viral drug alone is not likely to be sufficient,” they said.
About 7.1 percent of patients given remdesivir in the trial group died within 14 days — compared with 11.9 percent in the placebo group.
However, the result is just below the statistical reliability threshold, meaning it could be down to chance rather than the capability of the drug.
As for Avigan, developed by Japanese firm Fujifilm Toyama Chemical, top government spokesman Yoshihide Suga said the government “aims to approve it this month” if a clinical trial involving 100 patients proves effective.
The drug, whose generic name is favipiravir, was approved for use in Japan in 2014 but only in flu outbreaks that are not being effectively addressed by existing medications.
It is not available on the market and can only be manufactured and distributed at the request of the Japanese government.
Favipiravir, which can be taken orally as a pill, works by blocking the ability of a virus to replicate inside a cell.
Remdesivir incorporates itself into the virus’s genome, short-circuiting its replication process.
Avigan has been shown in animal studies to affect fetal development, meaning it is not given to pregnant women.
The doctor who treated the first COVID-19 patient in the United States said Monday he fears a second outbreak of the disease when lockdown measures are lifted.
George Díaz’s first patient, diagnosed in January in Washington state, has already recovered after receiving remdesivir, an experimental drug that the US approved on Friday for emergency use.
While he feels encouraged by this anti-viral, Diaz emphasized that isolation to avoid contagion remains the “most effective” treatment for COVID-19 right now.
Since that first case in January, the US has overtaken all other countries to have by far the highest caseload — about 1.2 million — as well as the most deaths, around 69,000.
Despite forecasts of a worsening death toll, some states are already reopening to try to ease the economic strain of shelter-in-place orders that have put more than 30 million Americans out of work in six weeks.
“What worries me is that when the economy starts to reopen, we are going to see a second outbreak that is perhaps as big as the first, and the first one was very difficult for us and for the whole world,” Díaz told reporters during a video meeting organized by the State Department.
American authorities have approved an experimental drug for emergency use on coronavirus patients, as more US states eased pandemic lockdowns despite another spike in deaths from the disease.
The approval is the latest step in a global push to find viable treatments and a vaccine for the coronavirus, which has left half of humanity under some form of lockdown, hammered the world economy, and infected more than 3.3 million people.
Remdesivir, an antiviral drug initially developed to treat Ebola, was given the green light on Friday after a major trial found that it boosted recovery in serious COVID-19 patients.
“It’s really a very promising situation,” President Donald Trump said on Friday at the White House, where he was joined by Daniel O’Day, CEO of Gilead Sciences, which developed Remdesivir.
Remdesivir incorporates itself into the virus’s genome, short-circuiting its replication process.
The drug approval came as the US leaders struggled with growing pressure from citizens wearying of stay-at-home orders.
With about 1.1 million confirmed coronavirus cases, nearly 65,000 of them fatal, the United States has the highest tolls of any country, and Trump is keen for a turnaround as the world’s largest economy reels with tens of millions left jobless.
“Hopefully, we’re going to come in below that 100,000 lives lost, which is a horrible number nevertheless,” said Trump, after suggesting earlier in the week the country could expect 60,000 or 70,000 fatalities.
Texas became the largest US state yet to ease curbs, while anti-lockdown demonstrations were held in several states — including California, where officials had re-closed beaches beginning Friday to avoid a repeat of last weekend when crowds flocked to the shoreline.
There were protests in 11 cities in California — where more than 50,000 coronavirus cases have been reported — with people chanting against the lockdown.
In Huntington Beach, about 35 miles (55 kilometers) south of Los Angeles, several thousand people rallied to denounce Governor Gavin Newsom’s beach shutdown order.
“It was the straw that broke the camel’s back,” protester Monica Beilhard fumed.
“It was uncalled for, unnecessary and people out here are making that known,” she said. “And we’re also very much saying enough is enough, we have the right to work… and it’s time for the governor to allow the healthy to be able to get back to business.”
‘Slow, phased’ reopening
Like the United States, governments around the world are struggling to balance the immense political and economic pressure to ease lockdowns with the need for public health measures against the spread of the virus, which has killed more than 236,000 people.
Several European countries, including Austria, have begun to ease restrictions with authorities in some of the hardest-hit parts like Spain reporting signs that the pandemic there was slowing.
Britain announced that it had hit its target of conducting 100,000 coronavirus tests a day, a step toward eventually lifting lockdown rules in the UK — which this week overtook Spain to record the world’s third-highest death toll.
Ireland, however, extended its lockdown by two weeks to May 18, with Prime Minister Leo Varadkar saying the nation will reopen “in a slow, phased, staged way” after that.
Meanwhile in South Asia, India announced that the lockdown on its 1.3 billion people — the world’s biggest — would continue for two more weeks from May 4.
The virus restrictions also put a damper on May Day celebrations worldwide on Friday, with many labor unions delaying their rallies and some holding online events, while a determined few hit the streets in face masks in defiance of lockdown orders.
In Cuba’s capital Havana, where around a million workers and their families take part in the annual May Day march, the image of Che Guevara gazed down on an eerily silent Revolution Square.
May Day carried extra significance this year because of the staggering number of people put out of work by the pandemic, with the global economy in a tailspin and facing its worst downturn since the Great Depression.
Stock markets tumbled again on Friday after President Trump’s unproven allegation that the virus may have come from a lab in Wuhan — the central Chinese city where the disease first emerged late last year.
Beijing has rejected the accusation, and scientists believe the virus jumped from animals to humans.
The White House has accused Chinese authorities of mishandling the outbreak, “slow-walking” coronavirus data and putting US lives at risk.
The disease overwhelmed healthcare infrastructure when it hit the United States, putting immense pressure on doctors, nurses and emergency responders.
Some US medics relied on past experience in other countries to fight the virus.
David Callaway, a doctor and academic who has worked in the past on diseases in conflict-hit nations such as South Sudan and Iraq, said he found overseas epidemics easier to handle in some ways.
“Family and loved ones, you can put them in a box and you use them as a source of motivation and inspiration when things get rough, but you know they are safe,” he told AFP.
“A pandemic at home, you know that your family and your loved ones are still at risk, their lives hang on the line.”
The experimental antiviral drug remdesivir has failed in its first randomized clinical trial to treat the COVID-19 illness, reports said Thursday, quoting draft documents that were accidentally published by the World Health Organization.
Gilead Sciences, the company behind the medicine, disputed how the now deleted post had characterized the findings, saying the data showed a “potential benefit.”
The Financial Times reported that researchers in China carried out a study on 237 patients, giving the drug to 158 and comparing their progress with a control group of 79.
A summary of the experiment said remdesivir was “not associated with a difference in time to clinical improvement” compared to the control, according to health news site Stat, which posted a screenshot.
After a month, 13.9 percent of the patients on remdesivir had died compared to 12.8 percent of those in the control group.
A spokesman for Gilead told AFP: “We believe the post included inappropriate characterizations of the study,” saying it was terminated early due to low enrollment and was therefore not statistically meaningful.
“As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease,” he said.
The study does not represent the final word on the matter and there are several large-scale trials in advanced stages that should soon provide a clearer picture.
Remdesivir, which is administered intravenously, was among the first drugs mooted as a treatment for the novel coronavirus and as such has great hopes riding on it.
Last week, Stat reported it had shown significant efficacy at a Chicago hospital where patients who are part of one of the major trials are being treated.
The US National Institutes for Health also reported it had proven effective in a small experiment on monkeys.
Remdesivir belongs to a class of drugs that act on the virus directly — as opposed to controlling the abnormal and often lethal autoimmune response it causes.
It mimics one of the four building blocks of RNA and DNA and gets absorbed into the virus’s genome, which in turn stops the pathogen from replicating.