Piazza Navona square is seen deserted, as the spread of the coronavirus disease (COVID-19) continues, in Rome, Italy, April 28, 2020. REUTERS/Yara Nardi
ROME (Reuters) – Deaths from the COVID-19 epidemic in Italy climbed by 382 on Tuesday, against 333 the day before, the Civil Protection Agency said, while the total of people infected since the start of the outbreak topped 200,000.
The daily tally of new infections stood at 2,091, higher than the 1,739 recorded on Monday.
The daily death toll of 382 was the highest since Saturday, and Italy’s total number of fatalities since its epidemic came to light on Feb. 21 now stands at 27,359, the agency said — the second highest in the world after that of the United States.
The total of officially confirmed cases, which includes those who have died and recovered, amounts to 201,505, the third highest global tally behind those of the United States and Spain.
People registered as currently carrying the illness fell to 105,205 from 105,813 on Monday.
There were 1,863 people in intensive care on Tuesday against a previous 1,956, maintaining a long-running decline. Of those originally infected, 68,941 were declared recovered against 66,624 a day earlier.
The agency said 1.275 million people had been tested for the virus against 1.237 million the day before, out of a population of around 60 million.
Reporting by Gavin Jones, editing by Crispian Balmer
MADRID (Reuters) – Spain announced a four-phase plan on Tuesday to lift one of the toughest coronavirus lockdowns in Europe and return to normality by the end of June as the daily death toll fell to 301, less than a third of a record high of 950 in early April.
A woman walks past the closed terrace of a bar during lockdown, amid the coronavirus disease (COVID-19) outbreak, in Ronda, southern Spain, April 28, 2020. REUTERS/Jon Nazca
Prime Minister Pedro Sanchez said the lifting of the measures that have halted public life since March 14 and nearly paralysed the economy, will begin on May 4 and vary from province to province. Each phase is designed to last two weeks.
The progression to higher phases with fewer restrictions will depend on factors such as how the rate of infection evolves, the number of intensive care beds available locally and how regions comply with distancing rules, he said, without providing concrete thresholds for such evaluation.
While restaurants can start opening terraces at no more than 30% of their capacity during the first phase, remote working will be recommended where possible until reaching the last phase of the plan at some point in June, when beaches would also be able to reopen with the support of local authorities.
“We are starting to glimpse an outcome that will be a reward for the huge collective effort made over the past weeks,” Sanchez said, warning that the “virus is still lurking.”
“It’s up to the people now, we are embarking on a journey without a precise route map … What we’ve accomplished is enormous but it could all be lost if we don’t look after each other,” he said.
Sanchez explained the government had chosen not to set precise deadlines for the easing of the lockdown, as had countries such as Italy, to avoid missing them in what is a fluid situation.
Total fatalities since the start of the outbreak rose to 23,822 on Tuesday, with the daily increase coming down from Monday’s 331, the health ministry said. The number of diagnosed cases rose to 210,773 – the world’s second-highest after the United States.
As data published on Tuesday brought further evidence of a worsening in unemployment, companies said they were looking to the government to allow a gradual restart of the economy.
“The important thing is to resume our activities in order to really avoid this drama that we are living,” Antonio Garamendi, head of the CEOE business association, told RNE radio.
Sanchez also warned there would be a recession of “extraordinary scale” this year that will demand an extraordinary response from the European Union.
The first-quarter unemployment rate rose to 14.4% from 13.8% in the preceding three months, the National Statistics Institute said. That data only partially reflected the impact of the lockdown that began two weeks before the end of the quarter.
According to forecasts by the Bank of Spain, the coronavirus crisis could push the unemployment rate up to 21.7% this year, with the economy contracting as much as 12.4%.
“The authorities will set the pace,” Jose Antonio Alvarez, CEO of Santander, told a news conference after the euro zone’s second largest bank by market value reported an 82% slide in profit on provisions booked for the pandemic.
“What we are looking at is how we can adapt our spaces and our ways of working to an orderly return. As far as the tests are concerned, the health authorities are the ones who have the last word on how to carry out this process,” he said, adding that the banking group had a global framework for testing staff.
Reporting by Emma Pinedo, Clara-Laeila Laudette, Belen Carreno, Inti Landauro, Jesus Aguado,; Writing by Andrei Khalip,; Editing by Ingrid Melander, Philippa Fletcher and Alexandra Hudson
Although today’s rheumatoid arthritis treatments can reduce symptoms, they often come with serious side effects. Results from a new mouse study suggest that a new light-activated drug delivery method helps confine treatments to the joints, which could reduce whole-body side effects.
In the U.S., 1.3 million people are currently diagnosed with rheumatoid arthritis, a chronic disease that causes painful joint swelling that can eventually lead to bone loss and joint deformities.
“Our delivery system decreased arthritis in our experimental model while carrying and delivering much lower quantities of drug than is required for currently approved treatment,” said Emilia Zywot, a doctoral candidate from the University of North Carolina in Chapel Hill and member of the team that developed the new drug delivery approach.
Ms. Zywot was scheduled to present this research at the American Society for Pharmacology and Experimental Therapeutics annual meeting in San Diego this month. Though the meeting, to be held in conjunction with the 2020 Experimental Biology conference, was canceled in response to the COVID-19 outbreak, the research team’s abstract was published in this month’s issue of The FASEB Journal.
For the new delivery approach, a drug is attached to vitamin B12 molecules that are engineered to respond to low levels of laser light. Transfusion is then used to deliver red blood cells loaded with the vitamin B12 molecules into mice, where the cells circulate until activated.
The drug is only activated in areas that receive a low level of long-wavelength laser light, which can be administered from outside the body. This controllable activation allows a high concentration of drug to be released at the site of inflammation, thus requiring overall lower whole-body, or systemic, amounts of the drug for effective treatment.
To test their new method, the researchers administered the arthritis drug dexamethasone to arthritic mice via traditional injections and the light-based delivery system. Laser light was used to activate the light-responsive drug in an arthritic paw. They found that the light-based delivery system decreased arthritis using a three-fold lower dose of dexamethasone.
We hope that our drug delivery platform will better control drug delivery and decrease the amount of systemic exposure and off-target effects. We envision that it will be useful for any drug that can be synthetically attached to our light-responsive system, making it amenable to applications beyond arthritis.”
Emilia Zywot, a doctoral candidate from the University of North Carolina in Chapel Hill
The researchers plan to further investigate the light responsive drug delivery system in mouse models of arthritis to better understand efficacy of the new system compared to current treatments.
Ryan Gamlin spent a decade on the business side of health care — working with insurance companies. That was before he went to medical school. Now, he’s an anesthesiologist in Los Angeles and on the front lines fighting COVID-19.
It’s an experience he described as “scary, in a way that I never expected to be scared, going to work.”
He was frightened one day last summer, too, when a California wildfire came within feet of the hospital where he was working. But then, a fleet of firetrucks showed up to protect the hospital.
“City, county, park service, forest service, new trucks, old trucks, unmarked trucks,” Gamlin tweeted.
These days, with medical equipment from masks to ventilators in short supply, he’s been thinking back to that experience.
“I realized the fundamental difference between public safety and health care. Public safety is built on latent capacity,” he said. “We pay for people and equipment to stand idle, overprepared for emergencies.”
For Episode 3, we spoke with Gamlin about his experiences on both the business and medical side of health care.
“We’ve left no latent capacity in health care,” he said. “Everyone was working at their maximum,” even before COVID-19, he wrote in a Twitter thread.
“And some part of the tragedy that’s now unfolding in this country is because of that. Because we let health care become a business. And because businesses don’t keep a hundred extra fire trucks around, their crews trained and ready, just in case.”
“SEASON-19” of “An Arm and a Leg” is a co-production of Kaiser Health News and Public Road Productions.
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WASHINGTON (Reuters) – The federal government must “honor its obligations” and pay private insurers $12 billion owed to them under an Obamacare provision aimed at encouraging them to offer medical coverage to uninsured Americans, the U.S. Supreme Court ruled on Monday.
FILE PHOTO: The Supreme Court building exterior seen in Washington, U.S., January 21, 2020.REUTERS/Sarah Silbiger./File Photo
The 8-1 ruling authored by liberal Justice Sonia Sotomayor paves the way for a significant one-time cash infusion for major companies such as Humana Inc, Anthem Inc and Centene Corp. The justices reversed a lower court’s ruling that Congress had suspended the government’s obligation to make such payments under the Affordable Care Act, widely known as Obamacare.
Unlike other litigation involving Obamacare – long targeted by Republicans for repeal in Congress or invalidation through the courts – this case concerned only payments to insurers and did not directly challenge the law itself.
The Supreme Court in its next term, which starts in October, is set to hear a more politically freighted case concerning a bid by 20 Democratic-led states including California and New York to preserve Obamacare in the face of a challenge by Republican-led states backed by President Donald Trump’s administration. [L1N2AV0MJ]
In Monday’s ruling, the court sided with insurers that had argued that the lower court ruling would have let the government pull a “bait-and-switch” and withhold money the companies were promised.
“The government should honor its obligations,” Sotomayor wrote.
Justice Samuel Alito, one of the five conservative justices, was the sole dissenter, saying the court’s ruling “has the effect of providing a massive bailout for insurance companies that took a calculated risk and lost.”
Moda Health Plan Inc and other insurers that sued to try to compel the U.S. Department of Health and Human Services (HHS) to make the payments have said the government was supposed to help them recover from early losses they suffered after the law was passed by Congress in 2010 and signed by Trump’s Democratic predecessor Barack Obama.
The law has enabled millions of Americans who previously had no medical coverage to obtain insurance, including those with pre-existing medical conditions.
Other insurers involved in the case included Blue Cross and Blue Shield of North Carolina, Maine Community Health Options and Land of Lincoln Mutual Health Insurance Company.
“We appreciate that today’s Supreme Court 8-1 decision ensures that the federal government honors the obligations it made for services the private sector already delivered,” said Matt Eyles, president of America’s Health Insurance Plans, an industry group representing insurers.
An HHS spokeswoman said officials were “disappointed in the court’s ruling.”
Payments would have come through the law’s so-called risk corridor program designed to mitigate insurers’ risks from 2014 to 2016, when they sold coverage to previously uninsured people through exchanges established under Obamacare.
Insurers that paid out significantly less in claims on policies sold through the exchanges than they took in from premiums provided some of their gains to the government. Insurers that paid out more were entitled to government compensation for part of their losses.
From 2015 through 2017, Congress passed legislation barring HHS from using general funds to pay the government’s risk corridor obligations. Health insurers turned to federal courts to obtain the payments.
The U.S. Court of Appeals for the Federal Circuit ruled in 2018 that Congress effectively repealed its obligation to pay the insurers, prompting the insurers to appeal to the Supreme Court.
In a case directly challenging Obamacare, the Supreme Court in 2012 upheld the bulk of the law. Three years later, it rejected another challenge to it.
Reporting by Lawrence Hurley; Additional reporting by Nate Raymond; Editing by Will Dunham
MILAN/LONDON (Reuters) – Italian and British medical experts are investigating a possible link between the coronavirus pandemic and clusters of severe inflammatory disease among infants who are arriving in hospital with high fevers and swollen arteries.
Britain’s Secretary of State for Health Matt Hancock at Downing Street, following the outbreak of the coronavirus disease (COVID-19), London, Britain, April 27, 2020. REUTERS/John Sibley
Doctors in northern Italy, one of the world’s hardest-hit areas during the pandemic, have reported extraordinarily large numbers of children aged under nine with severe cases of what appears to be Kawasaki disease, more common in parts of Asia.
In Britain, doctors have made similar observations, prompting Health Secretary Matt Hancock to tell a coronavirus news briefing on Monday that he was “very worried” and that medical authorities were looking at the issue closely.
Kawasaki disease, whose cause is unknown, often afflicts children aged under five and is associated with fever, skin rashes, swelling of glands and, in severe cases, inflammation of arteries of the heart.
England’s national medical director, Stephen Powis, told the British briefing he had become aware of reports of severely ill children with Kawasaki-like symptoms in the past few days but stressed it was too early to determine a link with coronavirus.
“I’ve asked the national clinical director for children and young people to look into this as a matter of urgency … We’re not sure at the moment.”
In Italy, paediatricians are also alarmed.
A hospital in the northern town of Bergamo has seen more than 20 cases of severe vascular inflammation in the past month, six times as many as it would expect to see in a year, said paediatric heart specialist Matteo Ciuffreda.
Ciuffreda, of the Giovanni XXIII hospital, said only a few of the infants with vascular inflammation had tested positive for the new coronavirus, but paediatric cardiologists in Madrid and Lisbon had told him they had seen similar cases.
He has called on his colleagues to document every such case to determine if there is a correlation between Kawasaki disease and COVID-19. He aims to publish the results of the Italian research in a scientific journal.
Ciuffreda said his first case of apparent Kawasaki disease was a nine-year-old boy who came to hospital on March 21, at the peak of the coronavirus outbreak, with high fever and low blood oxygen levels. He tested negative for coronavirus.
A scan showed he had an enlarged coronary artery, a hallmark of severe cases of Kawasaki disease, he said.
“The little boy worried me a lot, with a violent multi-organ inflammation affecting both heart and the lungs,” he said. “I feared he wouldn’t survive but surprisingly, in the course of a few days, he took a positive turn and he got better.”
Kawasaki disease was also anecdotally linked 16 years ago to another known coronavirus, though it was never proven.
The research was carried out after another, related coronavirus known as NL63 was found in a baby showing symptoms of Kawasaki disease in 2004.
FILE PHOTO: National Medical Director of NHS England Stephen Powis attends a news conference on the ongoing situation with the coronavirus disease (COVID-19) in London, Britain March 21, 2020. Jonathan Brady/Pool via REUTERS/File Photo
Professor Ian Jones, professor of virology at the University of Reading in Britain, said the NL63 virus uses the same receptor as the new coronavirus to infect humans but also stressed that it was too early to draw conclusions.
“We just have to wait and see if this becomes a common observation,” he said.
The American Academy of Pediatrics has yet to see something similar in the United States, which has the most number of coronavirus infections and deaths.”We are not aware of any reports of this phenomenon in the United States,” Dr Yvonne Maldonado, who chairs the academy’s committee on infectious disease, said in an email referring to a potential link between COVID-19 and Kawasaki-type symptoms.
Additional reporting by Julie Steenhuysen in Chicago; Editing by Mark Bendeich and Alison Williams
NEW YORK/CHICAGO (Reuters) – Another wave of U.S. states are preparing to lift coronavirus restrictions this week against the warnings of many public health experts as the White House sees this month’s jobless rate hitting 16% or higher.
Health experts say increased human interaction could spark a new wave of cases of COVID-19, the respiratory disease caused by the highly contagious virus that has already killed more than 54,300 Americans.
Colorado, Mississippi, Minnesota, Montana and Tennessee will join other states beginning an experiment to reopen economies without the testing and contact-tracing infrastructure health experts say is needed to prevent a resurgence of infections, with lives in the balance.
Georgia, Oklahoma, Alaska and South Carolina have already taken steps to restart their economies following a month of government-ordered lockdowns.
Those unprecedented restrictions resulted in a record 26.5 million Americans filing for unemployment benefits since mid-March. The nonpartisan Congressional Budget Office predicted on Friday that the economy would contract at nearly a 40% annual rate in the second quarter. Even next year, the CBO forecast the unemployment rate averaging above 10%.
White House economic adviser Kevin Hassett told reporters the U.S. jobless rate would likely hit 16% or more in April.
“I think the next couple of months are going to look terrible,” Hassett said on Sunday. “You’re going to see numbers as bad as anything we’ve ever seen before.”
Against a backdrop of scattered protests across the country calling for stay-at-home orders to be lifted, U.S. cases topped 940,000 on Sunday after posting a record one-day increase on Friday.
New York and other states have extended restrictions to mid-May. New York reported 367 new deaths on Sunday, its lowest increase since March 30. Democratic Governor Andrew Cuomo said construction and manufacturing would be the first businesses to reopen and could restart after May 15 in the upstate region with certain precautions and if cases continue to decline.
Other states, mainly those with Republican governors, have taken a more aggressive approach.
Tennessee said it will allow restaurants to reopen on Monday. Mississippi’s stay-at-home order expires the same day.
Montana, which reported three new cases on Sunday, is allowing businesses to reopen Monday if they limit capacity and practice social distancing, while Minnesota will let some businesses restart on Monday, allowing 80,000 to 100,000 people in the industrial, manufacturing and office jobs to go back to work.
In Colorado, Democratic Governor Jared Polis has given the green light for retail curbside pickup to begin on Monday. Hair salons, barbershop and tattoo parlors can open on Friday, with retail stores, restaurants and movie theaters to follow.
Royal Rose is reopening her tattoo studio in Greeley, Colorado this week after closing a month ago, not because she wants to but because the bills are piling up and she says she has no choice.
“I would stay home if the government encouraged that, but they’re not, they’re saying ‘Hey, the best thing to do is go back to work, even though it might be risky,’” said Rose, 39, sitting inside her salon in a wood-sided building on a leafy street in the farming and oil town.
But the lifting of restrictions is not uniform across most states. For example, Denver extended stay-at-home orders to May 8 but city dwellers can drive to a nearby county for a haircut. Georgia prohibited any local laws stricter than the state law.
The U.S. Capitol is seen from the Washington Monument, amid the spread of the coronavirus disease (COVID-19), in Washington, U.S., April 25, 2020. REUTERS/Erin Scott
Eight states never ordered residents to stay at home — Arkansas, Iowa, Nebraska, North Dakota, Oklahoma, South Dakota, Utah and Wyoming.
Several opinion polls have shown a bipartisan majority of Americans want to remain at home to protect themselves from the coronavirus, despite the impact to the economy.
(This story has been refiled to fix typo in “Greeley” in paragraph 14)
Reporting by Nick Brown in New York and Brendan O’Brien in Chicago; Additional reporting by Tim Ahmann in Washington and Maria Caspani in New York; Writing by Lisa Shumaker; Editing by Daniel Wallis
MOSCOW (Reuters) – Russia could experience a spike in cases of the new coronavirus if people flout lockdown measures during public holidays scheduled for early May, a top health official said on Sunday.
FILE PHOTO: Medical specialists transport a person on a stretcher into an ambulance outside a hospital for patients infected with the coronavirus disease (COVID-19) on the outskirts of Moscow, Russia April 21, 2020. REUTERS/Tatyana Makeyeva
The number of coronavirus cases in Russia began rising sharply this month, reaching more than 80,000 on Sunday after a record 6,361 new cases were registered over the past day.
Anna Popova, head of Russia’s consumer health watchdog, said the country had so far avoided a spike in cases and could continue to do so “if only we do not give up during the holidays”.
“That is the biggest risk today,” Popova said in an interview on state television, Russian news agencies reported.
Russia only has a handful of working days between May 1 and May 11 this year, with back-to-back long weekends for the Labour Day and Victory Day state holidays. Many Russians typically take the entire period off work for travel or family holidays.
Russia, which has so far recorded 747 coronavirus-related deaths, has declared lockdowns across the country, including in the capital Moscow, the area worst-affected by the virus.
Muscovites are only allowed to go out to buy food or medicines at their nearest shop, get urgent medical treatment, walk their dog, or take out the trash. They must apply for a digital permit for any other movement across the city.
Popova urged Russians to remain home during the holidays in a bid to help stem contagion.
“We owe it to ourselves and our loved ones,” she said.
President Vladimir Putin announced this month that Russia would postpone its May 9 celebrations, including a massive military parade across Red Square to mark 75 years since the Soviet victory in World War Two.
The Ministry of Defence said on Sunday that 874 troops had tested positive for the virus since March, as well as 779 cadets and students of military academies across the country.
The ministry said earlier this week it had ordered thousands of troops to remain in quarantine for two weeks after the Red Square military parade was called off. [L8N2C83HF]
Next week Putin will address the measures needed to curb the spread of the coronavirus, Kremlin spokesman Dmitry Peskov said on Sunday, Russian news agencies reported.
Reporting by Gabrielle Tétrault-Farber and Gleb Stolyarov; Editing by Peter Graff and David Clarke
(Reuters) – In the race to develop a vaccine to end the COVID-19 pandemic, governments, charities and Big Pharma firms are sinking billions of dollars into bets with extraordinarily low odds of success.
FILE PHOTO: Small bottles labbeled with a “Vaccine COVID-19” sticker and a medical syringe are seen in this illustration taken taken April 10, 2020. REUTERS/Dado Ruvic/Illustration
They’re fast-tracking the testing and regulatory review of vaccines with no guarantee they will prove effective. They’re building and re-tooling plants for vaccines with slim chances of being approved. They’re placing orders for vaccines that, in the end, are unlikely to be produced.
It’s the new pandemic paradigm, focused on speed and fraught with risks.
“The crisis in the world is so big that each of us will have to take maximum risk now to put this disease to a stop,” said Paul Stoffels, chief scientific officer at Johnson & Johnson (JNJ.N), which has partnered with the U.S. government on a $1 billion investment to speed development and production of its still-unproven vaccine. “If it fails,” Stoffels told Reuters, “it will be bad.”
Historically, just 6% of vaccine candidates end up making it to market, often after a years-long process that doesn’t draw big investments until testing shows a product is likely to work. But the traditional rules of drug and vaccine development are being tossed aside in the face of a virus that has infected 2.7 million people, killed more than 192,000 and devastated the global economy. With COVID-19, the goal is to have a vaccine identified, tested and available on a scale of hundreds of millions of doses in just 12 to 18 months.
Drug companies and the governments and investors that finance them are boosting their “at-risk” spending in unprecedented ways. The overriding consensus among more than 30 drug company executives, government health officials and pandemic-response experts interviewed by Reuters is that the risks are necessary to ensure not only that a vaccine for the new coronavirus is developed quickly, but that it is ready to distribute as soon as it’s approved.
Investments from governments, global health groups and philanthropies have been aimed primarily at the most promising of the more than 100 vaccine candidates in development worldwide. But only a handful of those have advanced to human trials, the real indicator of safety and efficacy – and the stage where most vaccines wash out.
Even among the more encouraging prospects, very few are likely to succeed. It’s possible more than one will work; it’s possible none will.
For companies in the race, there are some likely benefits: It’s a proving ground for vaccine technologies and a chance to burnish reputations and boost shares. While some large companies, including Johnson & Johnson and GlaxoSmithKline Plc (GSK.L), have said they plan to make the vaccine available at cost – at least at first – they may reap profits down the road if seasonal vaccination is needed and countries invest in stockpiles.
But finding a vaccine that works does little good without the ability to produce and distribute it. That means building manufacturing plants now.
“We want to make investments up front, at risk, even before we know the vaccines work, to be able to (immediately) manufacture them at a scale of tens or hundreds of millions of doses,” said Richard Hatchett, a physician who managed U.S. pandemic flu policy under former President George W. Bush and returned to advise the Obama White House during the 2009 swine flu pandemic.
Hatchett now heads the Coalition for Epidemic Preparedness Innovations (CEPI), a vaccine-development consortium supported by private donors as well as the United Kingdom, Canada, Belgium, Norway, Switzerland, Germany and the Netherlands. The organization has raised more than $915 million of the $2 billion it anticipates spending to accelerate testing and build specialized production plants for at least three coronavirus vaccine candidates.
In the United States, the Biomedical Advanced Research and Development Authority (BARDA), a federal agency that funds disease-fighting technology, has announced investments of nearly $1 billion to support coronavirus vaccine development and the scale-up of manufacturing for promising candidates.
One underlying fear, shared by everyone Reuters interviewed, is that even if a vaccine does prove effective, there won’t be enough to go around.
Having reserves ready worldwide to immediately inoculate critical populations – health care workers, the elderly, people made vulnerable by medical conditions – would stamp out the pandemic faster and reignite economies, Hatchett said. The alternative, he said, is a replay of past pandemics, including the H1N1 influenza outbreak of 2009, with wealthy countries hoarding the vaccines.
If that happens, pandemic experts warn, infection hot spots will continue to pop up, each with the potential to create a new wave of illness.
FULL SPEED AHEAD
The scale of the coronavirus vaccine race has no historical parallels. CEPI has identified at least 115 ongoing vaccine initiatives worldwide. And the race is shattering norms of speed and safety in drug and vaccine development.
Some developers are running safety and efficacy trials in tandem, instead of sequentially, as is typical, and short-cutting traditional testing protocols. Others are working with regulators in multiple countries simultaneously, looking for the quickest path to market.
The resulting uncertainty makes it especially risky to invest in manufacturing facilities for a given candidate, since different types of vaccines can require very distinct production lines.
Many of the candidates attracting the most investment rely on proven vaccine approaches being adapted by Big Pharma companies with regulatory and production acumen. Some funders are gambling on smaller biotech companies and academic labs, which may have promising technologies but little to no experience getting a drug or vaccine approved and produced at scale.
BARDA, the U.S. R&D agency, is one of the biggest vaccine funders, with some $5 billion to spend. The agency plans to invest in five vaccine candidates, focusing mostly on projects from experienced drug makers.
“Each is coming with a lot of prior experience,” said Rick Bright, who until this month was BARDA’s director. “They all know how to scale up.”
In one of its biggest bets, BARDA is pouring nearly $500 million into a J&J effort.
J&J’s coronavirus vaccine candidate uses a cold virus, rendered harmless, to deliver genes derived from the spiky, crown-shaped proteins on the surface of the new coronavirus, prompting an immune response.
J&J is using the same technology to develop vaccines for other viruses, including Ebola. While none has completed testing and won full U.S. approval, trials so far in tens of thousands of people have produced data showing the basic approach is safe, which could speed regulatory approval for the new coronavirus vaccine. But it’s far from a sure bet: Animal test data, due this summer, will give the first hint of the vaccine’s effectiveness and human trials will begin in September.
“By end of the year, we’ll know whether it protects humans,” said Stoffels, J&J’s chief science officer.
In China, CanSino Biologics Inc (6185.HK) has vaccine technology similar to the one being used by J&J. CanSino is further along with its testing, having announced this month that its candidate had cleared initial safety trials in humans and was set to advance to the next stage.
Sanofi SA (SASY.PA), the world’s largest vaccine maker, has attracted BARDA money for another proven approach, based on its approved Flublok flu shot. Sanofi uses insect cells instead of the traditional chicken eggs to grow the genetically altered virus proteins used to spur an immune response.
Not all the vaccine projects getting attention have a Big Pharma pedigree.
Moderna Inc (MRNA.O), a biotech firm based in Cambridge, Massachusetts, was the first in the United States to begin human trials when it began testing its vaccine last month. Working with the U.S. National Institutes of Health, the company received seed money from CEPI, and this month, BARDA kicked in $483 million to support the vaccine’s development and help scale up manufacturing. That includes hiring 150 skilled workers to eventually produce vaccine around the clock.
Moderna’s vaccine uses genetic material called messenger RNA (mRNA) to instruct cells in the body to make specific coronavirus proteins that then produce an immune response.
No mRNA vaccine has ever been approved for public use, but the technology is drawing interest, in part because it makes a vaccine easier to design and produce in vast quantities.
“The end game is millions of doses,” Tal Zaks, Moderna’s chief medical officer, told Reuters. The company hopes to have an approved vaccine available as early as March 2021, and possibly before then for healthcare workers. German vaccine makers CureVac and BioNTech SE (22UAy.F) (BNTX.O), which is partnering with Pfizer Inc (PFE.N), are preparing to begin trials with similar mRNA-based vaccine candidates. So is Lexington, Massachusetts-based Translate Bio Inc (TBIO.O), which is working with Sanofi.
Even for vaccine hopefuls already in human tests, it will be months before there’s conclusive evidence on safety and effectiveness – something funders are keenly aware of.
The rush has prompted scientists to consider previously unthinkable shortcuts.
Normally, vaccines would need to undergo clinical trials involving thousands of people before widespread inoculation is allowed. But after testing a prospective vaccine in a smaller group to ensure it is not toxic, Swiss researchers seek to “immunize a lot of the Swiss population in the next six months and then produce for a world market,” Dr Martin Bachmann, head of immunology at Inselspital, the University Hospital of Bern, said this week.
A spokesman for Swissmedic, the country’s drug regulator, said it was in contact with Bachmann’s group and would not allow trials until the agency is assured that safety risks are addressed.
The Swiss vaccine employs virus-like particles to provoke an immune response, an approach that theoretically is considered safer because it does not directly expose people to the actual coronavirus. So far, it has only been tested in mice.
Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic in Rochester, Minnesota, is among those worried about the risks of injecting a large group of people with a vaccine that has only been through minimal testing in humans.
“I don’t see how this is possible,” he told Reuters, referring to Inselspital’s plan.
The war on COVID-19 is haunted by lessons from the fight against another virus a decade ago.
In the spring of 2009, the H1N1 swine flu virus emerged in the United States and Mexico and spread worldwide. Within weeks, the World Health Organization(WHO) declared it the first pandemic since 1968.
Wealthier governments that had provisional contracts with vaccine makers immediately exercised them, “effectively monopolizing the global vaccine supply,” according to Hatchett and numerous official reports. The U.S. alone ordered 250 million doses, and Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland and Britain all had vaccine.
Under pressure from the WHO, those countries ultimately committed to share 10% of their stockpiles with poorer nations. But due to production and distribution snarls, only about 77 million doses were shipped – far less than needed – and only after the disease had peaked in many regions.
If an effective vaccine emerges for the new coronavirus, a replay is possible, experts in pandemic preparedness say. None of the global health authorities consulted by Reuters believes there will be sufficient supplies to satisfy the immediate demand. Governments will be under tremendous pressure to immunize their own citizenry and get life back to normal, so hoarding remains a serious risk.
Ronald St. John, a physician who has held government posts on infectious disease control in the United States and Canada, expects a similar scenario with vaccines.
“There is going to be a lot of self-interest in terms of the production,” he said.
BARDA explicitly gives preference to vaccine projects promising U.S. production capacity.
“We’re asking the American taxpayer to give a lot” to the vaccine effort, so it’s important to ensure U.S. access to any successful vaccine, said Bright, BARDA’s recent chief.
But he added that BARDA also is encouraging the companies it backs to build manufacturing capacity outside the United States, “so we can have a global supply all at once.”
Many governments are pouring money into vaccine initiatives with expectations that they will be first in line if a viable vaccine emerges.
Arcturus Therapeutics Holdings Inc (ARCT.O), a San Diego biotech, is receiving up to $10 million from the Singapore government to develop its mRNA-based coronavirus vaccine candidate in partnership with the Duke-National University of Singapore Medical School. If the vaccine is approved, Singapore gets first access, said Arcturus CEO Joseph Payne. Everything after that, he said, goes to “whoever pays for it.”
“Arcturus is not responsible for the ethics of distribution – governments are – but in order for governments to get the vaccine, they need to pay for it,” Payne said. “The country that will win is the country that stockpiles multiple vaccines at risk.”
The company raised $80.5 million this week from a common stock public offering.
In China, a major global producer of vaccines, the government is backing several coronavirus vaccine projects, raising the prospect it will inoculate its 1.4 billion people first. One government-backed effort, by Sinovac Biotech Ltd. (SVA.O), is already testing vaccine candidates in humans and awaiting initial data..
Sinovac got 60 million yuan ($8.4 million) in low-rate credit lines through a discount loan program supported by China’s central bank. Government officials quickly made land available for the company to build production plants, including a factory meant to produce up to 100 million doses a year of its coronavirus vaccine.
Sinovac would not discuss how much public money is being invested. The relevant government agencies declined requests for comment.
On Friday, the World Health Organization announced a “landmark collaboration” across the international community to raise $8 billion to accelerate the coronavirus vaccine development and ensure equitable access worldwide to any successful vaccine. Countries across Europe, Asia, Africa, the Middle East and the Americas announced their participation, but the United States and China, two of the world’s biggest pharma forces, did not.
“There will be no U.S. official participation,” a spokesman for the U.S. mission in Geneva told Reuters, adding that the U.S. supports “global cooperation to develop a vaccine.”
Broader questions about U.S. policy on international vaccine distribution are still under consideration within the Trump administration, according to a member of the White House coronavirus task force who spoke to Reuters on condition of anonymity. The official noted that the U.S. Department of State and the U.S. Agency for International Development are spending nearly $500 million to assist with the COVID-19 response internationally.
A WHO spokeswoman said Friday’s announcement was the beginning of a global collaboration and “we would welcome more countries coming on board.” China did not respond to a request for comment.
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People involved in the global vaccine race told Reuters that the greatest incentive for countries to promise to share coronavirus vaccines may be the uncertainty around which ones will work.
Since no country can be sure the candidates it backs will prove successful, committing to sharing with other nations can help assure they’ll have an initial supply to inoculate health care workers and other critical populations.
“That’s enlightened self-interest, as well as a global public good,” said Jeremy Farrar, an infectious disease expert and director of the Wellcome Trust global health charity.
Steenhuysen reported from Chicago, Eisler from Washington, Martell from Toronto and Nebehay from Geneva; additional reporting by Matthias Blamont in Paris, Alexandra Harney in Hong Kong, Roxanne Liu in Beijing, John Miller in Zurich and Kate Kelland in London. Editing by Michele Gershberg and Julie Marquis.
(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Saturday reported 895,766 cases of new coronavirus, an increase of 30,181 cases from its previous count, and said that the number of deaths had risen by 1,623 to 50,439.
The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, as of 4 pm ET on April 24, compared with its count a day earlier. (here//www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html)
The CDC figures do not necessarily reflect cases reported by individual states.
Reporting by Shubham Kalia in Bengaluru; Editing by Chizu Nomiyama