Tag Archives: WHO

U.S. infectious disease group backs Gilead’s remdesivir for COVID-19 treatment

By Rebecca Spalding

(Reuters) – The top U.S. infectious disease medical association said on Monday that Gilead Sciences Inc’s antiviral drug remdesivir should be used for hospitalized COVID-19 patients despite a World Health Organization (WHO) recommendation last week against its use.

The Infectious Diseases Society of America (IDSA) in updated guidelines said its experts back the drug for use in severe COVID-19 patients based on a clinical trial showing it reduced hospital stays. The WHO study that led to its recommendation against the drug suggested it had no benefit in saving lives or reducing the need for mechanical breathing assistance.

“As hospitals around the United States fill up, the IDSA panel views the effect of remdesivir speeding up time to recovery to be an important benefit,” Dr. Rajesh Gandhi, co-chair of the society’s COVID-19 treatment and management guidelines expert panel, said on a call with reporters. “Better medicines that improve survival are clearly needed.”

Unlike the trial that led to its U.S. regulatory approval, the WHO’s study was not placebo-controlled. Studies with a placebo comparison are generally considered more scientifically rigorous than those without a control group.

The IDSA also has advised against the routine use of Eli Lilly and Co’s COVID-19 antibody treatment bamlanivimab, which received U.S. emergency use authorization. The IDSA panel said it recommended against its routine use for ambulatory patients, but that it may still be appropriate for patients with increased risks after a discussion with their doctor.

“Antibodies may end up having a role. I think we just need more definitive data,” Dr. Gandhi said. “I want to keep our eye on what benefit they may end up having as well as which patients are most likely to benefit.”

It said Roche Holdings Ag’s rheumatoid arthritis drug Actemra, known chemically as tocilizumab, is not recommended for routine use in hospitalized COVID-19 patients, saying there was still not enough evidence supporting its benefits.

(Reporting by Rebecca Spalding; Editing by Bill Berkrot)

Travel restrictions challenge vaccine rollout, airlines warn

PARIS (Reuters) – Air cargo operators may struggle to distribute new COVID-19 vaccines effectively unless pandemic travel restrictions are eased, global airlines cautioned on Monday.

The warning came in vaccine transport guidelines issued by the International Air Transport Association (IATA), which is pushing governments to replace travel curbs and quarantines with testing.

“If borders remain closed, travel curtailed, fleets grounded and employees furloughed, the capacity to deliver life-saving vaccines will be very much compromised,” the IATA document said.

Moderna Inc. said on Monday its experimental COVID-19 vaccine had proved 94.5% effective in a clinical trial, a week after rival drugmaker Pfizer reported 90% efficacy findings for its vaccine. Once approved, both vaccines are likely to require transport and storage well below freezing, posing logistical hurdles.

Widespread grounding of passenger flights that normally carry 45% of global cargo in their holds has taken out capacity, thinning the air freight network and driving up prices.

Existing immunization campaigns have struggled with the partial shutdown. The World Health Organization and UNICEF “have already reported severe difficulties in maintaining their planned vaccine programs during the COVID-19 crisis due, in part, to limited air connectivity,” IATA said.

Vaccines will need to be shipped to developing countries reliant on passenger services for cargo, IATA’s head of cargo Glyn Hughes told Reuters. Even in industrialized states, vaccine dispersal may be a tighter bottleneck than production, requiring shipments to secondary airports on passenger jets.

In preparation for the challenge of mass vaccine distribution, governments should move to reopen key passenger routes backed by robust testing, the airline body argues.

“There are several more months for governments to go through the planning cycle,” Hughes said, leaving enough time to “get passenger networks safely resumed, looking at safe travel corridors (and) mutual acceptance of testing procedures.”

(Reporting by Laurence Frost; editing by David Evans)

Measles surging as COVID-19 curbs disrupt vaccinations

By Kate Kelland

LONDON (Reuters) – Measles surged to infect almost 870,000 people across the world in 2019, the worst figures in almost a quarter of a century as vaccination levels fell below critical levels, a report said on Thursday.

Millions of children are at risk of the disease again this year as restrictions imposed to contain the COVID-19 pandemic further disrupt immunization programs, the report co-led by the World Health Organization (WHO) said.

Measles is one of the most contagious known diseases – more so than COVID-19, Ebola, tuberculosis or flu.

More than 207,000 people died of it last year alone, the report found. With immunization coverage below the critical 95% needed for community protection, infections rose in all WHO regions last year to the worst levels since 1996, it said.

“These data send a clear message that we are failing to protect children from measles in every region of the world,” the WHO’s Director-General, Tedros Adhanom Ghebreyesus, said in a statement.

The surge in fatal cases means global measles deaths have risen nearly 50% since 2016.

The report, co-led by the United States Centers for Disease Control and Prevention (CDC), cited a collective failure to fully immunize children on time with two doses of measles vaccine as the main driver of the deadly increases.

Looking ahead to 2020, the report warned that disruptions to vaccination due to the COVID-19 pandemic have crippled efforts to curb measles outbreaks.

As of this month, more than 94 million people were at risk of missing measles vaccinations due to paused immunization campaigns in 26 countries, it said.

“COVID-19 has resulted in dangerous declines in immunization coverage,” Seth Berkley, chief executive of the GAVI global vaccine alliance, said.

He described the “alarming” measles report was “a warning that, with the COVID-19 pandemic occupying health systems across the world, we cannot afford to take our eye off the ball.”

After steady downward progress from 2010 to 2016, measles cases began rising again from 2017. The report said there were a total of 869,770 measles cases, with 207,500 deaths, in 2019.

WHO and the UN children’s fund UNICEF urged governments last week to act now to prevent epidemics of measles, polio and other infectious diseases.

(Reporting by Kate Kelland, editing by Andrew Heavens)

Explainer – Shot in the dark: Early COVID-19 vaccine efficacy explained

By John Miller

ZURICH (Reuters) – This week has seen a flurry of good news from COVID-19 vaccine developers, with Pfizer Inc. and BioNTech SE trumpeting early data indicating their mRNA candidate is more than 90% effective.

A Russian project came out a day later, touting 92% efficacy for the Sputnik V candidate, named after the Soviet-era satellite, based on a smaller data set.

HOW DO MANUFACTURERS ARRIVE AT EFFICACY NUMBERS?

In Pfizer’s case, it waited until 94 volunteers in its late-stage clinical trial of more than 43,500 people – half got the vaccine, the other half got a placebo – tested positive after developing symptoms.

For 90%-plus efficacy, no more than eight people among those who tested positive had received the vaccine, with the rest having received the placebo.

“Roughly speaking, it’s probably around eight to 86 cases in the treated and placebo groups,” David Spiegelhalter, a Cambridge professor of risk and an expert in statistics, told Reuters.

“You don’t need a lot of fancy statistical analysis to show that this is deeply impressive. It just hits you between the eyes.”

In Russia, Sputnik V-developer Gamaleya Institute reached its preliminary 92% efficacy figure based on 20 illnesses in 16,000 volunteers as its late-stage trial progresses. It aims to reach 40,000 people.

Of the 16,000 people, about quarter got the placebo.

“It suggests that there is some effect, but it’s insufficient to estimate the magnitude of it,” Spiegelhalter said.

HOW MANY PEOPLE MUST GET SICK IN BIG VACCINE TRIALS?

Some experts say that, ideally, 150 to 160 people in a trial of tens of thousands of participants must get sick before making a reliable assessment of a vaccine’s efficacy. That’s a bit of a rule of thumb, though, open to interpretation.

“There is no such regulatory standard requiring X number of events for making a reliable decision,” the government-funded Swiss Clinical Trial Organization said. “The amount of (infections) has to be seen in relation to the disease and its risk profile. It’s rather a case-by-case evaluation.”

Typically, regulators strive to have at least 95% certainty that the trial read-out is not the result of random variations with nothing to do with the tested compound.

For trial sponsors there is safety in numbers as a large enough trial can ensure that 95% reliability hurdle is cleared. But the larger the underlying clinical benefit, the fewer trial participants needed to create that clarity.

In Pfizer and BioNTech’s trial, they planned a final analysis when 164 people had become sick, with multiple, pre-planned interim analyses along the way. They skipped an analysis at 32 patients, and once they were ready to release a look at the 62-person mark, 94 had come down sick.

Details from the Russian trial are unclear, without access to its protocol.

HOW DO THESE RESULTS STACK UP TO OTHER DRUGS, OR VACCINES FOR OTHER ILLNESSES?

In normal drug trials, for diseases like terminal cancer, benefits of new medicines may be less apparent, with survival benefits of just a few months sometimes revolutionary for patients at death’s door.

For vaccines, however, marginal protection is inadequate, and the World Health Organization ideally wants to see at least 70% efficacy in trials, while the U.S. Food and Drug Administration wants at least 50%.

The 90% efficacy reported in the Pfizer and Russian trials beats those, and appears to exceed that of typical flu vaccines, which the U.S. Centers for Disease Control and Prevention (CDC) estimate reduce the risk of sickness by 40%-60%.

For other shots, the CDC estimates the efficacy of a two-shot measles vaccine at 97%, and a two-dose chicken pox vaccine at 90%. Two doses of polio vaccine are 90% effective, rising to nearly 100% with a third.

CAN WE EXPECT EFFICACY RATES TO HOLD UP AS TRIALS ADVANCE?

Pfizer acknowledged on Monday that its final vaccine efficacy percentage may vary. Still, Spiegelhalter said the study’s design seems likely to generally hold up, based on the 94 sick participants.

“In this case, the effect is so huge, even if there is a little bit of fallback – if the effects become slightly smaller over time – that is very unlikely to be significant.”

WHAT ABOUT REAL-WORLD EFFICACY, SHOULD THE VACCINES BE APPROVED?

The interim data is promising, since it appears to demonstrate that a vaccine can be effective in preventing COVID-19.

The jump to mass vaccinations, however, presents new hurdles, in particular for an mRNA vaccine like Pfizer and BioNTech’s that must be stored and shipped at minus 70 degrees Celsius (-94°F).

Moreover, the Pfizer-BioNTech vaccine requires two doses, ideally 21 days apart. If people do not stick to the timetable, it may affect the vaccine’s efficacy.

Protection against the mumps, for instance, drops from nearly 90% to 78%, if people don’t get a follow-up shot.

Swiss epidemiologist Marcel Tanner, president of Switzerland’s Academies of Arts and Sciences and one of the government’s top COVID-19 science advisers, expects possible variations in efficacy among older people, whose immune systems wane with time, or those with immune disorders.

“Efficacy says, ‘Does it work?’ Effectiveness says, ‘Can it be applied? Can you carry the efficacy to the people?'” Tanner said. “But no question: 90% efficacy, at that stage, is a pretty good result.”

(Reporting by John Miller in Zurich, Kate Kelland in London, Ankur Banerjee in Bengaluru, Julie Steenhuysen in Chicago and Polina Ivanova in Moscow; Editing by Josephine Mason and Nick Macfie)

In blow to WHO, EU seeks powers to declare health emergencies

By Francesco Guarascio

BRUSSELS (Reuters) – The European Commission on Wednesday proposed rules which would give the EU the power to declare a health emergency and stress test national plans to tackle pandemics, in a potential blow to the World Health Organization.

The move follows an often uncoordinated reaction by the 27 EU governments to the COVID-19 pandemic, which at the beginning of the crisis led to competition on vital medical gear and export bans on medicines.

It also comes after the WHO was criticized for having declared the pandemic, which first emerged in China at the end of last year, too late. The U.N. agency has repeatedly denied the accusation.

Under the proposals, the EU would be able to declare an EU-level public health emergency, which would in turn trigger more coordination among EU states.

Currently, the EU relies on the WHO to declare such an emergency.

“The new rules will enable the activation of EU emergency response mechanisms (..) without making it contingent upon the WHO’s own declaration of a Public Health Emergency of International Concern,” an EU document says, adding that such a move would be coordinated with the WHO.

If adopted, the overhaul would partly take away a major power from the WHO, as EU states call for reform of the organization to address shortfalls in emergencies.

“We relied too much on the WHO for the COVID-19 pandemic,” Peter Liese, a top EU lawmaker from German Chancellor Angela Merkel’s party, said.

“Under pressure from China, the WHO declared the health emergency too late. It is therefore very important to have the possibility to act at European level in future similar situations.”

The WHO, which the Trump administration has labelled a puppet of China, was not immediately available to comment.

COORDINATION ON VACCINES

Under the commission’s proposals, the EU would help governments prepare pandemic plans and would audit and stress test them, an EU document says.

EU states have traditionally been reluctant to give more powers to Brussels on the matter.

During the pandemic, they have applied different national measures on a series of issues, including testing policies for COVID-19 cases, quarantine rules and travel restrictions.

But they have shown good coordination on procuring vaccines.

If approved by EU governments and EU lawmakers, the commission said the proposals would be immediately applicable and could strengthen EU powers to tackle the current pandemic, in which most European countries are seeing a surge in cases.

Brussels wants to strengthen the EU public health agency, the European Centre for Disease Prevention and Control, whose non-binding advice, such as on the length of quarantine after contact with an infected person, has often been ignored.

It also wants more power for the EU Medicines Agency to prevent risks of shortages of medicines and medical devices.

Brussels also said it would unveil by the end of next year plans for a new health authority modelled after the U.S. Biomedical Advanced Research and Development Authority, which has played a vital role in procuring experimental dugs and vaccines.

(Reporting by Francesco Guarascio @fraguarascio; Editing by Alison Williams and Nick Macfie)

U.S. denounces terms for WHO-led inquiry into COVID origins

By Stephanie Nebehay

GENEVA (Reuters) – The United States, which has accused China of having hidden the extent of its coronavirus outbreak, called on Tuesday for a “transparent and inclusive” WHO-led international investigation into the origin of the pandemic, criticizing its current terms.

The Trump administration has accused the World Health Organization of being “China-centric” and of being its puppet, which WHO director-general Tedros Adhanom Ghebreyesus has denied.

The virus, known as SARS-CoV-2, is believed to have emerged in the Chinese central city of Wuhan late last year, possibly from bats at a market with live animals.

Chinese scientists are carrying out research into its origins and how it jumped the species barrier. A WHO-led international team formed in September is to develop plans for longer-term studies building on China’s findings, according to the WHO’s published terms of reference.

Garrett Grigsby, head of the global affairs office at the U.S. Department of Health and Human Services, told the WHO’s ministerial assembly that member states had been informed of the investigation’s terms of reference only a few days ago.

The terms were “not negotiated in a transparent way with all WHO member states” and “the investigation itself appears to be inconsistent” with its mandate, he said, without elaborating.

“Understanding the origins of COVID-19 through a transparent and inclusive investigation is what must be done to meet the mandate,” Grigsby said.

Britain called for prioritizing the probe, adding: “We expect the investigation and its outcomes to be grounded in robust science.”

Sun Yang, of China’s National Health Commission, did not mention the investigation in his speech on Tuesday, but said that China supports “WHO’s continued leadership role”.

German Health Minister Jens Spahn, speaking for the European Union on Monday, called for “full transparency and cooperation” during all phases of the investigation.

WHO’s top emergency expert Mike Ryan said on Oct. 30 that the WHO-led team and its Chinese counterparts had held a first virtual meeting regarding joint investigations and would deploy on the ground in time.

A separate independent panel said on Tuesday it was working to establish “an accurate and authoritative chronology” behind the first outbreaks and responses. Former New Zealand Prime Minister Helen Clark and former Liberian President Ellen Johnson Sirleaf were named in July to co-lead the WHO panel.

Trump announced a temporary halt to U.S. funding to the WHO in April, prompting condemnation from many world leaders. The United Nations said in July it had received formal notification of the U.S. decision to leave the body next year.

(Reporting by Stephanie Nebehay; Editing by Catherine Evans and Nick Macfie)

WHO chief looks forward to working ‘very closely’ with Biden team

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – The World Health Organization chief welcomed efforts on Monday to strengthen the Geneva-based body through reform and said that it was looking forward to working closely with the administration of U.S. President-elect Joe Biden.

WHO’s funding must become more flexible and predictable to end a “major misalignment” between expectations and available resources, WHO director-general Tedros Adhanom Ghebreyesus said, citing reform efforts by France, Germany and the European Union.

“We still have a lot of work left to do, but we believe that we’re on the right track,” Tedros told health ministers as the annual meeting resumed of the WHO, which groups 194 countries.

U.S. President Donald Trump has frozen U.S. funding to the WHO and begun a process that would see the United States withdraw from the body next July, drawing wide international criticism amid the COVID-19 crisis. He accuses the WHO of being “China-centric” in its handling of the pandemic, which Tedros has repeatedly denied.

Biden, who will convene a national coronavirus task force on Monday, said during campaigning he would rescind Trump’s decision to abandon the WHO on his first day in office.

Tedros urged the international community to recapture a sense of common purpose, adding: “In that spirit we congratulate President-elect Joe Biden and Vice President-elect Kamala Harris and we look forward to working with this administration very closely.

“We need to reimagine leadership, build on mutual trust and mutual accountability to end the pandemic and address the fundamental inequalities that lie at the root of so many of the world’s problems,” he said.

An oversight panel called last week for reforms at the WHO including “predictable and flexible” funding and setting up a multi-tiered system to warn countries earlier about disease outbreaks before they escalate.

Tedros, speaking from quarantine after being in contact with an individual with COVID-19 more than a week ago, began with a minute’s silence, noting that COVID-19 cases approached 50 million with 1.2 million deaths.

Speaking shortly before Pfizer Inc said its experimental COVID-19 vaccine was more than 90% effective, Tedros said vaccines being developed to curb the pandemic should be allocated fairly as “global public goods, not private commodities”.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Catherine Evans)

Exclusive: WHO-led COVID drug scheme doubles down on antibodies, steroids and shuns remdesivir

By Francesco Guarascio

BRUSSELS (Reuters) – A World Health Organization-led scheme to supply COVID-19 drugs to poor countries is betting on experimental monoclonal antibody treatments and steroids but is shunning Gilead’s remdesivir blockbuster therapy, an internal document shows.

The WHO draft document, seen by Reuters and dated Oct. 30, says the priorities are to secure monoclonal antibodies in a tight market and to boost purchases and distribution of cheap steroid dexamethasone, of which it has already booked nearly 3 million courses of treatment for poorer countries.

Monoclonal antibodies are manufactured copies of antibodies created by the body to fight an infection.

The paper, which for the first time outlines how the scheme would spend donors’ money, does not cite remdesivir among priority drugs – a significant omission as the antiviral is the only other medication alongside dexamethasone approved across the world for treating COVID-19.

Gilead Science, the U.S. company that developed remdesivir, said the WHO scheme had not funded its COVID-19 trials and had never approached the firm for the possible inclusion of the drug in its portfolio.

The drug-supply scheme is one of the four pillars of the so-called ACT Accelerator, a WHO-led project which also seeks to secure COVID-19 vaccines, diagnostics and protective gear for poorer countries by raising more than $38 billion by the beginning of 2022.

“Immediate priorities for the (therapeutics) pillar are intensifying efforts on monoclonal antibodies while scaling up dexamethasone use,” says the WHO document, still subject to changes and expected to be published on Friday or next week.

The drug-supply scheme, co-led by the Wellcome Trust, a charity, and Unitaid, a health partnership hosted by the WHO, urgently needs $6.1 billion, $750 million of which by February, out of a total ask of $7.2 billion.

More than half the money needed urgently would be used to procure and distribute monoclonal antibodies, the document shows, saying these therapeutics could have a “game-changing” impact but are in short supply.

No drug based on monoclonal antibodies has yet been approved against COVID-19, but the WHO scheme has already invested in research on the new technology and has secured production capacity at a plant of Fujifilm Diosynth Biotechnologies in Denmark.

Fujifilm was not immediately available for a comment.

The scheme wants to spend $320 million to produce antibodies in that facility, the document says, estimating that would be enough to secure at least 4 million antibody courses assuming upper-range procurement costs of $80 per course.

A spokeswoman for Unitaid, speaking on behalf of the co-leaders of the scheme, confirmed that it wanted to raise and invest $320 million in securing monoclonal antibodies but declined to comment on potential commercial deals citing confidential agreements.

Another $110 million would be used for regulatory approval and other market preparation procedures for monoclonal antibodies in poorer countries, the document shows, while $220 million would fund clinical trials of monoclonal antibodies and COVID-19 drugs projects in poorer countries.

Among companies developing monoclonal antibodies against COVID-19 are U.S. pharmaceutical giant Eli Lilly, Switzerland’s Novartis and U.S. firm Regeneron, whose antibodies were administered together with remdesivir to U.S. President Donald Trump in October when he tested positive for the coronavirus.

Eli Lilly has already agreed to produce antibodies at the Fujifilm plant from April and make them available at “an affordable price” to poorer countries, a company spokeswoman said.

Lilly’s drug is being trialed and is seeking emergency authorization in the United States.

A U.S. government-run trial of the drug was paused in mid-October over safety concerns, but other trials continue. In spite of the suspension, the U.S. administration said last week it had sealed a $375-million supply deal.

It is unclear how and whether the WHO scheme will raise the money needed for the supply of antibodies and other projects.

Regeneron was not immediately available for comment.

Novartis, which expects results soon from a trial of its arthritis treatment canakinumab against COVID-19, said on Thursday that it received a request several days ago from the WHO scheme seeking information about medicines to tackle the coronavirus. Novartis also makes dexamethasone.

REMDESIVIR? NO, THANKS

Despite being short of funds, the WHO drugs-supply scheme wants to “transform the treatment landscape”, the document says, and distribute hundreds of millions of courses of COVID-19 drugs to poorer countries by 2022.

Apart from monoclonal antibodies and dexamethasone, it is also planning to develop and secure experimental drugs, including new antivirals and repurposed drugs.

The scheme wants to spend another $100 million to seal deals with unspecified drugmakers from mid-2021, the document says, and next year plans to invest another $4.4 billion to secure drugs showing positive results in clinical trials.

The Unitaid spokeswoman said that among repurposed therapeutics, dexamethasone and its alternative, hydrocortisone, were the most promising.

Remdesivir, alternatively known as Veklury, is also a repurposed antiviral which was initially trialed against Ebola.

Unitaid confirmed the scheme had not procured or funded remdesivir. It did not comment on whether it may buy the drug in future or on why remdesivir did not appear among priority treatments in the document.

Remdesivir has been authorized in dozens of countries around the world to treat COVID-19. However, preliminary findings of a major WHO-sponsored trial revealed in October the antiviral had little or no benefit for COVID-19 patients, contradicting previous positive trials.

Governments however continue to buy it, with Germany this week announcing the purchase of more than 150,000 doses for the next six months.

(Reporting by Francesco Guarascio @fraguarascio; additional reporting by John Miller in Zurich and Caroline Humer; editing by Nick Macfie)

EU urged to review remdesivir supply deal after COVID trial results

By Francesco Guarascio

BRUSSELS (Reuters) – The European Union should renegotiate a 1 billion euro ($1.17 billion) contract it sealed last week with Gilead for a six-month supply of the COVID-19 drug remdesivir after it showed poor results in a large trial, experts said on Friday.

In a blow to one of the few drugs being used to treat people with COVID-19, the Solidarity Trial conducted by the World Health Organization showed on Friday that remdesivir appeared to have little or no effect on mortality or length of hospital stays among patients with the respiratory disease.

The trial results were disclosed a week after the EU’s executive Commission announced its largest contract to date with Gilead for the supply of 500,000 courses of the antiviral drug at a price of 2,070 euro per treatment, which Gilead said was the standard for wealthy nations.

The Commission “needs to present the reasons behind the rush to conclude the latest contract with Gilead and move to review it in light of the Solidarity Trial findings,” said Yannis Natsis, who represents patients’ organizations on the board of the European Medicines Agency (EMA), the EU drug regulator.

The EU announced on Oct. 8 that it had signed the supply contract with the U.S. company on behalf of its 27 member states and 10 partner countries, including Britain.

Gilead had known about the results of Solidarity since Oct. 6, the WHO said, citing disclosure rules under the Solidarity Trial.

Gilead told Reuters it had received in late September an “heavily redacted manuscript” from the WHO which contained different information from the final document published on Friday.

“TIME IS OF THE ESSENCE”

The Commission’s decision was made after EU countries warned of shortages of remdesivir in their hospitals amid a new surge of COVID-19 infections across Europe.

The contract does not oblige countries to buy remdesivir, although it ties them to the agreed price.

Gilead did not comment on whether remdesivir’s price for wealthy countries could change after the WHO trial, and the company questioned its results.

“As time is of the essence – we are in a situation of a public health emergency – we have to not only invest up-front in vaccine development but also in access to therapeutics,” a spokesman for the European Commission said.

He added the EMA would look into the Solidarity results and data available from other studies on COVID treatments “to see if any changes are needed to the way these medicines are used”.

But the spokesman did not comment on whether the EU was aware of the Solidarity results before it signed the contract with Gilead. He also did not reply to questions on whether the price agreed with Gilead could be renegotiated.

“The EU should revisit the prices to be paid for Remdesivir. Why pay 1 billion euros for a drug with no effects on survival?” said Andrew Hill, a senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

He said generic versions of the drug manufactured in India were sold at 200 euros per course.

(Reporting by Francesco Guarascio @fraguarascio; additional reporting by John Miller; Editing by Gareth Jones)

Countries turn to rapid antigen tests to contain second wave of COVID-19

By John Miller, Caroline Copley and Bart H. Meijer

ZURICH/BERLIN (Reuters) – Countries straining to contain a second wave of COVID-19 are turning to faster, cheaper but less accurate tests to avoid the delays and shortages that have plagued efforts to diagnose and trace those infected quickly.

Germany, where infections jumped by 4,122 on Tuesday to 329,453 total, has secured 9 million so-called antigen tests per month that can deliver a result in minutes and cost about 5 euros ($5.90) each. That would, in theory, cover more than 10% of the population.

The United States and Canada are also buying millions of tests, as is Italy, whose recent tender for 5 million tests attracted offers from 35 companies. Switzerland, where new COVID-19 cases are at record levels, is considering adding the tests to its nationwide screening strategy.

Germany’s Robert Koch Institute (RKI) now recommends antigen tests to complement existing molecular PCR tests, which have become the standard for assessing active infections but which have also suffered shortages as the pandemic overwhelmed laboratories and outstripped manufacturers’ production capacity.

PCR tests detect genetic material in the virus while antigen tests detect proteins on the virus’s surface, though both are meant to pick up active infections. Another type of test, for antibodies the body produces in response to an infection, can help tell if somebody has had COVID-19 in the past.

Like PCR (polymerase chain reaction) tests, antigen tests require an uncomfortable nasal swab. They can also produce more “false negatives,” prompting some experts to recommend they only be used in a pinch.

Still, the alarming rise in new infections globally has health officials desperately pursuing more options as the winter influenza season looms.

The World Health Organization reported more than 2 million new cases last week, bringing the total worldwide to 37 million, with more than 1 million deaths from COVID-19.

“These point-of-care tests could make a big difference,” said Gerard Krause, epidemiology department director at Germany’s Helmholtz Centre for Infection Research.

NO TEST NO FLIGHT

Krause said low-priority patients – those without symptoms – could initially be screened with antigen tests, leaving the more accurate PCR tests for those showing signs of the disease.

Antigen tests have already gained traction in the travel industry. Italian airline Alitalia offers Rome-Milan flights exclusively for passengers with negative tests and Germany’s Lufthansa has announced similar testing plans.

But the pandemic’s vast scale has strained the ability of countries to test all of their citizens, making it difficult to track the twisting paths of infection comprehensively and prevent a resurgence.

In the United States, for example, reliance on automated PCR machinery over the summer left many patients frustrated as they waited for a week or more for results.

Testing in Europe has also suffered glitches.

France does over a million tests a week but its free-for-all testing policy has led to long queues and delays in results, prompting French researchers to come up with a test they say can produce results in 40 minutes, without using a swab.

Italy does between 800,000 and 840,000 tests a week, more than double April’s levels, according to the Ministry of Health. But a government adviser, University of Padua microbiology professor Andrea Crisanti, said the country needs 2 million tests a week to really get on top of the virus.

In the Netherlands, where infection rates are among Europe’s highest, the government has been scrambling to expand weekly testing and lab capacity to 385,000 by next week from 280,000 now. The target is nearly half a million tests a week by December and just under 600,000 by February.

But people have been waiting days for a test. The authorities blame the overwhelming demand from those without clear symptoms for clogging up the system.

In response, the authorities have restricted rapid antigen tests to health workers and teachers, while others go on a waiting list.

‘GOLD STANDARD’

The various hitches highlight a conundrum for governments: how to get people back to work while tracing the virus within the population quickly – without running out of supplies.

Siemens Healthineers, which on Wednesday announced the launch of a rapid antigen test kit in Europe that can deliver a result in 15 minutes, said the volumes of such diagnostic tests being circulated globally now are “at the limits” of what manufacturers can supply.

Rivals including Abbott Laboratories and Becton Dickinson also offer numerous COVID-19 diagnostic tests, with more and more companies jumping in.

Swiss diagnostics maker Roche, announced plans on Tuesday to launch a new antigen test by the end of the year. Its fully automated systems can provide a test result in 18 minutes and a single lab machine can process 300 tests an hour.

By early 2021, the Basel-based company said it could make some 50 million of the new tests a month, on top of the rapid point-of-care tests it already sells.

Roche said the test could be deployed in places such as nursing homes or hospitals, where speedy results could thwart a potentially lethal outbreak.

“The primary use case is the testing of symptomatic patients,” a Roche spokeswoman said. “The secondary use case is the testing of individuals suspected of infection … which could also include asymptomatic patients.”

Expert opinion, however, on just how to use antigen tests is evolving and remains the subject of debate.

Switzerland, where reported new infections spiked to 2,823 cases on Wednesday from as low as three per day in June, is only now validating the accuracy of the rapid tests.

“Deployment of the rapid tests – where it makes sense – will be integrated into our testing strategy,” a spokesman for the Swiss federal health ministry said. “We’ll update our testing recommendations in November.”

Sandra Ciesek, director of the Institute of Medical Virology at the University Clinic in Frankfurt, Germany said rapid antigen tests could be an option for asymptomatic patients planning to visit elderly patients at nursing homes.

But people should refrain from using them as a definitive substitute to judge their infection status.

“The PCR test remains the gold standard,” Ciesek said. “An antigen test should only be used as an alternative if PCR is not possible in a timely manner.”

(Reporting by John Miller in Zurich, Caroline Copley in Berlin, Emilio Parodi and Giselda Vagnoni in Milan, Josephine Mason in London, Bart Meijer in Amsterdam and Matthias Blamont in Paris; Editing by David Clarke)